BioPharm International - March2020

BioPharm International - Regulatory

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12 BioPharm International eBook March 2020 Monograph Development: Why and When to Participate This article explores another proactive advocacy approach that a bio/pharmaceutical company may take through participation in the development of new and revised monographs in the various pharmacopoeias. T his article is a continuation of the series intended to provide a practical guide to phar- macopoeia compliance for the bio/pharma- ceutical industry. The first articles provided details on why pharmacopoeia compliance is necessary (1) and why compliance is difficult to achieve and maintain (2). Subsequent articles provided a his- torical and global perspective of the pharmacopoeias (3) and described the benefits of global pharmacopoeia standards (4) that may be achieved through ongoing harmonization efforts (5). The process used to revise the pharmacopoeias was described (6) as was the associ- ated surveillance process used by the industry to mon- itor these revisions (7) to facilitate ongoing compliance with current pharmacopoeia requirements. It was noted that monitoring only the official revisions published by the pharmacopoeias puts a company in a reactive posi- tion to achieve compliance with updated requirements. Working further upstream to include surveillance of proposed updates published by the pharmacopoeias provides an opportunity for companies to take a more proactive position by providing comments to poten- iQoncept - J. MARK WIGGINS is owner and compendial consultant with Global Pharmacopoeia Solutions LLC. JOSEPH A. ALBANESE is the director of Analytical Strategy and Compliance at Janssen Research and Development, LLC. J. MARK WIGGINS AND JOSEPH A. ALBANESE Regulatory Sourcebook Pharmacopoeia Compliance Series

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