Keeping up to Date with Excipients

 Keeping up to Date with Excipients

In a constantly changing industry, education is essential. Fortunately, communication technology has evolved along with drug development and manufacturing practices. IPEC-Americas offers educational opportunities in regulatory requirements, good manufacturing practices (GMP), and excipient science for excipient makers and users. It delivers its content in multiple modalities: webinars (live and recorded), workshops (in-person, remote, and on-site); guides and position papers; infographics; and Excipient World Conference and workshops. Here are more details about IPEC-Americas’ educational offerings: 

Webinars 

IPEC-Americas presents monthly webinars under two distinct brands (see Table 1). 

Table 1: Education


The webinars—presented by subject matter experts (SMEs)— include a presentation, followed by time for questions. Topics include regulatory requirements in major world markets, issues that affect excipient use such as the proposed restriction on the use of Titanium Dioxide, and proposed regulations to treat certain excipients as microplastics. Webinars are also offered whenever an IPEC guide is introduced or updated. For those unable to attend, IPEC-Americas offers recordings/copies of the presentation and Q&A. 

Workshops 

IPEC-Americas has offered public workshops since 2003. The IPEC Excipient GMP Compliance Workshop has evolved to the current virtual and in-person formats, which align with the NSF/IPEC/ANSI 363 Excipient GMP standard. The workshop has also been sponsored by both makers and users, tailored to meet their needs and delivered by IPEC-Americas SMEs at their sites. IPEC-Americas has hosted FDA personnel at several workshops so that regulators can obtain an industry perspective related to excipient GMP compliance and Quality By Design (QbD) expectations. 

Self-Paced Training 

Compliance to excipient GMPs requires employee training. IPEC-Americas developed online, self-paced presentations directed to front-line employees in production, laboratory, warehouse, and maintenance. Courses for leaders address the same topics—but emphasize management’s role. During each course, attendees complete an assessment before moving to the next module. Upon completion, attendees can print a certificate of attendance. 

Guides and Position Papers Since 1995, IPEC-Americas has issued guidelines applicable to excipients, beginning with the excipient GMP guide. Since then, IPEC-Americas and/or the IPEC Federation1 have developed various guides pertaining to regulatory, GMP, safety, and related topics. Guides are developed by SMEs representing excipient makers and users and are often supported with input from regulatory authorities. IPEC has also developed position papers on emerging topics such as qualification of suppliers, application of data integrity to excipient manufacture, and assessing the potential for nitrosamines in excipients. Guides and position papers are available on the IPEC-Americas website and are free to download. 

Infographics

In 2021, IPEC-Americas began developing infographics to present information in a concise and clear format. Various infographics have already been created, including Top Management Roles and Responsibilities, soon to be followed by Drug Master Files and Defining Excipient Composition. 

Excipient World

Finally, IPEC-Americas offers Excipient World Conference & Expo as an annual educational and networking meeting for excipient makers, distributors, users, and the public sector such as FDA and USP. Resources Links to register for education and training opportunities can be found on the IPEC-Americas website, ipecamericas.org. Guides, position papers, and infographics are also available on the IPECAmericas website and are free to download. More information about Excipient World can be found at Excipient World.org. 


References 

1. IPEC Federation - a global organization consisting of the existing regional IPECs: IPEC-Americas, IPEC Europe, IPEC Japan, IPEC China and IPEC India. 


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