NSF International has acquired the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC) as part of a way to ensure a more streamlined supplier qualification process.
NSF-IPEA is the only excipient GMP certification program accredited by the American National Standards Institute and offers third-party GMP audits based on Good Manufacturing Practices Guide for Pharmaceutical Excipients and excipient GMP certification.
“NSF certified excipient manufacturing facilities can provide their audit report to all of their pharmaceutical buyers as part of their supplier qualification process,” NSF Health Sciences Pharma Biotech VP Janeen Skutnik-Wilkinson, told us. “This essentially eliminates the need for duplicate audits from multiple buyers, saving excipient manufacturers time and cost associated with production disruptions from redundant audits.”
The IPEC-PQG excipient GMPs were used as the basis for developing the ANSI-NSF 363 Excipient GMP standard, which is in the final stages of development, Skutnik-Wilkinson said. “We expect ANSI-NSF 363 to be finalized in the first half of 2014.”
She also noted the importance of excipient GMPs, which she said are an integral part of US and EU regulations, and currently pending in Brazil and China.
“With the growing demand for credible, third-party excipient GMP auditing services and NSF International’s expertise in standards development and its global presence and auditor network, this acquisition was a natural next step for NSF.”
NSF also plans to add new auditors once the deal is complete.
“As part of the acquisition, NSF Health Sciences is in the process of on-boarding the existing IPEA auditors and will also be hiring additional auditors,” she added. “All Auditors must be suitably qualified with experience in pharmaceutical/excipient GMP auditing, and have participated in the excipient-specific GMP training which has been developed by IPEC.”
The IPEA program auditors will remain and additional auditors will be trained and certified by the International Register of Certificated Auditors (IRCA).
“Our goal was to provide a high quality and efficient auditing program for excipient manufacturers seeking to demonstrate their regulatory compliance as well as to provide excipient buyers with greater supply chain oversight,” Skutnik-Wilkinson said.