Good manufacturing practice

FDA document originally promulgated in 1974 but recodified several times with Sanitation as Part 110. Today, it is called Current Good Manufacturing Practices, meaning up-to-date GMP There are many ramifications dealing with GMP including: Part 7 – Recall Guide- lines, Part 108 – Emergency Permit Controls, Part 109 – Unavoidable Contaminants, Part 113 – Low-Acid Foods, Part 318 (9 CFR) – Meat Canning Regulations. Basically, the GMP defines standards for the operation and management of food factories, their environment, facilities, processes, plant, equipment and personnel in order to ensure the safe manufacture of food.


The set of general methodologies, practices, and procedures mandated by the Food and Drug Administration (FDA) which is to be followed in the testing and manufacture of pharmaceuticals. The purpose of GMPs is essentially to provide for record keeping and in a wider context to protect the public. GMP guidelines exist instead of specific regulations due to the newness of the technology, and may later be superceded (modified) due to further advances in technology and understanding.


A manufacturing system that complies with the highest standards of hygiene, safety and quality.


 


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