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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PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Annexes), 1/17
In January, 2017, this PIC/S GMP Guide went into effect. The annexes provide additional information applicable to both finished medicinal products and active substances (APIs).
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PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Introduction), 1/17
Introduction to the January, 2017 version of the PIC/S GMP (good manufacturing practices) Guide. Explains the organization of Parts I and II and the Annexes
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PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Part II), 1/17
This January, 2017 PIC/S GMP guide contains recommendations for computerized systems, electronic documents, validation, and change control.
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