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“How to do” Document

Cefic/APIC "How to do"- Document Page 1 of 39 GDP How to Do doc_finalMar 2019- TB proof read-English check Version 2 ACTIVE pharmaceutical INGREDIENTS COMMITTEE GDP for APIs: How to do Document Interpretation of the WHO Guideline GOOD TRADE AND DISTRIBUTION PRACTICES FOR pharmaceutical STARTING MATERIALS and the EU GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE Version 2 March 2019 Cefic/APIC "How to do"- Document Page 2 of 39 - GDP How to Do doc_finalMar 2019- TB proof read-English check Version 2 For Internal Use Only Preamble The original version of this guidance Document has been compiled by a subdivision of the APIC Good Distribution Practice Task Force on behalf of the Active pharmaceutical Ingredient Com-mittee (APIC) of CEFIC.

The explanatory notes in this guide are the views of The Active Pharmaceutical Ingredients Commit- tee (APIC) and not necessarily those of the European Commission or WHO. This document does not intend to provide an exhaustive list of how to comply with the require-

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