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PS! If anyone has any suggestions on places to go/shop/visit/see/eat near Surfers Paradise, please lemme know in the comments – much appreciated!
—— 29.01.11 | outfit ——
Diva necklace worn as hair chain, vintage top, Disney for Diva pumpkin carriage bracelet, Maxi skirt c/o Robot Ninjas, ASOS bow belt, Novo tan wedges & vintage bag
This week:
1. Almost went to the St Kilda night market, until we found out it wasn't open this summer, extremely sad to hear :( Apparently they couldn't obtain a lease/policy agreement with the council.
2. Booked tickets to the Gold Coast for five days. There goes all the money i made at work this Summer!
3. Bought a leopard print cape and a beautiful dress i bought came in the mail – will share soon!
4. I listed some of my vintage on Ebay here, they are ending on Sunday night so be sure to take a peek :)
About my maxi skirt:
I am not kidding when i say this but, i feel tall in this maxi skirt. And i am not tall, by the way. 160cm to be exact. But there's just something about this paper bag waist and stretchy jersey like fabric that makes the design slimming. Whatever it was, i've been lounging in it both at home and in public quite a few days this week.
I just made myself a flickr account and used flickr to upload my photos for this post as i just found out that Tinypic makes my photos pixelated! My computer screen is somewhat retarded so i can't really tell, well to be honest everything on my screen looks a tiny bit pixelated to some degree so i didn't think much of it. But now i see it, and it's annoying me so i'm trialling some different photo sharing sites and right now i can't choose between flickr and photobucket. Please let me know if you've got an opinion on either :)
So i'll be soaking in the hopefully existent sun in the Gold Coast for the majority of this week. My sister is officially in charge of Vintage with Kani & Kani whilst i am absent. I will have minimal internet connection or in other words, no blogging at all. However, you can follow me on Twitter here, i'll most likely be tweeting. In fact, this week is going to be hectic. Because i just realised that it's my birthday and chinese new year. Expect photo diarrhea upon my return :)
Enjoy your week everyone – wherever you are around the world <3
Much love,
PS! If anyone has any suggestions on places to go/shop/visit/see/eat near Surfers Paradise, please lemme know in the comments – much appreciated!
—— 25.01.11 | outfit ——
I haven't posted about features and press in a long time now, so it's about time i update us all on the lovely and ever so exciting places K is for KANI has been! I just wanted to say before i start, that it is so amazing to see the positive response to a blog that once had no followers and readers (yes, once a upon a time i had no followers at all!). It is pretty much unbelievable that my favourite bloggers (hello typhanie!) have given this blog shout outs and stores i drool over have featured me on their blog. So, let's begin!
ModCloth Blog: Julie from ModCloth featured one of my favourite vintage finds, this carnival coloured jumper/cardigan on the ModCloth blog.
DameJolie: The lovely Gracie from DameJolie featured me wearing the DameJolie goldie leaf dress on both her homepage and fashbash flyers.
New York Mag: A lovely reader brought my attention to a photo of me in New York mag's 17th volume of Best of the Style Blogs. Rhiannon from Liebemarlene Vintage & Betty from Le Blog de Betty were in this slideshow too so i was pretty much jumping all over the moon when i found out i was here too!
Forever 21 Blog – The Skinny: Allie from the Forever 21 featured my neutrals outfit on The Skinny's new 'Fashion Face Off' feature, alongside the beautiful Hope from Pansy Lane :) I was wearing a wine coloured hat and some shorts from Forever 21. See here for more!
Absolutely Fabulous: Alina from Absolutely Fabulous, a Romanian magazine issued in conjunction with the Absolutely Favulous Fashion and Vintage Fair, interviewed me for their second issue of the mag. I had no idea there would be a whole double page spread dedicated to my blog and was so surprised when i saw it! The entire magazine is in the local language so if there's any readers from Romania, enjoy :)
Her World magazine: Chrystal from Singapore's #1 women's magazine, Her World, featured my vintage dress on an online feature about vintage fashion trends. I'm pictured alongside Megan from Another Day to Dress Up and Diya from In Her Stilettos, both very popular fashion bloggers so i'm so thrilled to be mentioned!
The ever so sweet Amanda from the Upside of Wonder featured me as December's blogger of the month. You can check out the interview here and thankyou, Amanda, for featuring K is for Kani!
I was also interviewed on French blog Slanelle Style here, who may i add, has beautiful outfit posts! I think i will always have an obsession with all things French and was so excited to see my words translated into french, i wish i could speak the language!
Lettie sent me these two beautiful artworks of hers. Thankyou so very much Lettie!
A drawing of me by Dana – it's so cute that there are flowers and hearts in my name by the way :):)
Also, i did an interview with Fresh Fashion Faces here, the lovely Santa from Strawberry Electric kindly featured me on her blog here, and Temi from Diary of a Short Girl featured me here! Urghh i feel like this is a total verbal diarrhea, but i haven't done one of these posts for at least half a year so no wonder i have so much to say!
There are a couple of exciting collaborations coming up, as well as some exciting giveaways as well. What can you win? Well for one, there's going to be scallops and leather. I'm also working on some other projects in promoting Vintage with Kani so you might also expect some fun in the sun vintage!
February will be the last month of my summer break before i head back to uni – i will be in second year this year. And! My birthday is in early february too :) Thankyou everyone for your support and love for K is for KANI, you've got me beaming so massively seeing all these kind words. I try to reply to most of your lovely messages but sometimes it gets extremely hard and time consuming and i simply don't have enough hours or spare time in the day. Hope you understand and know that i appreciate each and every comment and message i receive on my blog, lookbook, chictopia, etc! Much love from Australia and happy tuesday!
—— 19.01.11 | outfit ——
Saving my favourite ClubCouture dress for last. A few of you have emailed me asking if my previous dresses were still in stock, so i've decided to help you find this dress on their site, just in case anyone was interested in getting their own :) The black version is here. I call it my fairy dress because it just has the most whimsical looking pleats all over and the swing shape makes me feel like i'm in some secret garden hanging out with little fairies. There used to be a white and pink version (i have the pink one) but looks like they are gone, but i did find a look-a-like to my UO dress here! And 'CCBLOG15' gets you 15% off your order :)
As always, been hanging out at work too. My shifts are slowly dying down.. Had three last week, and three this week, though am getting four next week?! Also, our university timetabling system opened recently, and i have been spending quite a few un-fun hours trying to decide on what subjects i want to do. With my commerce/law (they really call it 'laws' it sounds so strange though!), we're are supposed to overload this semester and do five subjects instead of four. Trying to battle with my mind right now to convince myself i can do it.. but i don't know!
Spent a saturday night out with some family friends for dinner, wearing my little peter pan dress. Had some delicious icecream (haha) and average asian food.
My sister loves baking and filled my whole dslr sd card with photos of her baking.
Also, fun-est news to last. Kani, my etsy store, has been updated :) Brought in a bunch of lovely bow headbands made out of quirky vintage-inspired fabrics. Also, lots of woodlands inspired things as well. I must say that listing and making items is much more time consuming than it looks. I spent a whole night listing twelve items. Thinking of names and descriptions can be tough so i hope i did make sense with the stories i was writing about each of my headbands. You can be sure that i love each and one of them and hope you will too :) and for anyone that's interested, i can combine shipping for my etsy items & vintage ones!


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LINCOLN — Jordan Burroughs made all the rounds after returning from the Summer Games last August, going just about anywhere to sign autographs, pose for pictures or simply talk about realizing the Olympic dream.
It was a "ridiculous amount of places," the former Nebraska wrestler said Thursday, but he loved telling kids to aim high and sharing a glance or touch of his gold medal as inspiration.
Burroughs never thought that several months later a bureaucratic decision might put young wrestlers' Olympic dreams out of reach. the International Olympic Committee announced last month that it plans to eliminate wrestling from the Summer Games, starting in 2020.
"I spent months after the Olympic Games traveling around the country, telling kids this is possible and showing them my medal," he said. "I told them if they worked as hard as possible and made the sacrifices, this was possible for them. It's really upsetting for me to look at those kids and now realize they possibly will never have the chance to wrestle in the Olympic Games."
Burroughs returned this week from trips to Iran and Belarus, coming home for the first time since the Feb. 12 announcement that wrestling's spot in the Olympics was in jeopardy.
Efforts are being made to challenge the decision — and wrestling can still reapply for inclusion in the program — but Burroughs is among those still numb from the initial blow that has left him with mixed emotions over that gold medal that he treasured.
"At camps, I'd let kids pass it around and put it around their necks and get pictures taken with it," he said. "That's something they dream of. That's something they want to experience on their own. I pray they have that experience as well."
The hardest part, he said, was feeling helpless as he heard the news. He had just arrived in Iran for the Freestyle World Championships.
In his time overseas, however, Burroughs said one of the neat things was seeing Americans, Iranians and Russians all come together to save the fate of the sport.
"We're extremely competitive and we all want to win, and on the mat we're competitors and opponents," he said. "But with this whole ordeal going on, in the spirit of the Olympics we've kind of come together and basically joined forces to wrestle with the IOC now.
