What Good Mfg Practice (GMP) requires
Good Manufacturing Practice (GMP) (21 CFR Parts 210 and 211) is the primary U.S. and global standard for ensuring that pharmaceutical and medical device products are consistently produced and controlled according to high-quality standards. it is designed to minimize the risks involved in production that cannot be eliminated through testing the final product.
Pillar: Medical & Healthcare · Authority: European Medicines Agency (EMA) · Version: 1.1.0 · Last updated:
Primary source: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice
SHA-256 integrity: a938115e084a26b1f50d169951131d8b635611a1df9d29a3efd3fb75cb52797a
Primary Citations — 6 traced to source
- 21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
- 21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals
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