- Internal cGMP Audits
- GLP Audits
- GCP Audits
- Contract Manufacturer Audits
- Quality Systems Evaluation
- Compliance Gap Assessments
- Mock FDA Audits
- Compounding Pharmacy Audits
- Pre Approval Inspection Support
- API ICH Q7A Audits
- Labeling/Packaging Audits
- Supplier Audits
- Surveillance Audits
- Validation Audits
- Design of Audit Programs
- Dietary Supplement Compliance Audits
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Contact GQA
- 1-303-459-2382
- 1-866-216-2815
- info@gqaconsulting.com
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Industry Definitions
21CFR 111
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements The Food and Drug Administration (FDA) has issued a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements being taken to promote and protect the public health. 21CFR 111 applies to both domestic and foreign companies that manufacture, test, package, label, hold, or distribute dietary supplements in the United States. Compliance enforcement to the regulation will be phased in, based on company size, over 3 years.
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