During 1995, speakers at different pharmaceutical industry meetings began to refer to a need for a separate GMP auditing program which focused on an excipient's manufacturing process.
Generally these references were used to point out differences in auditing a typical drug product manufacturing site, one which manufactured an API, and a third which produced an important excipient for pharmaceutical use. Auditing the last, however, frequently is radically different than the others because excipients often are being produced by chemical and food companies in multi-product facilities.
In addition, their scale of production is generally large and often comprises manufacture for multiple markets. Since many excipients perform different roles in drug formulations, frequently there are multiple excipient grades. It was also apparent from the meeting discussion that auditors from the pharmaceutical industry who had occasion to visit excipient manufacturers often did not have an in-depth understanding of excipient GMP requirements.
To address these issues, IPEA was founded in 2000 as an independent subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) to audit the facilities and systems used for the manufacture and distribution of pharmaceutical excipients.
IPEA provides independent third party audits of excipient manufacturers, following published USP and IPEC-PQG Excipient Good Manufacturing Practices guidance. Audits are performed using IPEA qualified auditors. The auditing service is available worldwide employing auditors residing in the geographic locales where the audits are performed.
IPEA GMP Certification Program Accredited by ANSI
IPEA has received accreditation of its excipient certification program from the American National Standards Institute (ANSI). Accreditation of the program, officially called the IPEA Excipient GMP Conformance Certification Program, by ANSI, signifies conformance to the International Organization for Standardization (ISO)/IEC Guide 65 on general requirements for companies and organizations operating product-certification systems.
IPEA's role is to provide assurance that audited excipients meet industry standards as defined by information chapter <1078> in the current USP, and the IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients.
To read more about the Certification Program, please click here.