Pharmaceutical Technology - March 2020

Pharmaceutical Technology - Regulatory Sourcebook

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24 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 P h a r mTe c h . c o m Pharmacopoeia Compliance Series P revious articles in this series detailed the mono- graph development process, which is accomplished through partnership between the bio/pharmaceu- tical industry and the pharmacopoeias (1,2). Ratio- nale was provided to help companies decide whether they will participate in the process as a potential advocacy oppor- tunity for the company through monograph development for their drug substances and products. In a broader context, however, the overall series of articles is intended to address the challenges for the industry to comply with pharmaco- poeial requirements. This article returns to this important topic with a case study at the intersection of monograph development and compliance. The challenge of compliance The drug product lifecycle described in the first article of this series (3) provides context that is helpful for con- sidering compliance challenges. A company initially dis- covers a new drug substance and develops it into a drug product, performing clinical studies to ensure it is safe and effective. During development, the company establishes standards of quality that are considered appropriate for the drug substance and product. When all the necessary drug development information is available, it is submitted to regulatory agencies to gain marketing approval for the product in countries around the world. During the regula- tory review process, differences can emerge in the quality requirements that are approved for the product, based on determinations made by the health authorities in individual countries. These differences are often minor, but may also be quite significant, creating challenges for compliance in all countries where the product is approved. An extreme, but not uncommon, example can be imag- ined for a drug product that contains a genotoxic impurity. Differing views by different regulators as to the appropriate control for this impurity can lead to more than 20 differ- ent country-specific limits for the impurity. The company can then test and release the drug product to the individual limits that are approved in each country. A more common approach, however, is to apply the tightest approved limit to enable worldwide release of the product. Even with this global approach, individual certificates of analysis are re- quired to ref lect the approved limits in individual countries. 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. iQoncept - Stock.adobe.com A Practical Approach to Pharmacopoeia Compliance J. Mark Wiggins and Joseph A. Albanese In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work. Published articles in this series are available online at www.PharmTech.com/compendia: • Why Pharmacopoeia Compliance Is Necessary • Why Pharmacopoeia Compliance Is Difficult • A Brief History of Pharmacopoeias: A Global Perspective • Global Pharmacopoeia Standards: Why Harmonization is Needed • Harmonization Efforts by Pharmacopoeias and Regulatory Agencies • Revision Process for Global/National Pharmacopoeias • Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions • Monograph Development: Why and When to Participate • Monograph Development: How to Participate; How to Harmonize • A Practical Approach to Pharmacopoeia Compliance • A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials • Pharmacopoeia Compliance: Putting it All Together; What is on the Horizon

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