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Good Manufacturing practices


Good Manufacturing Practice (GMP) (or current Good Manufacturing Practice (cGMP)) refers to the manufacturing and quality control of food and pharmaceutical products. It follows a holistic approach to ensure that food and pharmaceutical products are suitable for consumption. Every aspect of processing is controlled and documented. All manufacturing and testing equipment must be approved for use, and all operational methodologies and procedures used in drug manufacturing must be validated. Through this quality approach to manufacturing, companies minimise or eliminate contamination, mixed-ups and errors.

Although manufacturers can decide individually how best to implement the necessary controls specific to their own products and operations, in theory, many legal authorities may hold that a product is adulterated alone because the process was not performed according to GMP standards.

For more information:

Good Manufacturing Practice (GMP) / Quality System Regulation  
http://www.fda.gov/MedicalDevices/default.htm
http://www.fda.gov/cdrh/fr1007ap.pdf
21 CFR 820 - Quality System
Comparison Chart: 1996 Quality System Reg vs. 1978 Good Manufacturing Practice
Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996
ISO 9001:2000 and FDA Quality System



 

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