"The Iranian delegation, as well as the Russians, it's extremely important to those guys, even more important than here in America. We know wrestling's in the right hands."
Unfortunately, Burroughs said, there is not much that can be done individually, other than taking to social media, telling people about it and just "keeping it out there."
"we don't want to protest, don't want to be rebellious … but we want to do our part," he said.
"It's still scary because you never know. Basically we're thrown back into the gauntlet with a number of other sports trying to get back in for 2020. There's a lot of important people behind the cause, but still quite a bit to get done."
Wrestling joins seven other sports applying for spots on the program for 2020, a proposal that will be made in May. Some observers, though, have said it's unlikely that a sport would be voted back in so soon after being removed.
Burroughs, 24, is back in Lincoln. The former two-time NCAA champion at NU recently was named a semifinalist for the 2012 Sullivan Award and is training now for the U.S. Open next month in Las Vegas. He already has said he plans to wrestle in the 2016 Summer Olympics in Rio de Janeiro after being the youngest wrestler on the 2012 U.S. team in London.
So what about 2020? Burroughs said he's more concerned about the Olympic opportunity possibly being taken away from others than from him right now.
"It's quite a long ways away, so I'm just focusing on this," he said. "Once 2016 arrives, then I'll make the decision whether to keep wrestling or move on with my life."
Contact the writer:
402-444-1042, firstname.lastname@example.com, twitter.com/RKaipustOWH

subset: commoncrawl


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Save on every ticket. Guaranteed.
Coming off their FIRST EVER division crown, the Clippers enter 2013-14 as one of the clear title contenders in the NBA. After a highly productive tenure that produced a championship with the Celtics, Doc Rivers arrives at Staples Center to lead the loaded Clippers to the next level. And with Chris Paul, Blake Griffin and DeAndre Jordan at the foundation of Lob City, the Clippers aren't just good, they're alsi easily the most entertaining team in the league.
LA Clippers: A Brief History
Founded as the Buffalo Braves in 1970, the Clippers made the trek (probably less of a trek and more of a plane ride, to be fair) west to San Diego in 1978 where they would play for six seasons. In 1981, owner Irv Levin sold the franchise to Donald Sterling (now the longest tenured team owner in the NBA) who began the process of moving the team to his hometown of Los Angeles.
In 1984, the Clippers moved up the 5 to Los Angeles where they settled in at the Sports Arena for 15 years until the opening of the Staples Center. Though the LA Clippers have struggled for much of their four-decade history, the team has built a dedicated fan base despite the crowded marketplace. Though they have featured players such as Bill Walton, Danny Manning, Ron Harper and Elton Brand, the Clippers have regularly existed in the shadow of their in-town rivals, the Los Angeles Lakers. But no more.
In the 2009 NBA Draft, the Clippers used the first pick on Oklahoma star Blake Griffin and the franchise was reborn. Though he missed his first season with a knee injury, the Clippers built a contender around Griffin and DeAndre Jordan, a young center with tremendous upside. Bringing in Caron Butler, "Mr. Big Shot" Chauncey Billups and ultimately trading for Chris Paul, Lob City was born. The Golden Age of the Clippers? It's happening RIGHT NOW.
Lob City
After winning their first ever Pacific Division crown in 2013, the Clippers lost a heartbreaking opening-round series to the Memphis Grizzlies and changes were afoot. Re-signing Chris Paul for the long-term was priority number one and in order to ensure his return, the Clippers parted ways with Vinny Del Negro (who had performed admirably in his tenure) and brought in Doc Rivers. Once Paul was locked up, the Clippers had options. While they will miss Eric Bledsoe and his spark off the bench, the Clippers replace his production with sharpshooters JJ Reddick and Jared Dudley. Additionally, the Clip Show brought in former UCLA star Darren Collison to help run the offense and keep Chris Paul healthy for what the Clippers hope is a deep run in the playoffs.
Playing their home games at the beautiful downtown Staples Center which they share with the Lakers, Kings and the best concerts and events on the planet, the Clippers are the best show in town. Get out to Staples and watch Chris Paul, Blake Griffin and the Doc Rivers-led LA Clippers put on a show. ScoreBig.com for guaranteed savings.


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Karl Lagerfeld's latest crush, 'it' girl and model Alice Dellal, stars in the new ad campaign for Chanel's new bag for Spring/Summer 2012 – the Boy bag.
After meeting on a photo shoot Karl chose Alice to be the face of the new tougher, must-have Chanel bag. With her shaven undercut hairstyle and punk dress sense, Alice is the perfect choice to front this new campaign, which celebrates non-conformist femininity.
The newly released shots show Karl setting up the image and photographing his model, who poses in a rather grand, Parisian house setting looking like quite the punkish heiress in her quintessential fish net tights. She can be seen reclining on a sofa, desk and dressing table with that true Chanel spirit of decadence and rebellion.
Something of a current fashion favourite, Alice has also recently modelled for Agent Provocateur, Vivienne Westwood and Marc by Marc Jacobs.
More Fashion articles from handbag.com
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Update: Although not definitive, http://www.the-nextlevel.com/blog/resident-evil-2-3-and-dino-crisis-hitting-psn-within-the-next-3-months/ reports that Capcom's Chris Kramer stated the games will be out "within the next three months."
A few months ago it was first reported that Capcom classics were making their way to Sony's PlayStation Network.
Today the green flag was given to three more, specifically, the http://www.esrb.org/index-js.jsp has now rated Dino Crisis, Resident Evil 2 and Resident Evil 3: Nemesis for the PS3.
However, no release dates have been given at this time.
To quote: "The ESRB site doesn't have the search fields in the URL so we can't give you links to the ratings for the games, but search for them and you'll see the newly added 'PlayStation 3' platform under each one.
No dates yet, of course, but presumably we'll see these on our Store sooner rather than later."
More PlayStation 3 News...


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Stealth Cam Unit Ops Black Flash Infared Game Camera 8.0 Megapixel Black
Product #: 182995 Stealth Cam #: STC-U840IRNG UPC #: 813628084310
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If you've ever run game cameras, does the following scenario sound at all familiar to you? Upon reviewing your pictures, you get a nighttime picture of a big buck, never to see him again on camera. Was catching this buck on camera just a fluke or more importantly, did the flash from your incandescent or glow for your normal infrared camera spook him? Cast all doubt aside with the Stealth Cam Unit Ops game camera. This compact camera features "No Glo" black flash technology, for undetectable image taking. Deer can go about their normal business in front of your camera and be none the wiser that they are now on your watch list. Stop worrying about whether your cameras are spooking your deer and spend more time devising a plan to put that big buck on your wall this fall.
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SPECIAL REPORT: Canonization coverage from Rome | WATCH TONIGHT @ 11
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Printed on: Apr 24, 2014
Final Sale
Striped Layering Top
Item# 4224155
Sorry, this item is no longer available!
- Silky striped crepe de chine
- Horizontal striped front, vertical striped back
- Scoopneck
- Shaping darts
- Cap sleeves
- Curved hem
- 100% Polyester
- Machine wash.
- Imported
Dressy look Great silky top. Looks great with pants on its own or with a sweater or suit. August 30, 2013
Cute shirt The shirt fits well - it has a loose fit and goes well with skinny jeans. I agree with other reviews though, that I would prefer the print to be horizontal stripes all the way around. Overall it is a cute shirt though! June 27, 2013
Cute top - not sure on print I love the way this top fits, it's comfortable, stylish and can be dressed up or down. But I'm not sold on the stripes in the back...wish they were horizontal all the way around, not vertical like a referee. June 26, 2013
Great Shirt I purchased this shirt in the off white and tan. I love the colors and its a great loose fitting shirt. June 24, 2013
Love it I have this top in the khaki and white and absolutely love it. It's a great summer top and looks great with white skinny pants for a nautical look. Fit and quality are great. I highly recommend you buy this top if you are thinking about it before it sells out. June 23, 2013
Perfect blouse love this blouse. I ordered the cream and orange stripes. As usually I ordered the XS since limited tops tend to run a little big on my petite body. Also, no need to wear a cami under this blouse. The material is solid and not cheer (which I appreciate since it seems that most retailers only offer sheer options now). June 22, 2013
Ok Top Top is great for running errands and price wasn't too bad either. June 21, 2013
Amazing I love the flow of this. Looks great under a suit jacket if you want a more casual office look, but it goes really well with jeans, too. June 21, 2013


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How much do you know about the era of Prohibition, when gangsters rose to power and bathtub gin became a staple? 2013 marks the 80th anniversary of the repeal of the wildly unpopular 18th Amendment, initiated on 17 February 1933 when the Blaine Act passed the United States Senate. To celebrate, test your knowledge with this quiz below, filled with tidbits of 1920s trivia gleaned from The Oxford Encyclopedia of Food and Drink in America: Second Edition.
