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Global Pharmacopoeia Solutions LLC
J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.
March 15, 2020
This series is intended to address the challenges for the industry to comply with pharmacopoeial requirements. This article returns to this important topic with a case study at the intersection of monograph development and compliance.
Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmacopoeia revision process.
This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.
This article returns to the topic of complying with pharmacopoeial requirements with a case study at the intersection of monograph development and compliance.
This case study is based on the experience of one of the authors but is applicable to all companies across the broader industry, illustrating the potentially surprising point that some compliance difficulties may be of the company’s own making.