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cGMP and Validation in Pharmaceutical Process Technology

By Gonugunta Chandra Sekhara Rao

Product Image: cGMP and Validation in Pharmaceutical Process Technology

cGMP and Validation in Pharmaceutical Process Technology

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Description
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.
Product details
Binding:
Paperback
Number of Pages:
60
Release Date:
2025-05-12
Publication Date:
2025-05-12
Publisher:
LAP LAMBERT Academic Publishing
Languages:
Original: English
ISBN10:
6208445043
ISBN13:
9786208445041
GPSR Manufacturer Reference:
[email protected]
Weight:
107 g
Height:
150 cm
Width:
220 cm
Thickness:
4 cm
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