Eudralex V4 Annex 18: GMP Guidelines for Active Pharmaceutical Ingredients, 7/01

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Annex 18 provides the EU GMP requirements for API (active pharmaceutical ingredient) manufacturers.

See sections 2.22.9, 2.23.8, 5.4, 6.12, 12.1, 12.2, 12.3, 12.6, 13.11, and 13.13 for specific computer and validation requirements.