Effective immediately, the NSF International business unit formerly known as International Pharmaceutical Excipient Auditing, Inc. (IPEA) has been renamed NSF Excipient Certification Program (NSF-ECP).

NSF/IPEC/ANSI 363 Good Manufacturing Practice (GMP) for Pharmaceutical Excipients was released on December 11, 2014. The standard was developed as a consensus standard involving excipient manufacturers, excipient customers and the U.S. Food and Drug Administration.  

NSF-ECP expects that manufacturers will require a suitable transition period in order to fully meet the requirements of this new GMP standard, because of the complexities of the excipient manufacturing process, site operations, number of excipients produced and state of the company quality systems. This transition period should be factored into a company’s timeline. 

Beginning August 1, 2015, companies formerly certified against Pharmaceutical Quality Guide (PQG) for Good Manufacturing Practices for Pharmaceutical Excipients will be assessed against the new standard in the next surveillance or re-certification audit. Prior to August 1, 2015, the PQG will continue to be the audit reference unless a company elects to be audited against the NSF 363 Standard. Companies who are audited against NSF 363 and do not meet the standard requirements will be expected to have a plan in place with reasonable timelines to meet the requirements. Certification extensions of up to six months will be granted to previously certified companies electing to be audited against the NSF 363 standard. 

Questions regarding this approach can be directed to the NSF-ECP management. Please contact Austin Caudle at acaudle@nsf.org or Maxine Fritz at mfritz@nsf.org.