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IEC QA Guide & Template Content, application and benefit for industry Dr. Johanna Gisele Evenki Industries AG Amsterdam, June 2014Agenda Why quality agreements? Regulatory requirements Objectives
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ipec qa guide amp stands for International Pharmaceutical Excipients Council quality assurance guide for active pharmaceutical ingredients.
Manufacturers and suppliers of active pharmaceutical ingredients are required to file ipec qa guide amp.
To fill out ipec qa guide amp, manufacturers and suppliers need to provide detailed information about the quality assurance measures in place for their active pharmaceutical ingredients.
The purpose of ipec qa guide amp is to ensure the quality and safety of active pharmaceutical ingredients used in the manufacturing of medicines.
Information such as quality control procedures, testing methods, specifications, and validation data must be reported on ipec qa guide amp.
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