Pharmaceutical Technology - September 2021


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Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 45 Package (EIP) Guide. The organization also worked with toxicologists around the world to update the soon to be published IPEC Safety Guide for Phar- maceutical Excipients. Pharmaceutical Technology asked Kim Beals, E xecut ive Di rec tor of IPEC-A mer icas, how COVID-19 impacted IPEC-Americas in 2021 and what the organization has planned for 2022. PharmTech: How has COVID-19 impacted IPEC training and workshops? How has the organization worked to resolve the impact? Beals (IPEC-Americas): Although the IPEC-Amer- icas Excipient Learning Lab has provided we- binars, workshops, and eLearning courses for several years, the number of webinars hosted by IPEC-Americas almost doubled, increasing from eight in 2019 to 17 each in 2020 and 2021. The biggest challenge was transitioning in-person workshops and brea k-out sessions to remote learning. However, with the available platforms (e.g., Zoom) and tools (ability to place attendees into separate rooms), we quickly transitioned and adapted, thus strengthening our ability to deliver more remote training. PharmTech: What initiatives are planned for 2022? Beals (IPEC-Americas): After celebrating our 30th anniversary this year of being the go-to organi- zation for excipients, IPEC-Americas plans to continue to develop and promote excipient best practices through webinars, trainings, and collab- orations with regulators and other organizations. In addition, IPEC has partnered with [the Prod- uct Quality Research Institute] PQRI to provide a continuous manufacturing workshop in Q2 2022 and is currently working with members of other regional IPECs to initiate a cross-functional/ cross-regional team to address emerging concerns for the use of nanomaterials. IPEC-Americas also has plans to further strengthen existing relation- ships with regulators and other pharmaceutical industry stakeholders in Latin America. PharmTech: What can you tell us about any new IPEC reports planned for 2022? Beals (IPEC-Americ as): Pla ns are under way to publish two revised guides (General Glossary of Terms and Acronyms and the Safety Guide for Pharmaceutical Excipients) and two new guides (How To GMP Guide and Validation Guide) this year and to finalize/publish five revised guides (CoA, Stability, Excipient Information Package [EIP], GDP and GMP Audit Guides) and and two new guides (EIP Sustainability and GDP How To Guide) in 2022. In addition, in 2021 IPEC- Americas members published seven articles in pharmaceutical trade journals (Pharmaceutical Technology ["Novel Excipients and Additives and Process Aids"], Tablets & Capsules ["IPEC- A mericas Celebrates 30 Yea rs"], Outsourced Pharma [three-part series on quality by design], and International Journal of Biological Macro- molecules [rebuttal to published article on car- boxymethyl cellulose]).PT "IPEC-Americas plans to continue to develop and promote excipient best practices through webinars, trainings, and collaborations with regulators and other organizations." —Kim Beals, IPEC-Americas

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