Quality control of excipients pdf

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These guidelines provide advice on the quality management system within which the analysis of active pharmaceutical ingredients (APIs), excipients.Good practices in production and quality control. 7.1 Change control and process form manufacturers may have a limited control over excipient quality. pharmaceutical user to define excipient quality requirements. i ICH Q9, Quality Risk Management, ich.org/LOB/media/MEDIA1957.pdf Testing active pharmaceutical ingredients and excipients is one of the main tasks of the quality control units in the pharmaceutical industry.