Quality Rules in Active Pharmaceutical Ingredients Manufacture

Quality Rules in Active Pharmaceutical Ingredients Manufacture
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By:"John Sharp"
"Medical"
Published on 2002 by CRC Press

The fifth booklet in the best-selling Quality Rules series presents the basic concepts of quality and current Good Manufacturing Practice (cGMP) in a manner easily understood by operators involved in the manufacture and quality assurance of ...

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Provides an overview of current Good Manufacturing Practice and the manufacture of sterile products Describes the types and sources of contamination Addresses the control of contamination by cleaning and disinfection Discusses the various methods for sterilizing drug products The fifth booklet in the best-selling Quality Rules series presents the basic concepts of quality and current Good Manufacturing Practice (cGMP) in a manner easily understood by operators involved in the manufacture and quality assurance of active pharmaceutical ingredients (APIs). Drawing on the guidelines prepared under the ICH and made available by the US FDA, this booklet covers all the cGMP concepts required as training, retraining, and reinforcement resource for workers recently hired into the API manufacturing industry. In his familiar, no-nonsense style, the author explains the rationale of cGMP and the key role played by workers in the production and packaging of pure, safe, and quality APIs.

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