Implementing the ANSI NSF-IPEC 363 Standard on Excipient GMPs Will Help Ensure Compliance with FDASIA, FMD and EU’s New Excipient Risk Assessment Guideline

Implementation of the ANSI NSF-IPEC 363 standard on GMPs for excipients by pharma and excipient manufacturers will help ensure that they are compliant with the supply chain mandates of the FDA Safety and Innovation Act (FDASIA), the EU Falsified Medicines Directive (FMD), and the newly-completed EU excipient risk assessment guideline.

At the International Pharmaceutical Excipient Council (IPEC)/ExcipientFest conference in late April in San Juan, Puerto Rico, IPEC Federation President Janeen Skutnik-Wilkinson discussed the import of the new ANSI NSF-IPEC 363 standard and how its implementation will help prepare both pharma and excipient manufacturers for meeting the FDASIA, FMD, and EU guideline expectations.

Skutnik-Wilkinson was heavily involved in the development of the standard and the 2006 IPEC/Pharmaceutical Quality Group (PQG) GMP guide out of which the standard grew.  Currently a Compliance and Standards Staff Associate at Biogen in addition to being President of the IPEC Federation – which includes regional councils in the US, Europe, Japan, and China – she was previously NSF Health Sciences Pharma-Biotech VP, and is a past chair of IPEC-Americas.

The most salient change in the consensus standard from the IPEC/PQG guide was incorporation of a more clearly-delineated risk-based approach to assuring the needed quality of pharmaceutical excipients (IPQ August 20, 2013).  The standard, completed in late 2014, provides a stand-alone, quality system-based GMP standard that industry and regulatory agencies can use in evaluating, auditing, and certifying excipient manufacturing and quality.

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