Audit 17 - Auditing an Active API Manufacturer
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An active pharmaceutical ingredient or API is the therapeutic material found in a drug product. It can be derived from a chemical or biological sources. Along with excipients it is the starting or raw material for a drug product. It is also defined as a drug substance in the ICH Q7A guidance- Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. This GMP guide is a truly harmonized guide developed through the ICH process involving both industry and regulators across the world. The guide is implemented in most parts of the world.
APIs are produced by processes different from drug product processes. Some of these processes are chemical or enzymatic reactions, recombinant DNA technology, cell culture/fermentation, recovery from natural materials, or a combination of processes.
API processes are characterized by transforming the starting material and intermediates through a number (e.g. as few as 2-3 for simple chemical synthesis to 100’ of steps for peptides) of process stages before purification and isolation. The importance of the process step to the critical quality attributes of the API usually increases as one approaches the final API stages, although some earlier steps may be key to API quality.