Your Score:
Your Ranking:
The second edition of The Oxford Encyclopedia of Food and Drink in America thoroughly updates the original, award-winning title, while capturing the shifting American perspective on food and ensuring that this title is the most authoritative, current reference work on American cuisine. Editor Andrew F. Smith teaches culinary hist ory and professional food writing at The New School University in Manhattan. He serves as a consultant to several food television productions (airing on the History Channel and the Food Network), and is the General Editor for the University of Illinois Press' Food Series. He has written several books on food, including The Tomato in America, Pure Ketchup, and Popped Culture: A Social History of Popcorn in America. The Oxford Encyclopedia of Food and Drink is also available on Oxford Reference.
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The post A quiz on Prohibition appeared first on OUPblog.


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• Largest, oldest private research university on the West Coast
Nationally ranked bachelors, masters and doctoral degree programs
• More international students than any other U.S. school (8,000+)
• Located near downtown Los Angeles, close to beaches, mountains, shopping
Check out the *NEW* USC Language Academy Guidebook!
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• Highest quality, full-time, professional faculty
• 21 instructional hours on campus each week
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• Short-term Study Tour and Group Programs year round
• Courses taught on campus with university faculty
• Housing and meal arrangements available
• Full-service programs for 12-40 participants
• For more information, contact Madeleine Mejia at email@example.com or visit the Professional Development website.
USC Language Academy
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Telephone: 213-740-0080 • Fax: 213-740-0088
Questions? Email firstname.lastname@example.com


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Thursday, April 24, 2014
By Deirdre Fleming firstname.lastname@example.com
Staff Writer
Bear hunters in Maine again find themselves in the sights of animal-welfare advocates who contend that some of their practices are inhumane.
A black bear walks past an empty bait barrel in the Moose River Valley of the Jackman area of Maine during the 2010 hunting season. Bait barrels hold trail mix made of raisins, dried fruit and nuts, granola and doughnuts, said Steve Beckwith, a longtime Maine hunter and hunting guide. Opponents of bear baiting are seeking to ban the practice, saying it's cruel and gives hunters an unfair advantage.
Courtesy of mainehunters.com
Less than 10 years after Maine residents voted down a divisive referendum effort to abolish the use of bear hunting with bait, dogs and traps, the debate has re-emerged.
As hunters prepare for the first day of bear season Monday, sportsmen, politicians and animal-rights advocates are gearing up for a renewal of the referendum battle that spiked passions on both sides in 2004.
Bear-baiting involves placing food in the same location repeatedly for about a month before the season opens in hopes a bear will get in the habit of visiting the site regularly. Hunters also use dogs wearing radio collars to force a bear up a tree and keep it there until the hunter tracks it down electronically. Traps such as wire foothold snares are also used to hunt bears.
Supporters of banning the practices say they are cruel and give hunters an unfair advantage.
Opponents argue that the practices are vital to keeping the state's bear population in check. If they are banned, the population will explode, and conflicts between bears and people will become commonplace, even in developed areas, they say.
Maine has one of the largest black bear populations in the lower 48 states, according to the Department of Inland Fisheries and Wildlife, and is the only state to allow all three controversial practices.
A coalition led by the Maine chapter of the Humane Society of the United States, called Mainers For Fair Bear Hunting, is behind the ballot initiative. It aims to collect as many as 80,000 signatures next month to get a referendum question on the 2014 ballot. The Secretary of State's Office is still drafting language on the referendum question.
In 2004, voters rejected the referendum question seeking a ban on the three hunting practices by a margin of 53 percent to 47 percent. Each side spent more than $1 million on the campaign.
Those backing a ban on the practices said last week they think they'll win this time.
"This is a last resort (after trying several times without success in the Legislature). But with the additional 10 years of experience, we're confident we can win on the ballot," said Katie Hansberry, director of the Maine chapter of the Humane Society.
Maine hunters expected the issue to resurface, and that it would involve another expensive ballot fight.
"I think we knew they'd be back," said David Trahan, director of the Sportsman's Alliance of Maine. "(The Humane Society is) a nationwide group. And (it) raises a lot of money."
Proponents say the three controversial bear-hunting methods give hunters an unfair advantage and that trapping or shooting a bear over bait is inherently cruel.
Maine is a focal point in the debate over bear-hunting practices because it is the only state where all three are allowed.
Robert Fisk, director of the Maine Friends of Animals, which led the 2004 effort to ban the hunting practices, said the public is more familiar with the issues today, and that gives ban supporters an advantage.
"I believe we have an excellent chance of winning this time. The opposition's alarmist strategies and scare tactics that were prevalent in 2004 can be exposed this time around. People are much more aware of animal protection issues than they were 10 years ago," Fisk said.
Proponents say they have data and experiences from other states where the Humane Society successfully banned the use of these bear hunting methods, and that much of the Maine public was educated on the issue in 2004.
(Continued on page 2)
click image to enlarge
These three photographs of a black bear at a bait bucket were captured by a hunter's trail camera in 2008. Maine hunters and guides call the practice an efficient way to bag bears in a densely forested state.
Photos courtesy Days Bear Bait in Alfred
click image to enlarge
click image to enlarge
click image to enlarge
A black bear nibbles on some meat near Greenville. A coalition led by the Maine chapter of the Humane Society of the United States aims to collect as many as 80,000 signatures next month to get a referendum question on bear-hunting practices on Maine's 2014 ballot.
1998 file photo/The Associated Press
click image to enlarge
Katie Hansberry of the Maine chapter of the Humane Society hands out pamphlets at the farmers market in Portland's Deering Oaks park Saturday. Animal-welfare advocates want to ban three bear-hunting methods: baiting; using dogs; and using snare traps.
Gordon Chibroski/Staff Photographer


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Items where Author is "McInnes, M"
Group by: Item Type | No Grouping
Number of items: 1.
Leith, JQ and McInnes, M (2011) Co-working, exploring the ways teacher-practitioners shape students' learning experience in fashion and textiles higher education. In: UKADIA (United Kingdom Arts and Design Institutions' Association) 2011 Conference , 8 February 2011, Sadler's Wells, London. (Unpublished)


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Condors Remember Their Fallen Teammate, Leader Jeremy Williams; SoCal Coach Marco Ruas Battles Seattle Coach Maurice Smith in Bonus Superfight
NEW YORK, June 20, 2007- The International Fight League (OTC.BB: IFLI), the worlds number one professional mixed martial arts league, goes inside the bout between the Southern California Condors and San Jose Razorclaws, in the next episode of IFL Battleground on Monday, June 25, at 8 p.m. ET/PT (7 p.m. CT/MT). The bout was held in the wake of the tragic death of the Condors Jeremy Williams; the episode features an extended tribute to the star middleweight. IFL Battleground airs every Monday night on MyNetworkTV.
Among the six full bouts in Mondays episode is the matchup between MMA legends and current IFL coaches Marco Ruas of the Condors and Maurice Smith of the Seattle Tiger Sharks. Ruas squad was also fighting a playoff berth as it took on Frank Shamrocks Razorclaws at the packed Sears Centre in Chicago.
Additionally, the search for the next IFL Ring Girls continues, with audition footage of some contenders and a few pretenders from searches conducted in New York and Los Angeles.
Some of the matchups seen in the episode include:
Justin Levens (Philadelphia), one of Williams closest friends, who stepped in at middleweight, vs. the Razorclaws tough former Marine Brian Foster (Moreno Valley, Calif.) Adam Lynn (Pittsburgh) of the Condors vs. Josh Odom (Tallahassee, Fla.) in a battle between two other former Marines Unbeaten Antoine Jaoude (Rio de Janeiro, Brazil) faces a tall order in veteran MMA heavyweight Dan Christison (Las Vegas), making his second appearance for the Razorclaws Marcos nephew, Rodrigo Ruas (Rio de Janeiro, Brazil) looking for his first IFL win against welterweight Donnie Liles (Colorado Springs, Colo.)
Viewers can find their local MyNetworkTV affiliate at www.mynetworktv.com/local_stations.html.
The episode is the 12th in the IFL Battleground series, which has recently been renewed for the Fall 2007 MyNetworkTV lineup.


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These questions and answers address a number of questions that have been brought to the attention of the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have been developed and are maintained by the QWP.
They provide the EEA's harmonised position on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures.
If a question is not addressed, marketing-authorisation holders are encouraged to contact the European Medicines Agency for further information at firstname.lastname@example.com.
These questions have been produced to provide clarification or additional information, and should be read in conjunction with the European Pharmacopoeia, quality guidelines and other guidance documents.
- H: applicable to medicinal products for human use
- V: applicable to veterinary medicinal products
Table of contents
- Appearance of tablets of different strengths
- Definition of 'active substance' in relation to mixtures
- Packaging
- Reduced testing of starting materials
- Setting specifications for impurities in veterinary medicinal products
- Specific type of products – Dry product inhalers
- Specific types of product - Graduation of measuring devices for liquid dosage forms
- Specific types of product - Need for in vitro dissolution studies with alcohol for modified-release oral products including opioid drug products
- Specific types of product - Quality of investigational medicinal products
- Specific types of product - Veterinary medicinal products
- Stability - Article-58 products
- Stability - Declaration of storage conditions
- Stability - Endotoxin testing and sterility testing at the end of shelf-life
- Stability - Reduced design in stability studies
- Stability - Stability issues of pharmaceutical bulk products use in manufacture of the finished product
- Storage
- Water
Appearance of tablets of different strengths
- 1. If the applicant wishes to apply for more than one tablet strength, what level of difference in the appearance between the different tablet strengths would be required? H+V June 2011
In the case of applications for more than one tablet strength, the different tablet strengths should be distinguishable at a level sufficient to avoid mistakes between the different strengths by the final user. Distinguishing tablet strengths by colour / shape and marking / embossing is preferable.
