Tablets Capsules

TC0721

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38 July/August 2021 Tablets & Capsules b a c k p a g e IPEC-Americas celebrates 30 years The International Pharmaceutical Excipients Council of the Ameri- cas (IPEC-Americas) was formed 30 years ago in response to the need for improved harmonization of standards for excipients. Subsequent tragic inci- dents such as contaminated medicines, economically motivated adulteration, and diethylene glycol poisoning as well as a lack of excipient good manufac- turing practices (GMPs), appropriate guidelines for excipient supplier audits, and an independent means to evalu- ate the safety of excipients for use in drug products, quickly showed why an organization like IPEC-Americas was needed. Excipients are the components in drug delivery systems other than the active pharmaceutical ingredients (APIs) and often make up more than 95 percent of a pharmaceutical drug prod- uct. Once thought of as "inactive" or "inert," excipients are now recognized for their critical role in facilitating drug delivery. In the absence of reg- ulatory guidance, IPEC-Americas has developed guides and other resources as well as education and training tar- geted for the pharmaceutical industry. IPEC-Americas is proud to represent excipient stakeholders, which make modern pharmaceuticals possible. IPEC-Americas' mission is to advo- cate, educate, innovate, and develop best practices for excipients, with a focus on patient safety. The organiza- tion achieves this by contributing to the development of science-based poli- cies by regulators, pharmacopoeias, and the pharmaceutical industry to support the safe and efficacious use of excip- ients in drug products. The group's success has been built on collaboration between excipient manufacturers, users, and regulators from around the world. Evolution In 2009, IPEC-Americas, along with IPEC-Europe and IPEC-Japan, formed the IPEC Federation, which now also includes IPEC China and IPEC India, giving the group a global presence. IPEC-Americas has also developed collaborative partnerships with var- ious trade associations in countries throughout the Americas including Brazil, Argentina, Mexico, and Canada. In addition, IPEC-Americas formed the IPEC Foundation to encourage excip- ient academic and industry research and recognize individuals who have contributed significantly to the field of excipients. Accomplishments The organization's noteworthy accomplishments include: 1. Publishing excipient guides and position papers such as the IPEC Safety Guide for Pharmaceutical Excipients and the IPEC Excipient GMP guide, which was published at the urging of the FDA and then used as the founda- tion for the NSF/IPEC/ANSI 363 Good Manufacturing Practices for Pharma- ceutical Excipients standard. 2. Supporting pharmacopeial har- monization of excipient monographs and general chapters. 3. Collaborating with and provid- ing educational training to regulatory agencies such as the FDA, Health Canada, and ANVISA on excipient topics, including: the usefulness and accuracy of the inactive ingredient database (IID), novel excipients, GMPs for atypical actives, and quality by design (QbD). 4. Providing educational opportu- nities on excipient-related topics for excipient manufacturers and pharma- ceutical companies through confer- ences, webinars, and training courses. 5. Establishing the first shared audit and ANSI-accredited excipient GMP certification programs. 6. Developing an independent safety evaluation process for new excipients. Publications Since 1995, when IPEC-Americas developed its first GMP Guide for Bulk Pharmaceutical Excipients, the organization has, individually and with its international IPEC Federation part- ners, published almost 30 guides on a range of topics, including excipient validation, QbD, and composition. One of the organization's proudest achievements was the evolution of the original GMP guide (1995) to the globally accepted IPEC/PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients that eventu- ally became the blueprint for the NSF/ IPEC/ANSI 363 Good Manufacturing Practices for Pharmaceutical Excipients standard and the EXCiPACT excipient GMP certification scheme. Five IPEC guides have been adopted by the US Pharmacopoeia (USP) and published as general chapters. In addi- tion to guides, 18 position papers have been published on topics such as risk assessment, data integrity, and atyp- ical actives. IPEC-Americas has also published articles on a variety of hot Highlights of IPEC-Americas guidance 1995 GMP guide for bulk pharmaceutical excipients 2005 Significant Change guide 2005 Excipient Information package 2006 Joint IPEC-PQG GMP guide 2008 Excipient Qualification guide 2012 EXCiPACT scheme 2014 NSF/IPEC/ANSI GMP standard 2017 Risk Assessment guide 2021 Validation guide

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