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Bioprocess Engineering 2nd Edition by Fikret Kargi,Michael Shuler
Edition 2ISBN: 9780130819086Bioprocess Engineering 2nd Edition by Fikret Kargi,Michael Shuler
Edition 2ISBN: 9780130819086 Exercise 1
What is GMP and how does it relate to the regulatory process for pharmaceuticals?
Explanation
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GMP stands for Good Manufacturing Practices. GMP certification is given to facilities in pharmaceuticals that produce drugs that are used in clinical trials or sold in the market. So, GMP regulates the authorization and licensing of the manufacture and sale of food and beverages, dietary supplements, and medical devices.
GMP involves the various aspects of pharmaceutical production like the design and layout of the manufacturing facility, the equipment's, procedures used, training of personnel involved in the production unit, and product handling.
During the production of the product, the plant layout and design must prevent contamination of the product. The flow of material, air, and personnel is also dictated by the plant layout and design. Thus, GMP relates to the regulation process for pharmaceuticals.
GMP involves the various aspects of pharmaceutical production like the design and layout of the manufacturing facility, the equipment's, procedures used, training of personnel involved in the production unit, and product handling.
During the production of the product, the plant layout and design must prevent contamination of the product. The flow of material, air, and personnel is also dictated by the plant layout and design. Thus, GMP relates to the regulation process for pharmaceuticals.
Bioprocess Engineering 2nd Edition by Fikret Kargi,Michael Shuler
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