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www.biopharminternational.com October 2021 eBook BioPharm International 33 Regulatory Sourcebook Industry Perspectives • Fo r m a t i o n o f a 2 7- m e m b e r , inter nat iona l ly d iverse Remote A u d it s a n d I n s p e c t i o n s Ta s k Force that produced a workshop in April and published Points to C on side r in R emote and Hyb r id G M P /G DP In s p e c t i o n s , a n d i s c u r rent ly prepa r i ng to publ ish Points to Consider in Remote and Hybrid Audits. BioPharm: W hat initiatives are planned for 2022? J o h n s o n ( PDA ): P DA m e m- bers and the industr y at large can expect more of the same in 2022 as PDA continues to support its Vision and Mission, despite the challenges posed by the ongoing pandemic. BioPharm: How has COV ID-19 impacted PDA events? How has the organization worked to resolve the impact? Does PDA have plans for events in 2022? J o h n s o n ( P DA ) : J u s t a f e w weeks before the 2020 PDA Annual Meeting, PDA leadership made the historic decision to delay the confer- ence until July. More signif icantly, the conference was reschedu led as t h e f i r s t a l l-v i r t u a l P DA e v e nt . Since then, PDA has offered over 100 virtual conferences, workshops, training courses, and webinars. PDA's programming staff across our three regions worked diligently to improve the quality of the associ- ation's digital solutions in the second half of 2020, and PDA is proud to say its online events and training is of the highest quality among our peers. P D A d i d s c h e d u l e i t s f i r s t hybr id v ir t ua l /in-person event for October 2021, but due to the onset of t he COV I D-19 Delta va r ia nt 's t h i rd w ave of t he pa ndem ic , t hat event has been rescheduled as v ir- t ua l-on ly. PDA a nt ic ipates of fer- ing a mix of virtual-only events and hybrid events throughout 2022. PDA Education resumed in-per- son cou rses at t he PDA Tra in ing and Research Institute and on-site t r a i n i n g at compa ny lo c at ions i n January 2021. BioPharm: W hat can you tel l us about any new PDA repor ts or standards published in 2021? What does the organization have planned for 2022? Johnson (PDA): PDA has pro- duced a number of new reports and s t a n d a rd s i n 2 0 21. S om e of t h e highlights are … technical reports and points-to-consider documents on topic s suc h a s proce s s v a l id a- tion, enhanced test methods for vis- ible particle detection/enumeration, packaging integrit y, vial glass han- dling, and remote inspections. For t he rema i nder of 2 021 a nd look- ing ahead to 2022, we see techni- ca l publ icat ions on such topics as p o s t- ap prov a l c h a n g e s , c ont a m i- nation control strategies, microbial de v iat ions i nve st ig at ions , tec h n i- cal transfers, data integrit y, remote au d it s , l e s s on s l e a r ne d f rom t he pandemic, and more. We a lso see additional standards such as one on t he cr yopreser vat ion of cel ls used i n a d v a n c e d t h e r a p y m e d i c i n a l products (ATMP) and qualit y risk management of aseptic processes. It continues to be an exciting time for PDA and our members. BioPharm: What can you tell us about the qualit y-by-design (QbD) b o o k p u b l i s h e d i n 2 0 2 1? W h a t should manufacturers be aware of ? J o h n s o n ( P DA ) : Q u a l i t y b y Design: An Indispensable Approach to Accelerate Biopharmaceutical Product D e velo pme nt, ed ited by Cr ist ia na Campa, GSK, and M. Amin Khan, GreenLight Biosciences, Inc., fills in the gaps left by ICH [International Council for Harmonisation] Q8–11 for biopharmaceutica l manufact ur- ers. Based on the experience of lead- ing manufacturers and academia, it provides guidance on and practical examples of QbD principles related to product, process, and analytics. The book clarifies the importance of QbD as a key enabler of accelerated prod- uct development. Each of the book 's 21 chapters were written by different teams of exper t authors. They a re organized into seven sections that offer the latest systematic, risk-based approaches to product and process development in biopharmaceutics: • Critica l Qua lit y Attributes and Ranges • Formulation Development • Stability Modeling • Comparability • P r o c e s s U n d e r s t a n d i n g a n d Modeling • A n a l y t i c a l S t r a t e g y a n d Modeling • Platform Knowledge. BP Associates of Cape Cod ............................................................................................................................ 7 Entegris ...................................................................................................................................................... 11 Sartorius..................................................................................................................................................... 19 WuXi ............................................................................................................................................................. 3 Ad Index COMPANY PAGE