Pharmaceutical Technology - October 2020

PharmTech - Regulatory Sourcebook - October

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30 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m D ata integrity is one of the major problems facing the pharmaceutical industry, contract research organiza- tions (CROs), and contract manufacturing organiza- tions (CMOs) today. As a result of numerous non- compliances, poor data management practices, and falsification found in organizations, regulatory authorities and industry bodies have issued guidance documents to help companies comply with the good manufacturing practice (GMP) regulations and modern- ize their working practices (1–9). These are forcing companies to assess processes and systems for data vulnerabilities as well as ad- dress staff training in ethics and data integrity. However, one area that is not mentioned in any guidance document is the role of the pharmacopoeias and how they can inadvertently facilitate data in- tegrity violations in regulated laboratories. In this article the authors look at the following topics: • Purpose and role of the pharmacopoeias • Interaction of the monographs, general notices, and general chapters • Examination of a monograph and the interpretation into an analytical procedure to see how the testing structure in a pharmacopeia can inadvertently facilitate data integrity violations • Practical application of the requirements that data are attributable, legible, contemporaneous, original, and accu- rate (ALCOA), as well as complete, consistent, enduring, and available (ALCOA+) to pharmacopeial analysis to ensure data integrity. Data Integrity 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. LEOWOLFERT - STOCK.ADOBE.COM Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations? C. Burgess and R.D. McDowall Pharmacopoeias contain the legal standards for the quality of medicines with monographs for active ingredients, excipients, and finished products. Analysts should understand how a monograph and associated general notices and general chapters relate to good manufacturing practices for ensuring data integrity. However, many pharmacopeial tests therein involve classical chemical analysis and rely on an analyst's observation with little, if any, documented evidence for review. Hence, do pharmacopoeias inadvertently facilitate data integrity violations?

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