Supplier quality management: Monitoring the quality and compliance of API suppliers, defining Generic Pharma as the customer.

摘要

This thesis presents the theory of applying a detailed internal company system, Supplier Quality Management (SQM), which not only establishes, but monitors the quality and compliance of Active Pharmaceutical Ingredient (API) suppliers under the appropriate regulations and guidances. The Generic Pharmaceutical Industry is defined as the customer. The product is defined as the finished pharmaceutical drug product for use by the consumer.;There are no real strict regulations, or guidances, from the FDA, whereby 21CFR Parts 210 and 211 are loosely applied, unless the API manufacturer states they comply with these regulations, on this subject. Rather FDA and Generic Pharma utilize ICH Q7: cGMPs for API Manufacturing, among other pertinent ICH guidances.;The evolution of the concept of establishing supplier quality, especially a Supplier Quality Management (SQM) system, is examined to understand its intent in drug product formulation, protecting the drug consumer, the current expectations of pharmaceutical manufacturers, and the cost of non-compliance.