Definition of 'active substance' in relation to mixtures
- 1. In case more than one active substance produced at different manufacturing sites is mixed together at a different manufacturing site, is it possible to consider the mixing as active substance manufacture? H+V June 2011
No. The mixing of active substances that can exist and are produced on their own should be considered as the first step of the manufacture of the finished product.
It should be noted that the definition of active substance given in part II of the European Union (EU) good-manufacturing-practice (GMP) guide (active substances) states that an active substance is a substance or a 'mixture of substances', but this definition takes into account cases when active substances are not single chemically defined substances (e.g. herbal extracts) and it is not meant to allow a mixture of chemically defined active substances to be considered as a single active substance.
As a consequence of what is stated above, the mixing of active substances is subject to compliance with part I of the EU GMP Guide (finished products) and it is not possible to present a single active substance master file for the mixture.
- 1. No specific requirements or recommendations are provided in the European Union guideline on plastic immediate packaging materials, CPMP/QWP/4359/03 and EMEA/CVMP/205/04, in regard to acceptable quality standards for plastic materials to be used for containers for solid oral dosage forms and solid active substances. Should the materials always comply with the specifications in the European Pharmacopoiea and if not, which quality standards are considered to be acceptable? H+V January 2009
The chapters of the European Pharmacopoeia (Ph. Eur.) that describe materials and containers are not exhaustive with regard to all different types of plastic materials and additives. Reference to the specifications published in the Ph. Eur. is therefore not always possible. As outlined in the Ph. Eur. general notices 1.3, it is not obligatory that only materials complying with a given specification in a chapter of the Ph. Eur. can be used as immediate packaging materials. Materials with a different formulation, complying with a different specification may be used, if justified, and subject to agreement by the competent authority.
For solid oral dosage forms and solid active substances, it has been agreed by the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party that plastic materials compliant with the relevant European Union (EU) food legislation relating to plastic materials and articles intended to come into contact with foodstuffs are considered acceptable. A specification elaborated in accordance with the provisions described in the EU guideline on plastic immediate packaging materials (CPMP/QWP/4359/03) should be laid down.
- 2. Does the European Medicines Agency / Committee for Medicinal Products for Veterinary Use guideline on development pharmaceutics for veterinary medicinal products and its annex decision trees for the selection of sterilisation methods prevent the use of heat-labile plastic packaging materials and aseptic processing for sterile veterinary medicinal products? V February 2012
Ensuring the sterility of medicinal products is the main issue when considering the packaging for sterile products, and therefore the method of choice for the production of any sterile products should be terminal sterilisation.
The European Medicines Agency / Committee for Medicinal Products for Veterinary Use guideline on development pharmaceutics for veterinary medicinal products and its annex decision trees for the selection of sterilisation methods currently state in the introduction to the annex that, "the use of an inappropriate heat-labile packaging material cannot in itself be the sole reason for adoption of aseptic processing. Manufacturers should choose the best sterilisation method achievable for a given formulation and select the packaging material for the product accordingly. However, it may be that the choice of a packaging material for a given product has to take into account factors other than the method of sterilisation. In such cases these other factors need to be clearly documented, explained and scientifically justified in the marketing authorisation dossier."
Aseptic processing cannot be considered as a simple replacement for terminal sterilisation. The European Pharmacopoeia (Ph. Eur.) general text 5.1.1: methods of preparation of sterile products states that, "wherever possible, a process in which the product is sterilised in its final container (terminal sterilisation) is chosen," and that, "if terminal sterilisation is not possible, filtration through a bacteria-retentive filter or aseptic processing is used; wherever possible, appropriate additional treatment of the product (for example, heating of the product) in its final container is applied." Such a combination of aseptic processing with non-standard lower temperature heat treatments, either before aseptic filling, or after aseptic filling, should be pursued where possible in line with the recommendations of the Ph. Eur.
The guideline therefore does not prevent the use of heat-labile packaging materials for sterile products, but there must be justified reasons for having such packaging for sterile products, and these must be supported by the overall benefit:risk balance of the product.
Reduced testing of starting materials
- 1. What information should be included in marketing-authorisation dossiers regarding the actual testing that is carried out on any starting materials, e.g. active substances, excipients and packaging materials, on receipt by a finished product manufacturer? H+V June 2011
Although some parameters should always be tested on receipt by the finished product manufacturer e.g. diethylene glycol in glycerol, what is actually tested on receipt is fully covered under good manufacturing practice and should be justified based upon risk assessments, based on historical data backed by supplier audit. Consequently, the relevant registered specifications in the marketing-authorisation application should not include any reference at all to reduced testing on receipt by the finished product manufacturer.
Setting specifications for impurities in veterinary medicinal products
- 1. Different positions regarding the setting of specifications for both single identified and unidentified impurities observed below 1.0% in the finished product specifications (release and shelf-life), in veterinary medicinal products, appear to have arisen from the wording of VICH Guidelines GL11 and GL39 (mainly decision tree 2) being interpreted in two different ways. What limits should therefore be applied for impurities in veterinary medicinal products? Should these limits be set to < 1.0% (the VICH guideline GL11 identification threshold limits) regardless of the batch analyses and stability study data? Or should they be set based on the results observed in the batch analyses and stability studies? V July 2013
Individual impurities:
- the limits for individual impurities can be set by applying the VICH GL11 identification/qualification threshold of 1.0% (for impurities for which there are no specific safety concerns) irrespective of batch data results. Lower limits for individual impurities (e.g., 0.4%) are however also acceptable if proposed by the applicant and supported by batch data.It should be noted however, that individual impurities observed at levels greater than 0.3% should be reported, in accordance with VICH GL11.
Total impurities:
- the limits for total impurities should be based on batch results, nevertheless where limits of 1.0% have been accepted for individual impurities, a limit for total impurities of less than 1.0% should not be requested by competent authorities, irrespective of the batch data results.
Specific type of products – Dry product inhalers
- 1. Should dropping of an inhalation device be investigated during development? H June 2012
Dropping of the device should be investigated as part of the robustness study defined in the guideline on the pharmaceutical quality of inhalation and nasal products (section 4.2.18).
The product performance should be investigated under conditions to simulate use by patients.
The delivery device should be carried between use and actuated at the frequency indicated in the instructions for use. Simulation of dropping the delivery device and the robustness of any lockout mechanism should be investigated. The dropping simulation should be performed towards the end of the life of the product (e.g. at dose 180 for a 200-dose product) in order to assess the effect of drug accumulated on the mouthpiece, or any other part of the device, during the lifetime of the device being dislodged. If the device is designed to have the mouthpiece removed for periodical cleaning, testing should be performed both with the mouthpiece removed and cleaned in accordance with instructions for use during the test, and, as a worst case, without removal and cleaning. Significant variations in the delivered dose and/or fine particle mass should be fully discussed in terms of the safety and efficacy of the product. Appropriate handling instructions to the patients should be established, based on the results obtained.
Specific types of product - Graduation of measuring devices for liquid dosage forms
- 1. What are the requirements for the graduation of measuring devices for liquid dosage forms of medicinal products for human use, in particular in relation to the suitability of the graduation of the measuring device regarding dosing accuracy and dosing precision of the related product and the suitability of the measuring device for the related product? H September 2006
The points discussed below are applicable to new marketing-authorisation applications or fully reformulated existing medicinal products. These points should be considered referring to the graduation of a measuring device for a liquid dosage form of a medicinal product for human use, such as solutions, suspensions and emulsions, in section 3.2.P.2: pharmaceutical development of the Common Technical Document. They should be part of the justification of the suitability of the graduation of the measuring device for dosing the medicinal product under application. The measuring device shall comply as well with the relevant parts of the requirements given in the Medical Device Directive 93/42/EEC and with International Organization for Standardization (ISO) standards, as applicable.
Measuring devices may be required to deliver oral, parenteral, nasal, vaginal, and rectal liquid dosage forms to patients. The measuring device can be marketed together with the medicinal product, e.g. syringes without needles to administer oral liquid preparations, measuring cups, spoons or beakers, pipette applicators, or can be incorporated as integral part of the medicinal product, e.g. prefilled syringes.
Manner of graduation: The graduation should be applied to the measuring device in such a manner that accurate and precise dosing is guaranteed. The graduation can be embossed in the material. The graduation can also be printed on the material of the measuring device.
