current Good Manufacturing Practices cGMP versus GMP
Since the GMP’s are revised and updated annually in the United States, the most recent version is called the current Good Manufacturing Practices, (cGMP’s).
The “c” in GMP’s just means “current” revision. The regulations require that manufacturers follow the current Good Manufacturing Practices cGMP. The “current” in front of that just acknowledges that what is considered ‘actual, effective, improved’ over time. Typically, each year the FDA expects companies to continually improve and implement the most recent regulatory changes in their facilities bringing training to their employees annually in the updates procedures and standards.
Following these practices ensures that the end product is completely safe for human use and consumption. It also means that the products are efficacious and pure, without any errors or contaminations.
For the medical devices industry, the current good manufacturing practices cGMP’s requirements are described in Volume 21 of the Code of Federal Regulations Part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act). Refer to https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
For the Pharmaceutical industry, the cGMP requirements are described in Volume 21 of the Code of Federal Regulations Part 210 and 211 (21 CFR part 210 and 211).
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Three (3) Options to Create Quality Management Procedures:
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Food and Drug Administration References
Industry References: current Good Manufacturing Practices cGMP