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21 aprile 2016

FDA: Draft Guideline on Data Integrity

FDA: Draft Guideline on Data Integrity

 

Data manipulation and data integrity issues are topics that constantly appear in the press. In recent years, cGMP violations involving data integrity have been increasingly observed, especially in China and India. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy and quality of drugs. Following the MHRA and the WHO, that have both released draft documents on this subject in 2015, the US Food and Drug Administration (FDA) has now published a Draft Guidance on Data Integrity and Compliance with cGMP, as well.    The purpose of the guidance is to clarify the role of data integrity in cGMP for drugs, as required in 21 CFR 210, 211, 212 and Part 11.   “FDA expects that data be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and business models.” The 13-page document is structured in 18 questions with corresponding answers and defines the creation and handling of data in accordance with cGMP requirements. From the definition of data integrity to recommendations on when a computer system has to be validated up to the monitoring of electronic master production and control records – a wide range is tackled. Regarding the exclusion of cGMP data from the release criteria decision-making process (Question 2) FDA makes it very clear that there must be a valid, documented scientific justification. This hold true for any kind of records whether they are paper-based or electronic data record-keeping. Furthermore it has to be ensured that appropriate controls are given to assure that changes to computerized electronic master production and control records (MPCRs) can be made only by authorized personnel (Part 211.68 (b)). If you are interested in more details on this topic, please find the original document here. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance to http://www.regulations.gov.
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