This precision and accuracy of dosing should be guaranteed from release throughout storage until the end of shelf life and also during the use of the particular measuring device under the conditions recommended in the summary of product characteristics (SmPC). Attention should be paid to the possibility of fading of the printing ink. Glueing of a label with a printed graduation to the measuring device is not generally favoured, because of the potential for dislocation of the glued label during storage and use. If a glued label is used, the effectiveness of the adhesive / label system under normal conditions of storage and use should be demonstrated.
Graduated scale: The graduated scale should correspond with the dosing advice as stated in section 4.2: posology and method of administration of the SmPC. This applies in principle to all measuring devices. Attention should among others be paid to the following items:
- possibility of the measuring device to supply the minimal and maximal dose per single dose (nominal capacity);
- suitability of the scale intervals in relation to the dosing advice or the dosage range when posology is stated per kilogram bodyweight or square metre body surface;
- ease of interpretation of the graduated scale: readability of the graduation numbers and the graduation lines, and distinction between the intervals of the scale.
European or international standards (European Committee for Standardization or ISO) may be available, e.g. for syringes recommendations are given on tolerances, graduated capacity, and graduated scale in ISO standards. These recommendations can be applied without further justification.
Suitability of measuring device for the medicinal product: The suitability of the measuring device for the medicinal product should be addressed. Attention should be paid to the following items:
- dosing accuracy and precision in relation to the therapeutic window of the drug substance;
- the risk of overdosing in relation to the measuring device. If possible, overdosing should be prevented. If the risk of overdosing cannot be avoided, appropriate care should be taken in the design of the scale graduation to prevent overdosing;
- the physical characteristics of the liquid in relation to the measuring device. The combination should assure accurate and precise dosing. Considerations can be for instance the needle diameter and the particle size of suspensions in injectables, the homogeneity (resuspendability) of suspensions and emulsions prior to and during the application of the measuring device, or residual amounts of liquid in the measuring device after administration of the dose to the patient.
Furthermore, suitability of the measuring device and its graduation for the intended patient population should also be taken into account.
Acceptance criteria: The graduation of the measuring device should be suitable to meet the acceptance criteria of the dose of medicinal product under application, as measured with the measuring device under application. These acceptance criteria should be in line with European Pharmacopoeia (Ph. Eur.) requirements, if applicable (for example Ph. Eur. 2.9.27: uniformity of mass of delivered doses from multidose containers), or other accepted pharmacopoeias. For single-dose containers, where not necessarily the whole content of the product needs to be administered to the patient, the same requirements can be applied as for multidose containers.
Specific types of product - Need for in vitro dissolution studies with alcohol for modified-release oral products including opioid drug products
- 1. What are the likely implications of the various observed in vitro effects of alcohol on the dissolution of different prolonged release opioid products at various concentrations and durations of exposure? H April 2009
In the absence of clinical data, the results of in vitro observations with alcohol (ethanol) may be considered, as a minimum, evidence of a possible physicochemical incompatibility with alcoholic drinks. The possibility of such an incompatibility with alcoholic drinks should be considered for all modified release products.
The general methods of in vitro release testing are considered capable of providing sufficient evidence of alcohol incompatibility. In the case where in vitro alcohol incompatibility of the drug product is demonstrated, then appropriate warnings should be included in the summary of product characteristics, in line with current guidelines.
- 2. Is it considered that in future, in vitro studies investigating the effect of alcohol / ethanol on dissolution / release should be required for the following cases? H April 2009
The interaction with alcohol observed in vitro should be considered as a physicochemical incompatibility of the drug product. In line with current regulatory practice, reference to this incompatibility, albeit dietary rather than medicinal, has been included in the product literature to supplement the current pharmacological warning to avoid alcohol.
In vitro studies investigating the effect of alcohol / ethanol on dissolution / release are recommended for all opioid modified-release products where applicants consider the potential for incompatibility with alcohol exists.
To minimise the risk, it is recommended that the product design, if possible and practical, should be such that a physicochemical incompatibility with alcohol is avoided. This advice is especially important for drug substances with a narrow therapeutic index.
- 3. Is it considered that in vitro studies investigating the effect of alcohol / ethanol on dissolution / release might also be required for oral prolonged release formulations containing active substances other than opioids? If so, should they be required only where rapid dose dumping of the active substance might be expected to cause clinically hazardous overdose, or should they be required for all oral prolonged-release products containing any active substance? H April 2009
Where there are scientific grounds that the defined-release characteristics of the oral drug may be adversely affected by the presence of alcohol, then alcohol physicochemical incompatibility should be considered by the applicant. This would apply to all oral prolonged- (and delayed- and modified-) release products.
- 4. How might the methodological requirements for in vitro testing of the potential for accelerated release in the presence of alcohol be established, ensuring maximum relevance to the clinical situation? H April 2009
At this point in time, it is not possible to provide authoritative methodological requirements.
In vitro studies are considered sufficient to show evidence of alcohol incompatibility, with a consequential effect on the quality of the drug product, with respect to release performance.
It is noted that in vitro release testing primarily relates to the quality control of drug products, with limits set to be in line with those batches used for clinical studies for which satisfactory safety and efficacy has been established.
Taking this into account, if the presence of alcohol in the dissolution medium of the in vitro release test produces out of specification results, then this may be considered sufficient evidence of an incompatibility with alcohol, i.e. that alcohol adversely affects the quality of the drug product.
In the first instance, the applicant should consider the possibility of physicochemical incompatibility with alcohol. This should include a discussion of the solubility of the release controlling excipients in alcohol and the impact this may have on the in vitro release performance of the drug product. Where solubility or other information cannot exclude the possibility of physicochemical incompatibility with alcohol, then in vitro release data should also be provided to assess the extent of interaction.
The dissolution medium should be the same as that proposed for routine testing, but with a justified range of alcohol added. The range of alcohol in the medium should mimic levels that are likely to be reached in the fluid of the stomach and proximal gastrointestinal tract following alcohol consumption e.g. 5%, 10% and 20%.
The applicant should discuss the significance of any out of specification results, particularly at the early time points, together with consideration of the risks of dose dumping and accelerated release. Appropriate warnings in the summary of product characteristics should be proposed and justified.
- 5. Are further measures needed to gain better understanding of the release characteristics of oral prolonged-release products in the presence of alcohol and their relevance to the clinical situation, for example by in vitro – in vivo correlation? If in vitro testing demonstrates a potential for alcohol to enhance opioid / active product release, should the applicant be required to investigate the clinical relevance of the effect in in vivo studies? H April 2009
It should be acknowledged that the clinical relevance of physicochemical incompatibility with co-administered alcohol is debatable, at the present time. The published literature is limited.
Where incompatibility with alcohol is evident, it is currently sufficient to address safety or other concerns by the inclusion of appropriate warnings in the product literature unless serious concerns are raised with respect to efficacy and safety.
Specific types of product - Quality of investigational medicinal products
- 1. Setting specifications for impurities (2.2.1.S.4.1, 2.2.1.S.4.5, 2.2.1.P.5.1 and 2.2.1.P.5.6): On which basis should specifications for related impurities be set? H January 2011
Reference to relevant paragraphs of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (CHMP/QWP/185401/2004) is given for each question.
Safety considerations should be taken into account. The limits should be supported by the impurity profiles of batches of active substance used in non-clinical and clinical studies. Results between batches should be consistent (or the clinical batches should show better purity results than non-clinical and previous clinical batches).
Compliance with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) requirements is not required, if proper justification is provided.
Where specifications are set for potential genotoxic impurities, the guidance given in questions and answers on the guideline on limits of genotoxic impurities (EMEA/CHMP/SWP/431994/2007) should be taken into consideration (question 6: staged threshold-of-toxicological-concern approach).
- 2. Substantial amendments (chapter 8): How should industry notify amendments? January 2011 (corrected November 2011)
Reference to relevant paragraphs of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (CHMP/QWP/185401/2004) is given for each question.
The table in the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (CHMP/QWP/185401/2004) gives examples of what should be notified as substantial amendments and of changes where a notification will not be necessary. The list is not exhaustive, and the sponsor should decide on a case-by-case basis if an amendment is to be classified as substantial or not.
For non-substantial amendments documentation should not be proactively submitted, but the relevant internal and study documentation supporting the change should be recorded within the company and if appropriate, at the investigator site. At the time of an overall investigational medicinal product dossier update or submission of a substantial amendment the non-substantial changes can be incorporated into the updated documentation. There is no need to use the notification of amendment form for these changes.
- 3. Shelf-life extensions (2.2.1.P.8 and chapter 8): What information should be included in the file in order to make shelf-life extensions without notification of a substantial amendment? H January 2009
Reference to relevant paragraphs of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (CHMP/QWP/185401/2004) is given for each question.
The criteria based on which it is intended to extend shelf life during an ongoing study should be given. The information should include extension protocol limiting the maximum time period for extrapolation. In the case of any significant negative trend for stability data observed during long-term and accelerated testing, the sponsor should commit to notify any shelf-life extension as a substantial amendment.
- 4. Batch data (2.2.1.S.4.4 and 2.2.1.P.5.4): Are certificates of analysis needed? H January 2009
Reference to relevant paragraphs of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (CHMP/QWP/185401/2004) is given for each question.
