cGMP and Validation in Pharmaceutical Process Technology
| AUTHOR | Chandra Sekhara Rao, Gonugunta |
| PUBLISHER | LAP Lambert Academic Publishing (05/12/2025) |
| PRODUCT TYPE | Paperback (Paperback) |
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.
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Product Format
Product Details
ISBN-13:
9786208445041
ISBN-10:
6208445043
Binding:
Paperback or Softback (Trade Paperback (Us))
Content Language:
English
More Product Details
Page Count:
60
Carton Quantity:
118
Product Dimensions:
6.00 x 0.14 x 9.00 inches
Weight:
0.21 pound(s)
Country of Origin:
US
Subject Information
BISAC Categories
Technology & Engineering | Engineering (General)
Descriptions, Reviews, Etc.
publisher marketing
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.
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