cGMP are the Current Good Manufacturing Practices followed by the pharmaceutical and biotech firms to ensure that the products produced meet specific requirements for identity, strength, quality, efficacy and purity. FDA regulates these industries to ensure cGMPs are being followed by using the following tools:
- CGMP regulations: Laws which can incur criminal penalties when they are not followed; for example:
- 21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs; General Part
- 21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals
- 21 CFR Part 600 - Biological Products: General
- 21 CFR Part 11 - Electronic Records; Electronic Signatures
- FDA Guidance Documents (CDER and CBER): Formal documents representing the Agency's current thinking on a particular subject. Though guidelines are not legally binding, non-compliance may still lead to FDA actions. Alternate procedures and practices may also be acceptable but they must be carefully justified and adopting them presents a certain risk. These documents usually contain much more detail and "how to" information than FDA regulations. For example:
- GMPs for Bulk Drugs: Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
- Stability Testing: Q1A(R) Stability Testing of New Drug Substances and Products
- Validation of Analytical Procedures
- Bioanalytical Method Validation
- Analytical Procedures and Methods Validation
- Guideline on General Principles of Process Validation
- Guide To Inspections Validation Of Cleaning Processes
- Plus many, many more. Full listings: CDER and CBER.
Please visit our Document Library for a full list of helpful FDA documents as well as many others from other regulatory agencies and industry groups.
The GMP Institute, a division of ISPE, has published a a more detailed explanation about GMPs that is very helpful.