Implementation of the standard is now expected to occur as the US FDA will be able to use NSF/IPEC 363 as either guidance or regulation for excipient GMP, according to a position paper from IPEC-Americas.
Maxine Frtiz, EVP of Pharma and Biotech at NSF Health Sciences, previously told us when the standard was first published that it could eventually reduce the number of pharma and biotech company audits on their supply chain partners.
Per ANSI requirements for the development of a consensus standard, representatives from several organizations including IPEC and FDA were members of the NSF 363 working group in developing the standard.
Despite the deadline for plans to implement the new standard, IPEC-Americas says that it recognizes that implementation may vary across the industry, and depend on the:
• State of conformance to the IPEC-PQG GMP Guide for Pharmaceutical Excipients;
• Complexity of the excipient produced;
• Number of excipients produced; and
• Resources available for upgrading a company’s quality management system.
Still, IPEC calls for the plans to implement the standard, as well as for companies to define their implementation timeframe for each manufacturing site.
Excipient manufacturers should perform gap assessments in quality management systems to identify where they’re not in conformance with the new standard, IPEC says. In addition, companies should compose teams from all affected areas by the new standard, such as in production, quality, maintenance, and others, to resolve any gaps.
IPEC also notes that in certain circumstances where the distributor provides excipients in unopened manufacturers’ packaging, “there will be fewer applicable requirements.” However, distributors that repackage excipients should consider some of the same issues that manufacturers will face.
The council also said it’s revising its excipient GMP audit guide to reflect the NSF/IPEC 363 Standard. The IPEC-PQG excipient GMP guide is being similarly revised as a “how to Guide” for implementing the NSF/IPEC 363 Standard and will clarify the requirements of the Standard with direction and examples.