PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Annexes), 1/17
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In January, 2017, a new version of the PIC/S GMP (good manufacturing practices) Guide went into effect for use by pharmaceutical manufacturing sites. The annexes to the GMP Guide provide additional information that is generally applicable for both finished medicinal products and active substances (APIs).
Annex 11 – Computerised Systems – aligns with Eudralex GMP Annex 11.
Other sections with information regarding computer systems include:
- Annex 3 – Manufacture of Radiopharmaceuticals
- Annex 17 – Parametric Release
- Annex 20 – Quality Risk Management
- Glossary
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