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32 BioPharm International eBook October 2021 www.biopharminternational.com Ac ronyms a nd t he Safet y Guide for Pharmaceutical Excipients) and t wo ne w g u ide s (Ho w To G M P G u i d e and Validation Guide) this year and t o f i n a l i z e /p u b l i s h f i v e r e v i s e d g u ides (CoA , Stabi l it y, E xc ipient Information Pack age [EIP], GDP and GMP Audit Guides) and and t wo new guides (EIP Sustainability and GDP How To Guide) in 2022. I n a d d i t i o n , i n 2 0 2 1 I P E C - Americas members published seven a r t ic l e s i n ph a r m a c e ut ic a l t r a d e journa ls (Pharmaceutical Technolog y [" Novel E xc ipients a nd Add it ives a n d P r o c e s s A i d s " ] , Ta b l e t s & C a p s u l e s [ " I P E C - A m e r i c a s C elebrate s 3 0 Yea r s"], O utsou rced Pharma [three-part series on qual- it y b y d e si g n], a nd Inte r n a t i o n a l Journal of Biological Macromolecules [rebuttal to published article on car- boxymethyl cellulose]). STANDARDS DEVELOPMENT AND BEYOND Developing industr y standards was an important focus for the Parenteral Dr ug Association (PDA) in 2021. The organization has published two sets of g u ida nce so fa r t h is yea r: ANSI/PDA Standard 04-2021 Phage Retention Nomenclature Rating for Sma l l a nd La rge Vi r us-Retent ive F i lters a nd A NSI / PDA Sta nda rd 0 5-2 0 21 C on s e n s u s Me t h o d fo r R a t i n g F i lt e r s fo r My c o p l a s m a . B i o P h a r m I n t e r n a t i o n a l a s k e d Richard Johnson, CEO and President of PDA about these and other activi- ties the organization has planned for the coming months and the new year. BioPharm: What initiatives did PDA develop in 2021? Johnson (PDA): In response to t h e C OV I D -19 p a n d e m ic , P DA carried forward several initiatives to assist members and the industr y at large, including: • O p en i n g a c c e s s to t he on l i ne m e m b e r s h i p m a g a z i n e , P D A Letter, to nonmembers. • Accelerating the publication of s e ver a l tec h n ic a l rep or t s , su r- v e y s , a n d p o i n t s -t o - c o n s i d e r documents. • Fo r m a t i o n o f a 1 5 - m e m b e r i n t e r n a t i o n a l l y d i v e r s e C OV I D -1 9 P a n d e m i c Ta s k F o r c e . T h i s g r o u p d e v e l - o p e d a s e r ie s of w e bi n a r s on r e l e v a n t t o p i c s l i k e r e m o t e assessments and inspections, or r e s p on s e to p a n d e m ic-r e l at e d regulatory guidance, such as the US F DA Guidance for Indust r y: Planning for the Ef fects of High Absenteeism to Ensure Availability o f M e d i c a l l y N e c e s s a r y D r u g Products (March 2021). Regulatory Sourcebook Industry Perspectives BioPharm International asked Susan J. Schniepp, dis- tinguished fellow at Regulatory Compliance Associ- ates, about recent trends in regulations. BioPharm: With FDA suspending facility inspections in 2020 because of the pandemic, has the agency been more focused on specific t ypes of current good manufacturing practice (CGMP) violations at the manufacturing facilities they have inspected in the past year? Schniepp: I don't think the agency's focus on CGMP violations changed due to the pandemic. I think they are still focusing on investigation, supplier qualification, and adequate [standard operating procedures] SOPs. I do think the agency will ramp up efforts to evaluate a company's quality culture and the robustness of the quality management system (QMS). Companies that can demonstrate they have a robust quality culture and a quality management system that drives continual improvement, have little to worry about when inspections ramp up to pre-pandemic activity. BioPharm: What are the top CGMP violations found during FDA inspections that pharmaceutical manufacturers should be alert to? Schniepp: The top violations that still seem to dominate are procedures (SOPs) not being followed/ not in writing and incomplete investigations. These issues continue to plague the industry as in past years. The fact that the industry continues to struggle with these two observations indicates a lack of a robust QMS. I believe the main emphasis in inspections will continue to focus on QMS, as these issues resulting from supply chain disruption that emerged during the pandemic persist. One element of the QMS that I believe will be the focus of inspections is a firm's quality risk management plan. BioPharm: Do you see a trend in the topics FDA is choosing to publish guidance documents on? Schniepp: There have been a number of guidance documents issued in response to the pandemic. I am not sure I would call it a trend more than a response to an extraordinary circumstance. I think the agency should be commended for developing these guidances in such a timely manner. I anticipate any trends moving for ward will focus on updating ICH documents, so they reflec t current industr y practice. —Susan Haigney Trends in Biopharma Regulations