PIC/S

PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Part I), 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 I of the GMP Guide explains the general principles and expectations for the manufacture of medicinal products.

  • Chapter 4 contains expectations for documentation – including documentation in electronic format
  • Section 21-24 of Chapter 5 outline expectations for validation
  • There are notes throughout the Guide regarding the use of validated systems
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