IPEC e-newsletter - Excipients Insight April/May 2018 - 15-05-18


Inside this issue


How excipient certification can reduce audit burden – for suppliers and users

EXCiPACT senior advisor Tony Scott has authored an article in Industrial Pharmacy (April 2018 edition; issue 57) explaining how  the EXCiPACT certification scheme can reduce the “unsustainable” audit burden for both suppliers and users of pharmaceutical excipients.

Pharmaceutical manufacturers are legally required to assess the suitability of their excipient supplier’s GMP to satisfy the outcome of the formalised risk assessment. As supplier questionnaires do not usually provide evidence of GMP compliance, physical audits are the only answer – third-party auditing via “demonstrably credible” schemes such as EXCiPACT, has become acceptable to regulators as a means of alleviating the audit burden.

“By the end of 2017, an ever-growing global list of pharmaceutical excipient suppliers have been certified for GMP and/or GDP by EXCiPACT registered Certification Bodies and published on www.excipact.org,” writes Scott.

“This list is being regularly used by MAHs as a reliable source during their supplier qualification process as it offers direct access to audit reports and certificates and has taken the place of many individual audits.”




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