What is gmp and sop?

Answer 1

GMP: Good Manufacturing Practices. A U. S. FDA term for a documented quality system similar to ISO 9001, for FDA-regulated industries. Medical device GMPs are defined in 21 CFR 820, pharmaceuticals are in 21 CFR 210, 211, and dietary supplements are under 21 CFR 111. Companies producing medical products for sale in the U.S. must comply with the appropriate regulation.

CGMP: Current GMP. The above GMPs are the minimum requirements. The FDA expects companies to continuously improve to best practices in their industry, which is represented by the "C".

The GMP family of acronyms is expanding: GXP is all inclusive; GCP: Good Clinical Practices; GLP: Good Lab Practices. (see also GxP and Best Practices).

SOP: Standard Operating Procedure. Written instructions as to how to perform or fulfill a specific requirement. Under ISO 9000 family of quality management systems, the SOPs generally fall between the top / high level Quality Manual, and the very detailed Work Instruction. Under a quality management system, all these documents are "controlled documents, meaning they must be formally approved, under a "change control" system, with only the current version used, and older originals archived, older copies (which were also controlled as to distribution) destroyed.