Transcription of Guidance on Handling of Insoluble Matter ... - …
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Guidance on Handling of Insoluble Matter ... - …
_____ Page 1 of 19 ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE ( apic ) Guidance on Handling of Insoluble Matter and Foreign Particles in APIs Version 01 June 2015 apic Guidance on Insoluble Matter and Foreign Particles in APIs Page 2 of 19 Disclaimer This document represents voluntary Guidance for API manufacturers and their customers, and the contents should not be interpreted as regulatory requirements. Alternative approaches than those described here may also be used. Foreword The cefic * Sector Group apic (the Active Pharmaceutical Ingredients Committee) was founded in 1992 as a direct consequence of the rapidly increasing European regulatory requirements affecting the manufacture of Active Pharmaceutical Ingredients (APIs).
APIC Guidance on Insoluble Matter and Foreign Particles in APIs Page 4 of 19 1. Acknowledgements This document was drawn up by a group of experts within CEFIC / APIC.
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