No, tabulated batch results are sufficient. Data for representative batches should be included in the batch analysis table of the investigational medicinal product dossier. Results for batches controlled according to previous, wider specifications are acceptable if the results comply with the specification for the planned clinical trial. The results should cover the relevant strengths, but the batches do not need to be the same that will be used in the clinical trial.
- 5. Drug substance and drug product batch data for proposed manufacturing sites: Are drug substance and drug product batch data for all proposed manufacturing sites listed in S.2.1/P.3.1 required to be submitted in the investigational medicinal product dossier, or provided as a substantial amendment prior to use in a study? H January 2011 (corrected November 2011)
Reference to relevant paragraphs of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (CHMP/QWP/185401/2004) is given for each question.
Data from representative batches should be provided. This implies that data should be provided for each proposed site. However, where one legal entity has multiple sites (in the same country), then batch data from one site only would be sufficient.
For non-substantial amendments documentation should not be proactively submitted, but the relevant internal and study documentation supporting the change should be recorded within the company and if appropriate, at the investigator site. At the time of an overall investigational medicinal product dossier update or submission of a substantial amendment the non-substantial changes can be incorporated into the updated documentation. There is no need to use the notification of amendment form for these changes.
Specific types of product - Veterinary medicinal products
- 1. What limits for microbiological quality are considered appropriate for premixes for medicated feeding stuffs which contain excipients of natural origin (e.g. soya bean husks, maize meal, etc.)? V January 2014
Ideally, compendial grade excipients should be used in new veterinary medicinal products.
Premixes for medicated feeding stuffs should comply with the requirements of the European Pharmacopeia (Ph. Eur.) general chapter 5.1.4: microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use. It is expected that these products comply with the requirements for non-aqueous preparations for oral use.
If it is not possible to comply with these limits, premixes containing excipients of natural (animal, vegetal or mineral) origin should comply with the requirements of "Special Ph. Eur. provision for oral dosage forms containing raw materials of natural (animal, vegetal or mineral) origin for which antimicrobial pretreatment is not feasible and for which the competent authority accepts…….".
However, if justification is provided that these limits cannot be met, then the requirements of the "Special Ph. Eur. provision for premixes for medicated feeding stuffs for veterinary use using excipients of plant origin for which antimicrobial treatment is not feasible." are applicable.
In cases where an oral powder and a premix for medicated feedingstuffs have the identical composition, it would be expected that the same microbiological limits would be applied to both pharmaceutical forms. In this case the stricter limits are applicable (normally those for oral powders requested in chapter 5.1.4: non-aqueous preparations for oral use).
- 2. Is it possible to grant a marketing authorisation for a product which is not soluble over the pH ranges described in the guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water (EMEA/CVMP/540/03 Rev.1)? Could a recommendation be added in the summary of product characteristic / product information that, for solubility reasons, the pH of the drinking water has to be adjusted with acid / base before adding medicinal product? V October 2010
The guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water (EMEA/CVMP/540/03-Rev.1) sets out how the solubility of a product in drinking water should be tested (soft water / low pH with a pH range from 5.0 to 7.0 and hard water / high pH with a pH range from 8.0 to 9.0).
In principle, a veterinary medicinal product can only be authorised if it fully dissolves (and remains in solution) without further aid in drinking water of the usual pH range (which is usually a pH range between 5.0 and 9.0). If a pH adjustment of the drinking water is necessary this should be done with excipients (acid, base or buffer) included as part of the authorised veterinary medicinal product. Exclusions are only acceptable if justified (e.g. it has been shown that other formulation principles have been excluded).
The use of unlicensed acids or alkalis for the pH adjustment of the drinking water before (or after) adding the veterinary medicinal product in order to achieve the necessary solubility is not acceptable unless justified.
- 3. Is it permitted to have a multidose (parenteral) veterinary medicinal product for use both as an intramuscular injection and also an intramammary preparation? V October 2010
Such an example would be considered to be two different pharmaceutical forms (and also in this specific problem case, routes of administration) and therefore to need two different marketing authorisation (sub)numbers, as well as two different summaries of product characteristics.
In the European Union, different marketing authorisations (sub)numbers are necessary for different pharmaceutical forms. See the guideline on the categorisation of new applications versus variation applications.
Another reason is that using multidose containers for both intramammary and parenteral use may result in an increased risk of microbial contamination of the product in its multidose container.
- 4. Rubber stoppers (bungs) used for vial closures for multidose veterinary injectables are often punctured many times during use. Therefore suitable criteria regarding fragmentation (and self-sealing) are required. Problems can mainly arise in large multidose injectables, which can be used for different target species and / or ages of animals, but particularly for smaller animals where dose volumes are small, and so the pack could be punctured many times (e.g. in extreme cases in excess of 100 punctures). Should the general chapter on rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders (3.2.9) be applied in these cases? Which criteria for the maximum number of rubber fragments are deemed acceptable for a test design which is a multiple of the number of punctures described by Ph. Eur. 3.2.9? Should a worst-case scenario be used? V October 2010
The general chapter on rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders (3.2.9) is not mandatory on its own. If suitable justification is provided, the requirement (maximum of five fragments) contained in this chapter does not necessarily need to be applied. It is noteworthy that the European Pharmacopoeia (Ph. Eur.) test is designed to demonstrate that a stopper fulfills the general minimum requirements that are expected for rubber stoppers for medicinal products, but this can of course not cover all their potential uses.
The pack concerned should be proven to meet the requirements of the Ph. Eur. test modified to use the maximum number of punctures expected in relation to the target species, dose and route of administration (using the appropriate needle size for that scenario). Note that the maximum number of fragments expected remains exactly as in the Ph. Eur. test.
The summary of product characteristics (SmPC) and other product information should then reflect the number of punctures for which the closure has been demonstrated to meet the requirements of the Ph. Eur. test. For example, if the closure has been shown capable of withstanding X punctures with fragmentation and self-sealing characteristics which meet the relevant Ph. Eur. requirements. That is, with no additional increase in fragments for the increased number of punctures.
Risk-management tools
Some examples of advice (if necessary in combination) which could be included in the SmPC (section 4.9) and other product literature to reduce potential damage to the stopper from excessive numbers of punctures:
- "The cap may be safely punctured up to X times."
- "When treating groups of animals in one run, use a draw-off needle that has been placed in the vial stopper to avoid excess broaching of the stopper. The draw-off needle should be removed after treatment."
- "Only the xx ml vial should be used to treat small piglets."
- "As the vial should not be broached more than X times the user should select the most appropriate vial size according to the target species to be treated."
- "When treating large groups of animals use only an automatic dosing device (with vented draw off apparatus when using the xx ml vial)."
- "For xxx pack sizes, use only automatic syringe equipment." (Applicable for large collapsible packs where a large number of doses may be withdrawn from the vial and concern about the stopper integrity exist.)
- "For xxx pack sizes, use of a multiple dose syringe is recommended." (Applicable for large non-collapsible packs where a large number of doses may be withdrawn from the vial and concern about the stopper integrity exist.)
Stability - Article-58 products
- 1. What kind of stability data are required for applications according to Article 58 of Regulation EC/726/2004? H July 2006
Article 58 of Regulation (EC) 726/2004 widens the scope of the European Medicines Agency and the Committee for Medicinal Products for Human Use to include applications for certain medicinal products intended exclusively for markets outside the Community, e.g. for antiretroviral therapy:
"1. The Agency may give a scientific opinion, in the context of cooperation with the World Health Organization, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Community. For this purpose, an application shall be submitted to the Agency in accordance with the provisions of Article 65. The Committee for Medicinal Products for Human Use may, after consulting the World Health Organization, draw up a scientific opinion in accordance with Articles 6 to 9. The provisions of Article 10 shall not apply."
For these applications, it is of great importance to apply standards that ensure the same adequate product quality as for products to be marketed in the European Union (EU). In this context, stability data need to be submitted by the applicant that demonstrate stability of the medicinal product throughout its intended shelf-life under the climatic conditions prevalent in the target countries, i.e. countries in climatic zones III and IV. Merely applying the same requirements as for the use in the EU, i.e. countries in climatic zone I / II, could potentially lead to substandard products when marketed in climatic zones III and IV.
The guideline stability data package for registration in climatic zones III and IV (ICH Q1 F) was officially withdrawn by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) steering committee in June 2006 due to controversial discussions about the adequacy of storage conditions defined. The World Health Organization (WHO) expert committee on specifications for pharmaceutical preparations has decided to split climatic zone IV into zone IVa (hot and humid) with storage conditions of 30°C/65% relative humidity (RH) and zone IVb (hot and extremely humid) with storage conditions of 30°C/75% RH; the WHO stability guideline will be revised accordingly.
