PDA Letter Article

Happenings at the 2021 PDA Singapore Chapter Annual General Meeting

by Richard Chai, STERIS Corporation, Priyabrata Pattnaik, Merck Pte. Ltd., and Bruce Loxley, GSK

A screengrab of a Zoom meeting, lead by Bruce Loxley at the top of the screen, featuring photos of the Singapore Chapter Board.

The PDA Singapore chapter Annual General Meeting (AGM) was held on 25 Feb 2021. The virtual AGM started with PDA Singapore Chapter President, Bruce Loxley, giving an introduction on the PDA Singapore chapter events held last year. Despite a challenging year due to numerous restrictions, there were four successful symposiums and a PDA Singapore Conference. The Chapter collaborated with the PDA Australia and India Chapters on two of the symposia, benefiting wider audiences.

For the first time, there were three life sciences industry webinars on the technical and soft skills required for the life science students from Nanyang Technological University and National University of Singapore. The webinars covered an overview of aseptic manufacturing, followed by an introduction to PDA, experience sharing of a young professional, and lastly interactive sessions with students. The Chapter will continue to engage with university students, the future young professionals, to better prepare them for a successful career in the life science industry.

Chapter business was discussed first, including Singapore Chapter Treasurer Christina Chen’s update on the financial results of FY2020.

The first webinar session was titled, “Impact of COVID-19 on Health Science Authority’s Audit,” presented by Jessica Teo, Division Director, Audit and Licensing Division, Health Sciences Authority. Teo is from the Audit and Licensing team in HSA and has extensive experience in conducting GMP audits. She shared the GMP inspection trends, followed by an overview of the risk-based approach that involves hybrid, virtual and desktop assessment to ensure continuous compliance, in line with the requirements on the various phases of restrictions during COVID-19 pandemic.

Teo also elaborated on the steps required in full virtual inspection, hybrid inspection and desktop assessment (pre-inspection, inspection, post-inspection, and closure). Lastly, she touched on the challenges of virtual inspections and its potential mitigations. Her insights into the audit challenges and mitigation measures in various mode of audit has been extremely beneficial to all of us who are involved in audits during this challenging time.

Richard Johnson, President and CEO of PDA, then gave an insightful update on the future challenges and strategic plans for PDA Asia Pacific. Strategic plans include focusing on people by growing membership to serve a broader audience, and to make the knowledge and network base more accessible. Asia Pacific has 18% of PDA global membership, and this is also a significant region for biological manufacturing.

Richard said he hoped to see more involvement of technical experts in this region volunteering for PDA activities such as technical or non-technical advisory boards, contribute articles to the PDA Letter and the PDA Journal of Pharmaceutical Science and Technology, or knowledge sharing through participation in conferences or task force members.

The third webinar during the AGM was called, “Overview of External CMC Discussions Related to COVID-19 Vaccines,” presented by Cristiana Campa from GSK vaccines. She talked about the various stages of vaccine development. This excellent technical presentation enabled the audience to have a better understanding on the complex vaccine development work and possibilities of streamlining the regulatory framework considering the pandemic context.

Emily Cheah, President-Elect of PDA Singapore Chapter, provided the closing remarks.

The board members of PDA Singapore Chapter wish everyone can emerge stronger in the year ahead and hopefully can meet everyone in person in the next AGM.

About the Authors

Richard ChaiRichard Chai is a Technical Service Manager in the Life Sciences Division of STERIS Corporation. He currently provides global technical support related to process equipment cleaning and contamination control in cleanrooms. Richard has 20 years of pharmaceutical industry experience in manufacturing, validation, consultancy and technical support. He has been a volunteer at PDA Singapore Chapter since 2017.

Bruce LoxleyBruce Loxley performs regional and global auditing of GSK Vaccines and third party provider sites and functions focusing on AsiaPac. Bruce has 29 years in the Pharma and Vaccines businesses, variety of roles in Validation and Compliance in both Drug Substance and Drug Product Manufacturing in UK, France and Singapore. Bruce has been a PDA Singapore Chapter member since 2014. Since February 2020 he has been PDA Singapore Chapter President. Bruce holds a Bachelor in Applied Science (Applied Chemistry) from Curtin University of Technology, Perth, Australia.

Priyabrata PattnaikPriyabrata Pattnaik is currently Director of End-to-End Solutions at Merck overseeing CDMO business activities in Asia Pacific. He Previously was Head of Asia Pacific Biologics Operations of Biosafety testing facility in Singapore. Dr. Pattnaik has 21 years in the Life Science sector dealing with vaccines and therapeutics, in variety of local, continental, and global roles in R&D, Bioprocessing Applications, Technical Support, Market Strategy, Sales Development & technical operations based out of India and Singapore.