Inside IPEC: IPEC Tackles Monographs, Impurities, Particles, and More

As the excipient supply chain becomes more complex, industry must up the ante to comply with new standards and regulations.
Dec 02, 2011

A little over 18 months since it was established, the strategy and work programs of the International Pharmaceutical Excipients Council (IPEC) Federation have started to take shape. The federation's overall focus is to provide expertise on excipient regulatory and scientific issues, to assist in the harmonization of quality standards, and to promote global supply-chain security.

Originally formed with representatives from the four existing IPECs—IPEC-Americas, IPEC–Europe, IPEC–Japan (JPEC), and IPEC–China—the IPEC Federation is set to add IPEC-India to its membership. The federation also has formed partnerships in Latin America through trade associations in Brazil and Argentina and has a partnership with Mexico in the works. The following section summarizes recent progress made by the organization to date.

Monograph harmonization

One of the federation's priorities is the global harmonization of excipient monographs. The organization has been working in partnership with the Pharmacopoeial Discussion Group (PDG), which brings together experts from the US, European, and Japanese pharmacopeias. The two groups met in June 2011, and made progress on several fronts, including the inclusion of additives in pharmacopoeia monographs, where additives are typically present in commercially available materials, as well as standardization of methods for measuring viscosity of cellulosics. An IPEC working group will continue to consult within an industry coalition and plans to run a global workshop on viscosity of cellulosics to develop recommendations for discussion with PDG.

Recognizing that additives can be components in excipients is a major step-forward and work is ongoing to compile a comprehensive list of additives and processing aids that are typically used in the manufacture of excipients. The goal is to collaborate with regulatory authorities, including FDA, to find a way to "grandfather" the permitted inclusion of such components in specific excipients where their historical and safe use can be demonstrated and justified.

Third-party certification

One of the biggest projects undertaken since the formation of the IPEC Federation in 2010, is to support the third-party excipient-certification program known as EXCIPACT. The program is designed to complement other third-party schemes such as the ANSI-accredited International Pharmaceutical Excipient Auditing (IPEA) program set up by IPEC–Americas. The auditing program provides certification that an excipient manufacturer meets IPEC–Pharmaceutical Quality Group (PQG) Excipient GMPs. EXCIPACT will provide an equivalent certification for companies who already may be certified to ISO–9001, the international standard for quality-management systems, but that need their certification expanded to cover the additional requirements for excipient GMPs and good distribution practices (GDPs). The latter standards go beyond ISO–9001 to include requirement for contamination control, document traceability, cleaning, training, and so forth.

GMP and GDP legislation for excipients has been proposed in both Europe and the United States. As a result, excipient suppliers could be faced with an avalanche of quality audits and related requests to ensure customers and regulators that their facilities and products meet these new requirements. Excipient users will need to find a way to obtain physical audit information on every supplier they use and that cannot be done with available in-house audit resources.

Industry experts from the European Fine Chemicals Group (EFCG), IPEC–Europe, IPEC–Americas, PQG, and the European Association of Chemicals Distributors (FECC) developed the EXCIPACT certification scheme to provide industry with an alternative means to obtain independent assessment of manufacturers and suppliers of pharmaceutical excipients. Most suppliers are already ISO-certified, meaning that they meet a defined set of GMP and GDP standards. EXCIPACT and IPEA are two pathways that IPEC will be offering to achieve the same level of certification as ISO—one for companies that are already ISO-certified and one for companies that are not ISO-certified and want to go through a full certification to excipient GMPs.

IPEC–Japan recently established Self-imposed Standards for Manufacturing Control and Quality Control of Pharmaceutical Excipients and its Explanation. The English version of these standards will be published in 2011. IPEC–Japan also began a third-party certification system in 2005.

These programs demonstrate that excipient suppliers, distributors, and the pharmaceutical industry are fully committed to the use of high quality excipients and ensuring their integrity throughout the supply chain. The use of EXCIPACT and the IPEA certification schemes add a significant contribution to ensuring patient safety and supplier quality, while minimizing overall supply-chain costs.