When evaluating applications under Article 58 of Regulation EC/726/2004, it has to be assumed that the respective medicinal product will be used in all sub-zones of climatic zones III and IV, unless otherwise confirmed by the applicant. Therefore, in order to safeguard product quality throughout its entire intended shelf-life, stability studies under the conditions defined for climatic zones IVb need to be performed, i.e. the shelf-life needs to be established based on long-term data at 30°C/75% RH, supported by SIX months of data at 40°C/75% RH. The principles of extrapolation described in the note for guidance on evaluation of stability data (CPMP/ICH/420/02) as well as reduced testing designs as described in the note for guidance on bracketing and matrixing designs for stability testing of drug substances and drug products (CPMP/ICH/4104/00) may be applied. In cases where these data demonstrate stability over the required period of time, no special storage conditions need to be labelled.
If an application under Article 58 of Regulation EC/726/2004 only contains data adequate for climatic zones I / II, the list of questions should request the respective data appropriate for climatic zones III and IV. If the data show stability problems at 30°C/75% RH with regard to humidity, the circulation and use of the product should preferably be restricted to those countries and regions that are covered by data, e.g. the product should only be used in countries within climatic zones III and IVa. As an alternative, storage conditions need to be labelled, including humidity, e.g. 'keep protected from ambient humidity' as, especially for climatic zone IVb, humidity may be the stability-limiting factor.
However, it has to be noted that due to the technical equipment and logistics available in some of the climatic zone-IV countries as well as the education and compliance of patients in the respective area, exposure of medicinal products to higher temperatures and humidity cannot be ruled out. This needs to be taken into account when defining shelf-life and storage conditions. For products to be stored at 'normal conditions', i.e. stable at 30°C, submission of accelerated data, i.e. 40°C/75% RH, can not be waived as they are needed to assess the impact of extreme temperature or humidity conditions that may occur in climatic zone IV, even though a product may not be stable for six months at these storage conditions.
Please note that for aqueous products in semipermeable containers to be marketed in climatic zone III, i.e. regions of extreme temperature, long-term testing should be performed at 30°C/35% RH. As an alternative, the calculation factors described in section 18.104.22.168 'drug products packaged in semi-permeable containers' of the note for guidance on stability testing of new drug substances and products (CPMP/ICH/2736/99) may be applied.
Stability - Declaration of storage conditions
- 1. What is the declaration of storage conditions to be used in the product information, for products which require to be stored and transported refrigerated? H+V August 2007
As foreseen by the note for guidance on declaration of storage conditions, when a product needs to be stored refrigerated, the wording 'store in a refrigerator' should be used in the labelling, and a reference to the temperature range, e.g. 2°C to 8°C, should be included in the summary of product characteristics (SmPC) and in the package leaflet.
According to the same note for guidance, when the need for refrigerated transport (cool chain), in addition to refrigerated storage, is envisaged, the following statement should be used: 'store and transport refrigerated'.
- 2. How should expiry dates be calculated and expressed? H+V July 2008
Guidance can be found in the note for guidance on the start of shelf-life of the finished product (CPMP/QWP/072/96 / EMEA/CVMP/453/01) and the Committees for Mutual Recognition and Decentralised Procedures and Quality Review of Documents product information templates. In summary, the expiry date should be calculated from the date of release or in case the period between the date of production and the date of release exceeds 30 days, from the date of production. The expiry date should be expressed as MM/YYYY. The product expires at the end of the specified month.
In the worst case, this method of calculation results in an extension of the expiry date of two months:
Table 1: Example of the calculation of the expiry date of a tablet with a shelf life of 24 months
Date of first blending step Date of packaging Date of release Expiry date Interpretation fit for use Total time from start of manufacture to end of shelf-life Recalculated expiry date 28/01/2005 29/01/2005 30/01/2005 01/2007 Until 31 January 2007 2 years 3 days 01/2007 03/01/2005 04/01/2005 05/01/2005 01/2007 Until 31 January 2007 2 years 28 days 12/2006 03/01/2005 19/07/2005* 21/07/2005 01/2007 Until 31 January 2007 2 years 28 days 12/20061 03/01/2005 04/01/2005 01/02/2005 02/2007 Until 28 February 2007 2 years 56 days 01/20071
*The bulk compressed tablets have been stored for six months. It is expected that a shelf life for the intermediate product is detailed in the dossier and stability data to support this are also presented in the dossier.
Particularly for products with a shelf-life of less than twelve months, this is not considered acceptable. The expiry date should therefore be calculated on a DD/MM/YYYY basis starting from the date of release, or if applicable from the date of production, and rounded up or down to MM/YYYY according to the following example: 14/01/2007 becomes 12/2006 and 15/01/2007 becomes 01/2007. See table 1 for recalculated expiry dates.
1Note: This question and answer was first published in July 2008 with a mistake (the recalculated date for examples 3 and 4 were mixed-up). Later the mistake was identified by QWP and in March 2009 the present corrected version was published.
Stability - Endotoxin testing and sterility testing at the end of shelf-life
- 1. Is endotoxin testing considered essential at the end of shelf life to confirm parenterals to be pyrogen-free?
Endotoxin testing is not requested at the end of shelf life, taking into account the fact that it is not considered a stability-indicating parameter. The shelf-life specification should be completed with a footnote stating that endotoxins are not tested during stability studies.
- 2. Is sterility testing considered essential at the end of shelf life to confirm parenterals to be sterile? H+V May 2009
Sterility is part of the shelf-life specification.
Sterility testing should be performed at least at the end of shelf life but it can be replaced by testing of the container closure integrity. Depending on the nature of the container, intermittent integrity testing might be envisaged, independent of whether the sterility testing is replaced or not.
Stability - Reduced design in stability studies
- 1. Can reduced designs be used when performing stability studies on veterinary medicinal products? V October 2006
Yes, as long as the selected design is explained and justified. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline bracketing and matrixing designs for stability testing of drug substances and drug products (CPMP/ICH/4104/00), is applicable to new drug substances and products used in human medicine. However, veterinary companies may elect to follow this guideline. Where the guideline is followed, all aspects of the guideline should be followed.
Stability - Stability issues of pharmaceutical bulk products use in manufacture of the finished product
- Background
Finished product stability guidance does not address storage of bulk product during the manufacturing process. The purpose of these questions and answers is to address the information to be provided in the marketing-authorisation dossier to support storage and / or transportation of bulk product during the manufacturing process.
Good-manufacturing-practice guidance indicates that bulk products should be stored under 'appropriate conditions' and therefore, the data provided in the dossier should be aimed to demonstrate the suitability of these conditions in relation to the intended storage and / or transportation arrangements of a bulk product and the effect of these on the quality of the given finished product over its declared shelf-life.
The objective is to increase the transparency of the supporting data required and not to introduce any new regulatory requirements.
The data required will depend on the type of product and the activities performed (i.e. prolonged storage or transportation) and a risk-based approach is encouraged in order to demonstrate the suitability of the data generated in each individual case.
The described framework is intended to cover all pharmaceutical bulk products. However, it is understood that the requirements for some specific types of products (e.g. biological products) may require additional data relevant to the type of product and this should be taken into consideration depending on the characteristics of that particular product.
- 1. What is the definition of bulk storage? H+V February 2012
The question most frequently arises in relation to solid oral dosage forms (particularly tablet cores before coating or packaging) but could be applicable at any stage in the manufacturing process of any pharmaceutical product where bulk is held in storage prior to further processing (e.g. bulk solution prior to filling, granulates, etc.).
- 2. What information should be provided on the bulk container? H+V February 2012
In general, the level of information to be provided will be dependent on the nature of the bulk product. The qualitative and quantitative (if required) composition of the bulk container should be described in the dossier and its control specification stated (module 3.2.P.3.4 or part 2.B).
- 3. What information should be provided on the storage conditions? H+V February 2012
It should be stated whether the bulk product is to be stored (and if relevant, transported) under controlled or non-controlled storage conditions.
- 4. What information is necessary regarding the transportation of bulk products between manufacturing sites? H+V Feb 2012
Where bulk product is transported between manufacturing sites, the transportation arrangements should be described in general terms (bulk container / storage and transportation conditions / monitoring arrangements) in the dossier (module 3.2.P.3.4 or part 2.B).
According to the guideline on good distribution practice, the following should be taken into consideration:
- Good-manufacturing-practice quality should be maintained throughout the distribution network;
- Storage conditions should be observed at all times, including during transportation.
- Temperature should be monitored and recorded periodically;
- Records should be reviewed regularly.
- 5. What data should be provided to support bulk storage and transportation arrangements? H+V February 2012
The maximum storage interval for the bulk product should be declared in the marketing-authorisation dossier, or alternatively, the maximum batch manufacturing time from start of product manufacture to completion of packaging in the final primary container for marketing.
When storage is prolonged (i.e. more than 30 days for solid oral dosage forms; more than 24 hours for sterile products), evidence of the suitability of the proposed container, storage interval or transportation arrangements should be included in the dossier. The data to be provided will be dependent on results of development studies that represent the conditions proposed.
In line with the principles described for finished products in the relevant International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) or International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Products (VICH) guidelines, it is expected that data from pilot scale batches (minimum of two batches) stored under conditions that represent the storage conditions for the bulk product will be provided to support the storage of bulk products. Unless provided in the dossier, these data should be verified in post-approval stability commitments on commercial scale batches.
