BioPharm International - October 2020

BioPharm- October - Regulatory Sourcebook

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18 BioPharm International eBook October 2020 www.biopharminternational.com Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations? Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices. D ata integrity is one of the major prob- lems facing the pharmaceutical indus- t r y, cont rac t resea rc h orga n i z at ions (CROs), a nd cont rac t ma nu fac t u r ing organizations (CMOs) today. As a result of numerous non-compliances, poor data manage- ment practices, and falsification found in organi- zations, regulatory authorities and industry bodies have issued guidance documents to help companies comply with the good manufacturing practice (GMP) regulations and modernize their working practices (1–9). These are forcing companies to assess processes and systems for data vulnerabilities as well as address staff training in ethics and data integrity. However, one area that is not mentioned in any guidance doc- ument is the role of the pharmacopoeias and how they can inadvertently facilitate data integrity viola- tions in regulated laboratories. The title of this article is deliberatively provoc- ative. Pharmacopoeias contain the legal standards for the quality of medicines with monographs for active ingredients, excipients, and finished prod- ucts. Analysts should understand how a monograph, together with the associated general notices and gen- eral chapters, relates to their responsibilities under C. BURGESS is managing director of Burgess Analytical Consultancy Limited and is the writer of the Statistical Solutions column in Pharmaceutical Technology. R.D. MCDOWALL is director of R D McDowall Limited and is the author of Questions of Quality and Focus on Quality columns in LC-GC Europe and Spectroscopy, respectively. C. BURGESS AND R.D. MCDOWALL Regulatory Sourcebook Data Integrity leowolfert - Stock.adobe.com

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