1st ASEAN overview workshop on GMP for biologicals/biosimilars 2018 - Report

Introduction: The Association of Southeast Asian Nations (ASEAN) Overview Workshop on GMP for Biologicals and Biosimilars was co-organized with the Generics and Biosimilars Initiative (GaBI). This meeting was intended to improve the understanding of the good manufacture practice (GMP) inspection framework for biological (and biosimilar) drugs among ASEAN countries. Methods: The workshop was held on 5 August 2018 in Da Nang, Vietnam. It was attended by 46 participants including representatives from the World Health Organization (WHO), ASEAN Joint Sectoral Committee (JSC) on GMP Inspection, ACCSQ-PPWG (ASEAN Consultative Committee for Standards and Quality-Pharmaceutical Product Working Group), as well as a range of other experts and consultants. It included a series of presentations, Q& A sessions and parallel group discussions. Results/Processes: Topics discussed included the revised WHO GMP for biological products; cell types used for biological production; the fundamentals of fermentation and purification; the harvesting process; pharmaceutical quality systems; virus removal and inactivation technologies; batching of bulk biological products; data integrity; and the latest WHO recommendations on cell substrates. Conclusion: The meeting highlighted many important issues surrounding GMP for biological and biosimilar drugs manufactured and/or imported into ASEAN Member States (AMS). Overall, the meeting helped to clarify WHO's requirements for GMP production of biological drugs and how manufacturers can ensure these standards are met to ensure their product is safe, effective and of high quality. It was an important step forward as the first meeting of its kind for ASEAN countries.