BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

Issue link:

Contents of this Issue


Page 25 of 44

26 BioPharm International eBook September 2019 Regulatory Sourcebook Pharmacopoeia Compliance Series F or the bio/pharmaceutical industry, compliance with requirements published by pharmacopoeias around the world is a legal and regulatory require- ment in those countries and regions in which the pharmacopoeia is applicable. This article pro- vides a comprehensive, end-to-end framework to help companies who discover, develop, manufacture, and/or distribute small-molecule drug products, biotherapeutic products, and vaccines, as well as the drug substances and excipients used in these products, to better under- stand the external and internal challenges that make pharmacopoeia compliance difficult. Understanding the challenges enables an exploration of the approaches that may be taken to help ensure ongoing compliance with pharmacopoeia requirements. AN END-TO-END FRAMEWORK FOR PHARMACOPOEIA COMPLIANCE The critical question that must be asked is: what is necessary for compendial compliance? The answer is provided in an article describing the bio/pharmaceu- tical industry's pharmacopoeial surveillance process (1): a company must comply with current pharma- copoeia requirements. This was true when the arti- cle was written 15 years ago and is still true today. Ongoing compliance requires timely and effective J. MARK WIGGINS AND JOSEPH A. ALBANESE This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging. Why Pharmacopoeia Compliance Is Difficult iQoncept- J. MARK WIGGINS is owner and compendial consultant with Global Pharmacopoeia Solutions LLC. JOSEPH A. ALBANESE is the director o f A n al y tical St rat e g y an d Co mp lian ce at J ans s en Re s e arch an d Development, LLC.

Articles in this issue

Links on this page

Archives of this issue

view archives of BioPharm International - September 2019 - BioPharm - Regulatory Sourcebook