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Quality Rules in Active Pharmaceutical Ingredients Manufacture: American Edition (5-Pack)

Autor Santoro, Robin Goldstein, John Sharp
en Limba Engleză Paperback – 31 mai 2002
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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Specificații

ISBN-13: 9781574911398
ISBN-10: 1574911392
Pagini: 41
Dimensiuni: 159 x 202 x 34 mm
Greutate: 0.41 kg
Ediția:American
Editura: Informa Medical

Textul de pe ultima copertă

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.

Descriere

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 in a training, retraining, and reinforcement resource for workers recently hired into the API manufacturing industry. Using his trademark 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.