Where transportation of bulk between manufacturing sites is proposed, the impact of excursions outside of the original storage conditions should be discussed and, where necessary, supported by accelerated stability data.
- 6. How should the calculation of a product's shelf-life be performed? H+V February 2012
Calculation of the product's shelf-life should be in accordance with the Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use note for guidance on the start of shelf-life of the finished dosage form (CPMP/QWP/072/96 / EMEA/CVMP/453/01). If other methods are proposed, these should be declared and justified through inclusion of batches that represent the full proposed holding intervals of the bulk product (intermediate) in the finished product stability programme.
- 7. Which stability conditions should be chosen to support bulk storage? H+V Feb 2012
It is not necessary to conduct stability studies on bulk according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) or International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Products (VICH) recommendations (temperature or humidity). Stability studies on bulk should reflect real storage conditions in the standard container foreseen at the manufacturing site.
In the event that more than one manufacturing site is involved, the stability studies should also cover any transportation (duration and conditions).
- 1. What are the requirements for storage orientation recommendations in the product information for pressurised metered dose inhalers? H December 2008
During product development, the effect of orientation should be investigated in the priming and repriming studies according to the guideline on the pharmaceutical quality of inhalation and nasal products (EMEA/CHMP/QWP/49313/2005). If storage orientation has a significant effect on the delivered dose during these studies (i.e. different repriming periods / number of actuations are required for re-priming when stored in different orientations), a storage orientation recommendation should be added to the product information (summary of product characteristics, package leaflet and label). The preferred storage orientation should be detailed.
As it cannot be guaranteed that the product will always be stored in the preferred orientation, the repriming instructions in the product information should be based on the worst-case scenario (i.e. the orientation which requires the shortest repriming period or the highest number of repriming actuations).
- 1. What is the regulatory consequence of implementing an alternative method for rapid control of microbiological quality of water for injection and purified water? H+V July 2005
According to European Union legislation, pharmaceutical manufacturers are required to use European Pharmacopoeial standard water in the manufacture of medicinal products.
The European Pharmacopoeia (Ph. Eur.) has recently introduced a chapter making reference to the acceptability of rapid microbial methods to replace the standard Pharmacopoeial methods provided appropriate validation has been performed.
Following discussions at the QWP and the ad hoc good-manufacturing-practice inspectors' group, it is suggested that the introduction of such methods might require specific review to ensure that the appropriate validation steps have been followed and that the water continues to meet the Ph. Eur. specifications. Since, in the case of water, the validation will not be product specific, it is suggested that a company could request the supervisory authority to carry out a specific site inspection. The performance of such an inspection would be at the discretion of the supervisory authority and could involve a pharmaceutical assessor where necessary.
Since it is expected that the water will continue to meet Ph. Eur. specifications, if tested, no change to dossier requirements* (variations) would be involved and therefore no regulatory impact on individual products would normally be anticipated.
*This will depend on the level of detail in the original dossiers concerned.
- 2. Is sterility testing considered essential at the end of shelf life to confirm parenterals to be sterile? H+V May 2009
Sterility is part of the shelf-life specification.
Sterility testing should be performed at least at the end of shelf life but it can be replaced by testing of the container closure integrity. Depending on the nature of the container, intermittent integrity testing might be envisaged, independent of whether the sterility testing is replaced or not.


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Good morning, folks. We had our first sorta-monsoon storm here last night. I qualified it with a "sorta" because we got lots of wind, glorious Arizona lightning, thunder, but no rain. That's the desert for ya'. I loved it anyway.
On the agenda for today is a trip to IKEA in the afternoon and then over to my sister's house to watch Jurassic Park on their brand new HD big-screen TV. They wanted to do their part to stimulate the economy, I guess. We may also see fireworks in the evening if the boys are up for it.
TOTD: Last night, I watched a movie called Untraceable. Overall, the movie was good except I feel robbed of a decent ending.
Anyway, it's about an FBI agent who monitors and stops "cybercrimes." To track down a psycho killer who is streaming his grisly crimes live on the internet, they poured through thousands of message board posts, chat rooms, you name it, for clues.
Suppose an FBI agent is pouring through this particular board right now. Which poster would he suspect is really a psychotic killer and why?
My guess would be gator. He owns lots of guns, can be very irrational in his thinking, and he lives in Florida. Three strikes against you, darling. :p


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Comment: Scott Aaronson's take (Score 3, Funny) 199
Comment: Submarines? (Score 4, Insightful) 150
Comment: Re:Hmmmm ... (Score 1) 75
Comment: The primary point not in abstratct but not summary (Score 5, Informative) 17
Comment: The key here is "Conference Proceedings" (Score 4, Informative) 62
Labbé emphasizes that the nonsense computer science papers all appeared in subscription offerings. In his view, there is little evidence that open-access publishers — which charge fees to publish manuscripts — necessarily have less stringent peer review than subscription publishers.
Considering how many complaints there are about low-quality open-access journals, this suggests that that isn't nearly as much of an issue as some people are claiming.
Comment: Re:Gravity wells and other distance issues (Score 1) 330
Comment: Re:Gravity wells and other distance issues (Score 2) 330
Comment: Gravity wells and other distance issues (Score 5, Informative) 330
A major issue is that the moon is fairly far up Earth's gravity well. It is easy to get things to low-Earth orbit and already tough to get things to even geo-stationary. The main saving of putting anything on the moon will come if you can do a large part of your construction on-site since otherwise moving that much material up is going to be tough. If you are doing automated construction on site you also are going to need to be able to make mainly a lot of solar cells. Solar cells are primarily silicon and there's already been prior research on refining the moon's regolith for silicon to manufacture electronic components and that looks possibly doable but one does need to get over some technical chemistry issues. See e.g. http://www.asi.org/adb/02/13/02/silicon-production.html.
The other issue is distance for power transmission: most designs for microwave power involve power transmission from at most a little over geo-stat at about 35,000 km. The distance to the moon is about 10 times that, so if you don't have a really tight beam, there are going to be issues. Also, since the moon change's position you are going to need a large number of sites on Earth that can receive the beam, and if you can't switch off smoothly between them always (which would itself require massive planet-wide infrastructure), you would still need power sources on Earth (possibly just massive storage facilities?) to deal with those times.
Overall, a really cool idea with a lot of technical hurdles. I hope they can make it work but I'm not optimistic.
Comment: Re:Roy Spencer has other motivation. (Score 1) 560
Nope, not really. The issue isn't his religion, it is that his religion by his own description motivates his conclusions and results. Not too long ago I was talking to an undergrad who said that he wanted to become a climate scientist because he wanted to get people to stop using fossil fuels. I told him that he should instead become an engineer.
The problem in a nutshell is that humans are deeply imperfect. So when we have external motivations, and those motivations are strong enough, they distort what we do. That can occur in a variety of ways such as the file drawer effect http://en.wikipedia.org/wiki/File_drawer_problem#File_drawer_effect but also more subtle issues. In this particular context, there are literally hundreds of predictions from the 1980s about what the climate would be like today. That means that there are very difficult decisions to make about which predictions one should compare to the current data, and how to measure how accurate they are. Spencer's own motivations make the decisions he makes there to be extremely problematic. And yes, science is universally reproducible, but we're not talking about whether to accept a specific paper in a journal (if we were climatologists who were doing so, I agree that Spencer's motivations should then not enter into that), we're talking about non-climatologists who have neither the full time nor full expertise to make a judgment about all the details of his claims. In that context, the fact that he has strong external motivation is highly relevant when scientists lacking that external bias by and large disagree with his conclusions.


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|News » Archives
Crusaders Open GVSU Big Meet Friday
Recap | Results
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Friday, February 10, 2012
Kevin Adamik (Elmhurst, Ill./York Community) and Nick Fagan (Sycamore, Ill./Sycamore) both moved up Valpo's all-time top-fives in their respective events, while Julian Smith (Chicago, Ill./Brother Rice) posted a pair of top-six finishes in invite-only events Friday evening as the Valparaiso men's track and field team opened competition at the GVSU Big Meet in Allendale, Mich.
Adamik registered a top-ten finish in the 600m dash on Friday evening, as the freshman crossed the line in 1:23.32, good for ninth place among the 33 competitors. His time was more than three seconds faster than his previous season best in the event and put him in third place all-time at Valpo in the 600m dash.
Fagan competed in a large field of 176 runners in the 5,000m run on Friday and acquitted himself well, placing 42nd with a time of 15:10.19. The senior's time was over 40 seconds faster than his season best in the 5K and vaults him into third place in Crusader history in the event with Valpo's fastest time in 12 years.
Smith earned spots in the invite-only sections of the 60m and 200m dashes Friday night and showed why he was chosen with stellar performances. The sophomore finished sixth in the 60m dash final with a time of 6.97 seconds, and then came up just one one-hundredth of a second shy of his own school record in the 200m dash, crossing the line in 21.71 seconds for a second-place finish.
Valparaiso concludes the GVSU Big Meet on Saturday with a long day of competition, slated for a 9 a.m. CST start.
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