Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

The title of this article is deliberatively provocative. 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, together with the associated general notices and general chapters, relates to their responsibilities under good manufacturing practices for ensuring data integrity. However, many pharmacopeial tests therein involve classical chemical analysis (e.g., color, appearance, titration) and rely on an analyst’s observation with little, if any, documented evidence for review. Hence, do pharmacopoeias inadvertently facilitate data integrity violations? 

In this article the authors look at the following topics:

• Purpose and role of the pharmacopeias
• 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 accurate (ALCOA) as well as complete, consistent, enduring, and available (ALCOA+) to pharmacopeial analysis to ensure data integrity.

Read this article in Pharmaceutical Technology's Regulatory Sourcebook October 2020 eBook.

Article Details

Pharmaceutical Technology
eBook: Regulatory Sourcebook, October 2020
October 2020
Pages: 30–40

Citation

When referring to this article, please cite it as C. Burgess and R.D. McDowall, “Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?" Pharmaceutical Technology Regulatory Sourcebook (October 2020).