mind the PAT drive is to have a dynamic manufacturing process that compensates for variability both in raw materials & equipment to produce a consistent product. PAT implementation The challenge to date with PAT for pharmaceutical manufacturers is knowing how to start. A common problem is picking a complex process and getting mired in the challenge of collecting and analyzing the data. The following criteria serve as a basic framework for successful PAT roll-outs: (From A PAT Primer) Picking a simple process. (Think water for injection (WFI) or building monitoring system (BMS) All details and nuances are well understood and explained for that process. Determine what information is easily collected and accessible through current instrumentation. Understanding the appropriate intervals for collecting that data. Evaluating the tools available for reading and synchronizing the data. PAT tools In order to implement a successful PAT project, a combination of three main PAT tools is essential: Multivariate data acquisition and data analysis tools: usually advanced software packages which aid in design of experiments, collection of raw data and statistically analyzing this data in order to determine what parameters are CPP. Process analytical chemistry (PAC) tools: in-line and on-line analytical instruments used to measure those parameters that have been defined as CPP. These include mainly near infrared spectroscopy (NIRS); but also include biosensors, Raman spectroscopy, fiber optics and others. Continuous improvement and/or knowledge management tools: paper systems or software packages which accumulate Quality Control data acquired over time for specific processes with the aim of defining process weaknesses and implementing and monitoring process improvement initiatives. These products may be the same or separated from the statistical analysis tools above. Long-term goals The long-term goals of PAT are to: reduce production cycling time prevent rejection of batches enable real time release increase automation and control improve energy and material use facilitate continuous processing Currently NIR spectroscopy applications dominate the PAT projects. A possible next-generation solution is Energy Dispersive X-Ray Diffraction (EDXRD). For a detailed review of PAT tools see Scott, or Roggo. For an example of application see Gendre. Although the FDA's PAT initiative encourages process control based on the real-time acquired data, a small part of PAT applications goes beyond monitoring the processes and follows the PACT (‘Process Analytically Controlled Technology’) approach. MVA in PAT Fundamental to process analytical technology (PAT) initiatives are the basics of multivariate analysis (MVDA) and design of experiments (DoE). This