Overview
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Overview |
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Why do GMPs exist? |
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How were GMPs developed? |
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How GMPs change |
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How do GMPs of different countries compare? |
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Is there an effort to make one, "universal" set of GMPs? |
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Good Manufacturing Practices (GMPs) are regulations that describe the methods, equipment, facilities, and controls required for producing:
- Human pharmaceutical products and veterinary products (21 CFR 210-211)
- Biologically derived products (21 CFR 600 and 21 CFR 620)
- Medical devices (21 CFR 820)
- Processed food (21 CFR 100)
The U.S. pharmaceutical product regulations are called "current" Good Manufacturing regulations or "cGMPs", to emphasize that the expectations are dynamic.
