Issue link: https://www.e-digitaleditions.com/i/541292
IPEC-Americas and its role in excipient regulation The International Pharmaceutical Excipient Council of the Americas (IPEC-Americas) is a nonprofit trade associa- tion organized in 1991 with the goal of providing tools and other resources to help ensure that excipients are man- ufactured and distributed in a way that produces safe and effective drug products. These tools and resources address common excipient industry issues and include guides (e.g., Technically Unavoidable Particles Profile Guide), white papers, position papers, and training courses. Today, IPEC- Americas has 66 members who are excipient manufactur- ers, users, or distributors. [Editor's note: Tablets & Capsules is an associate member of IPEC-Americas.] The group has a good working relationship with the FDA and is recognized as an important source of science-based facts that support the safe manufacture, distribution, and use of excipients. IPEC-Americas provides collaborative solutions for excipient-industry stakeholders. It is also a reliable source of regulatory information and offers opportunities for members to discuss issues that affect makers, users, and distributors. Members can also discuss with regulators the implications and implementation of in-place and proposed regulations. This year, IPEC-Americas is developing a campaign to fos- ter cooperation and keep members and other excipient stakeholders up to date about industry developments. IPEC-Americas has seven committees of volunteers that meet quarterly to further its goals. To date, members have helped develop and issue 11 guides that support the association's goals. Four of them have been adopted as USP General Chapters. Figure 1 provides a timeline of how these guides and USP General Chapters were issued and revised. Representatives from IPEC-Americas' mem- ber companies frequently give presentations at trade meetings and lead workshops and webinars to educate the pharmaceutical industry about using the group's guides. Stakeholder participation is a hallmark of IPEC- Americas' process for writing its guides, which offer both prescriptive and practical information to excipient makers, distributors, and users. The guides' overriding objective, however, is to ensure the quality of excipients used in drug products. It is therefore paramount that each guide incor- porate perspectives from all stakeholders, including, when applicable, regulatory authorities. Two recent guides that included review and comment by the FDA were IPEC's Certificate of Analysis Guide for Pharmaceutical Excipients (2013) and its Significant Change Guide for Pharmaceutical Excipients (third revision, 2014). More such documents, including QbD Sampling Guide and Continuous Verification of Pharmaceutical Excipients, are expected to be issued later this year. From 2002 through 2013, a subsidiary of IPEC- Americas, International Pharmaceutical Excipients Audi - ting (IPEA), provided workshops focused on the require- ments of excipient GMPs as originally established in the 1995 IPEC-Americas guide Good Manufacturing Practices for Bulk Pharmaceutical Excipients. In January 2014, IPEC- Americas sold IPEA to NSF International. While the sale transferred ownership of the excipient GMP certification program and the excipient auditing program to NSF, it did not include the IPEA training program. Retention of that program demonstrates the commitment of IPEC- Americas members to continuing education and training, not only in the use of the IPEC guides and the NSF/IPEC/ANSI 363 standard, but in a variety of topics important to excipient makers, users, and distributors. In fact, IPEC-Americas plans to expand its training program. 16 July 2015 Tablets & Capsules Figure 1 Timeline of IPEC-Americas' guidelines Safety evaluation of new excipients USP <1074> Excipient GMP distributor audit Excipient GMP USP <1078> Excipient COA USP <1080> Excipient GMP Rev 1 Excipient GMP Rev 2 Significant change USP <1095> Significant change Rev 1 Quality agreement Excipient composition Excipient GMP Audit Rev 1 Excipient GMP Audit IPEC-Americas Incorporated Good distribution practice Excipient distributor audit Excipient information package Excipient master file Excipient qualification Excipient GMP Audit Rev 2 Excipient information package Rev 1 Excipient COA Rev 1 Significant change Rev 2 Stability program 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11 12 13 14