PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Part II), 1/17
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In January, 2017, this version of the PIC/S GMP (good manufacturing practices) Guide went into effect for use by pharmaceutical manufacturing sites.
Part II of the GMP Guide explains the principles and expectations for the manufacture of active substances (APIs) used as starting materials in medicinal products.
- See section 5.4 for recommendations regarding computerized systems
- Refer to section 6 for guidance on electronic documents and records
- Read section 12 for validation expectations
- See section 13 for change control requirements
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