cGMP and Validation in Pharmaceutical Process Technology

Language: English

Published by LAP LAMBERT Academic Publishing, 2025

6208445043 / 9786208445041

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Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH

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nach der Bestellung gedruckt Neuware - Printed after ordering - GMP is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standard appropriate to their intended use and as required by the marketing authorization. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take protective steps to ensure that their products are safe, pure, and effective. Require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. Protects the consumer from purchasing a product, which is not effective or even dangerous. GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Validation is an essential part of good manufacturing practices (GMP). It is therefore an element of the pharmaceutical quality system. Validation as a concept, incorporates qualification and should be applied over the life cycle. The execution of validation should be in compliance with regulatory requirements.

Seller Inventory # 9786208445041

Title
cGMP and Validation in Pharmaceutical Process Technology
Author
Gonugunta Chandra Sekhara Rao
Publisher
LAP LAMBERT Academic Publishing
Publication year
2025
Condition
Neu
Binding
Taschenbuch
Language
English
ISBN 10
6208445043
ISBN 13
9786208445041
Item weight
107 grams
Dimensions
220x150x5 mm

AHA-BUCH GmbH

Einbeck, Germany

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