The guide and templates were published last week as updates to 2009 IPEC documents highlighting concepts of what should be in Quality Agreements between excipient suppliers and pharmaceutical manufacturers.
“With new regulatory requirements a lot has changed,” an IPEC spokesperson told this publication. “The Guide was revised to better reflect these new expectations.”
For example, the excipient quality advocacy group said an increased focus on securing the quality of excipients and their supply is reflected in the new European Commission Guidelines 2015/C 95/02 on risk assessment for ascertaining the GMP for excipients, and the revised Eudralex Vol. 4, Guidelines for GMP for Medicinal Products for Human and Veterinary Use – Part 1; Chapter 5: Production Starting Materials.
Furthermore, the guide “aligns well with increasingly more global supply chains of excipients which may involve manufacturers and distributors in several locations, thus the guide has a global reach to excipient suppliers and users,” we were told.
“One of the biggest changes from a legislation perspective is the (EU) requirement for pharmaceutical manufacturers to ensure a given excipient was manufactured in accord with appropriate GMPs. In this revision of the IPEC Quality Agreement Guide, a new Manufacturer’s Quality Statement template is provided to address instances where the pharmaceutical company purchases excipients through a distributor.”
EXCiPACT and ANSI
The update also takes into consideration certification programmes for third-party auditor and excipient suppliers including ANSI and EXCiPACT, regulators have indicated can be used by pharmaceutical manufacturers to assist in risk assessment and developing supplier control strategies.
“For a certification scheme to meet these requirements, an assessment must be made to a suitable, recognised and published standard by an independent, credible organisation recognised internationally,” IPEC told us.
The spokesperson also told us such guidance and accreditation programmes are encouraging examples that regulators and industry are now recognising the issues surrounding pharmaceutical excipients.
“Excipients used in medicinal products are a diverse collection of materials sourced from many origins not exclusive to the pharmaceutical sector. Thus, excipients cannot be controlled by direct extrapolation of pharmaceutical legislation.
“It is encouraging that this is increasingly recognised and that risk assessment and voluntary guidance as made available by IPEC is helping to ensure the safe supply of high quality excipients.”
The updated guide and templates are available to download from IPEC’s website.