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Pharma IT Insights
CMC vs GMP
What's the Difference?
By Elizabeth Bao-My Nguyen
August 25, 2023
Pharma IT Insights
CMC VS GMP
By Elizabeth Bao-My Nguyen
August 25, 2023
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CMC vs GMP
Chemistry, Manufacturing, and Control (CMC) and Good Manufacturing Practices (GMP) are concepts used by the pharmaceutical and biotechnology industries to guarantee drug product quality, safety, and consistency. Although CMC and GMP practices share similarities, they are different. These differences and similarities are described in the Insight below.
What is CMC?
CMC covers all activities needed to produce the Active pharmaceutical ingredient and the clinical trial material. The activities can roughly be divided into development, production and batch release. Development covers both development of analytical methods, synthesis and formulation. During development several tools must be used including Quality Target Product Profile (QTPP) and Critical Production Parameters (CPP). All steps need to be validated. Production must be uniform and of consistent quality confirmed by analytical testing leading to batch release. Timely development and production including stability studies is a key element in the clinical development.
What is GMP?
The European Medicines Agency (EMA), have outlined a set of rules for Good Manufacturing Practice (GMP) in a number of directives. The rules cover all aspects of the production of medicine, personnel, premises, equipment, documentation, and production being key elements. Basic guidance can be found in EMA’s EudraLex vol. 4 and in-depth guidelines can be found in several guidelines published by EMA. These guidelines ensure the products are consistently manufactured, controlled, and distributed in accordance with the established quality standards.
The primary distinction between GMP and CMC is in their extent
CMC is the framework for producing clinical trial materials and the production must comply with GMP. So GMP is a prerequisite for performing high quality CMC tasks. By leveraging both CMC and GMP, pharmaceutical manufacturers can achieve regulatory compliance, maintain product integrity, and minimize drug production and distribution risks.
The above article was written from the perspective of manufacturers operating out of the European Union. For a review of this concept within the context of the US, check out our sister company DS Inpharmatics’ (DSI) blog post on the subject, here. Both Pharma IT and DSI are a part of the ProductLife Group.
If you need support with Chemistry, Manufacturing, and Control (CMC) or Good Manufacturing Practices (GMP) functions or strategy, our team can help. We also offer GMP Training. Reach out to Torben Elhauge today at toel@pharmait.dk or +45 20406689.
About the author
Elizabeth Bao-My Nguyen is a Junior Consultant specializing in marketing and communications projects. She is currently a second-year master’s student in Biotechnology at The University of Copenhagen.
