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Good Manufacturing Practice Requirements for Active Pharmaceutical Ingredients Used in Clinical Trials

Dr. Reiner Kirrstetter

Aventis Pharma AG, Global Quality Operations, Frankfurt/Main (Germany)

Dedicated to Dr. Manfred Worm on the occasion of his 60th birthday

Active Pharmaceutical Ingredients (APIs) used in clinical trials have to be manufactured under appropriate GMP conditions. Requirements for assuring GMP compliance during the development of API processes and the preparation of APIs for clinical use present a significant challenge to all development people, because development environments are characterized by frequent changes during the optimization activities and aggressive time lines as well. Until recently, no specific guidance was available for this area. But now, with the final version of the ICH Guideline Q7A, issued in November 2000, the GMP principles for APIs to be used in clinical trials are provided. These basic principles together with some industry perspectives on appropriate GMP controls are discussed. The fundamental goals of the quality management program are to ensure a appropriate level of control over production and testing of APIs, sufficient documentation of these operations, data integrity, and traceability of materials and documentation. In the end, process development has to deliver a validatable process for the API to guarantee a successful transfer to production, a successful process validation and a successful marketing authorization.