Glossary · USA: FDA device and drug rules
Drug cGMP (21 CFR Parts 210 and 211)
Also known as: Drug CGMP, 21 CFR 211, Current good manufacturing practice for finished pharmaceuticals, cGMP
Drug cGMP are the US FDA's current good manufacturing practice regulations for medicines, set out in 21 CFR Part 210 (general provisions) and Part 211 (finished pharmaceuticals). They set minimum requirements for the methods, facilities and controls used to manufacture, process, pack or hold a drug; a drug not made in conformity with cGMP is deemed adulterated under the FD&C Act.
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In one sentence
Drug cGMP (21 CFR Parts 210 and 211) are FDA's minimum requirements for making, packing and holding medicines; noncompliant drugs are deemed adulterated.
Example
During an FDA inspection of a tablet plant, the investigator finds that out-of-specification results were retested without investigation and cites the laboratory control and quality unit requirements of Part 211 on a Form FDA 483.
How it applies
- Content of Part 211: Organization and personnel (including the quality control unit), buildings and facilities, equipment, control of components and containers, production and process controls, packaging and labeling control, holding and distribution, laboratory controls, records and reports, and returned and salvaged drugs.
- Quality control unit: Has the responsibility and authority to approve or reject components, in-process materials, packaging, labeling and drug products, and to review production records.
- "Current": FDA expects manufacturers to use up-to-date technologies and systems; practices that were adequate decades ago may no longer be.
- Related rules and guidance: Biologics also fall under additional regulations; APIs are inspected against ICH Q7; FDA guidance such as process validation and data integrity Q&A explains current expectations.
- Technical documentation: Master production and control records, batch production records, laboratory records and complaint files are required records; FDA reviews them during inspections, and deficiencies are cited in Form FDA 483 observations and warning letters.
US drug cGMP vs. EU GMP
Both set comparable GMP expectations, and FDA and the EU have a mutual recognition agreement on GMP inspections. The US regulation is shorter and more general, and responsibility for release lies with the quality control unit. EU GMP (EudraLex Volume 4) is more detailed through its annexes, and each batch must be certified by a Qualified Person before release.