Member countries should: make provision for the maintenance of confidentiality, not only by Inspectors but also by any other persons who gain access to confidential information as a result of GLP compliance monitoring activities, ensure that unless all commercially sensitive and confidential information has been excised, reports of laboratory inspections and study audits are made available only to regulatory authorities and, where appropriate, to the laboratories inspected or concerned with study audits and/or to study sponsors.
- garantire che, fatto salvo il caso in cui siano state eliminate tutte le informazioni commercialmente importanti e riservate, i rapporti delle ispezioni di laboratorio e delle revisioni di studi siano messi a disposizione soltanto degli enti responsabili e, ove necessario, dei laboratori ispezionati o interessati alle revisioni e/o dei patrocinatori dello studio.