The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) was formed 30 years ago in response to the need for improved harmonization of standards for excipients.

The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) was formed 30 years ago in response to the need for improved harmonization of standards for excipients. Subsequent tragic incidents such as contaminated medicines, economically motivated adulteration, and diethylene glycol poisoning as well as a lack of excipient good manufacturing practices (GMPs), appropriate guidelines for excipient supplier audits, and an independent means to evaluate 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 product. Once thought of as “inactive” or “inert,” excipients are now recognized for their critical role in facilitating drug delivery. In the absence of regulatory guidance, IPEC-Americas has developed guides and other resources as well as education and training targeted for the pharmaceutical industry. 

IPEC-Americas is proud to represent excipient stakeholders, which make modern pharmaceuticals possible. IPEC-Americas’ mission is to advocate, educate, innovate, and develop best practices for excipients, with a focus on patient safety. The organization achieves this by contributing to the development of science-based policies by regulators, pharmacopoeias, and the pharmaceutical industry to support the safe and efficacious use of excipients 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 various trade associations in countries throughout the Americas including Brazil, Argentina, Mexico, and Canada. In addition, IPEC-Americas formed the IPEC Foundation to encourage excipient academic and industry research and recognize individuals who have contributed significantly to the field of excipients.

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

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 foundation for the NSF/IPEC/ANSI 363 Good Manufacturing Practices for Pharmaceutical Excipients standard. 
2. Supporting pharmacopeial harmonization of excipient monographs and general chapters. 
3. Collaborating with and providing 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 opportunities on excipient-related topics for excipient manufacturers and pharmaceutical companies through conferences, 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 partners, 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 eventually 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 addition to guides, 18 position papers have been published on topics such as risk assessment, data integrity, and atypical actives. IPEC-Americas has also published articles on a variety of hot topics, including qualification of excipient suppliers, elemental impurities, nitrosamines, and microplastics. 

Future 

What does the future hold for excipients? New and novel excipients are needed to support the development of modern drugs and drug delivery systems. Novel excipients will also be needed for advanced manufacturing processes such as 3D printing, continuous manufacturing, the manufacture of biologics and vaccines, and other emerging technologies. IPEC-Americas is well positioned to facilitate these new excipient applications through guides and provide expertise to ensure that these innovative technologies can become a reality. 

Going forward, IPEC-Americas will continue in its role as the “excipient experts.” The organization will work to expand excipient knowledge and relevance to ensure that the pharmaceutical industry has the excipients it needs to make the drug products of tomorrow. 

IPEC-Americas (571 814 3449, www. ipecamericas.org) is a US trade association whose members include excipient producers, distributors, and finished drug product manufacturers, as well as companies and individuals that supply other specialized services to industry segments. IPEC-Americas brings together these diverse stakeholders to achieve the common objective of safe and effective production and use of excipients.