Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
cGMP and Validation in Pharmaceutical Process Technology

cGMP and Validation in Pharmaceutical Process Technology

Chandra Sekhara Rao, Gonugunta

Paperback

Technology & Engineering

ISBN10: 6208445043
ISBN13: 9786208445041
Publisher: LAP Lambert Academic Publishing
Published: May 12 2025
Pages: 60
Weight: 0.21
Height: 0.14 Width: 6.00 Depth: 9.00
Language: English
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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