The pandemic experience and the increasing expectations of regulators regarding supply chain visibility and risk-management are driving forces for incorporating more third-party auditing of excipient suppliers into user quality management systems.
The need to increase oversight of the excipient supply chain while at the same time reducing the commensurate workload is being addressed through these third-party auditing programs. The auditors involved are qualified under a certification scheme, which assures the audits meet the needs of excipient suppliers and pharma users.
Regulators for some time have viewed third-party auditors certified against recognized standards as qualified to perform the excipient audits, provided that the certifying scheme was credible. The International Pharmaceutical Excipients Council (IPEC) Federation and its various regional members have been active in setting standards as well as establishing an excipient GMP certification process.
EXCiPACT was established in 2012 as a non-profit excipient GMP certification scheme owner by six globally dispersed excipient trade associations, including the IPECs. It was originally qualified against International Organization for Standardization (ISO) standards, reflecting its global operations.
[See IPQ August 20, 2013 and May 5, 2015 for more background on IPEC’s role in establishing standards for excipients and on the development of EXCiPACT and other third-party auditing programs.]
In the ten years since EXCiPACT was launched, it has certified seven auditing bodies. These bodies, in turn, have certified approximately 150 supplier sites around the world, including large-scale operations for companies such as Ashland, BASF, and Colorcon.
In November 2021, IPEC-Americas hosted a webinar on the developments in third-party excipient auditing, with insights on how IPEC’s guidance efforts have helped support the EXCiPACT program. More recently, these efforts have included IPEC’s “GMP Certification Scheme and Certification Body Qualification Guide,” published in 2020, and an audit guide on excipient good distribution practices (GDP), released in 2021.
The webinar panel covered the full spectrum of the third-party auditing process – with perspectives, experience, and learnings from scheme owner EXCiPACT, the certified body SGS, excipient maker Dow, and excipient user Novartis. [The panel discussion is appended in full below.]
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