PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Introduction), 1/17
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In January, 2017, this new version of the PIC/S GMP (good manufacturing practices) Guide went into effect for use by pharmaceutical manufacturing sites.
This introductory document explains the organization of Parts I and II of the document, the Annexes, the history of PIC/S, and the document’s revision history.
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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 (Part I), 1/17
In January, 2017 this PIC/S GMP guide went into effect. It includes expectations for documentation and expectations for validation.
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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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