Introduction: The Association of Southeast Asian Nations (ASEAN) Overview Workshop on GMP for Biologicals and Biosimilars was co-organised with the Generics and Biosimilars Initiative (GaBI). This meeting intended to improve understanding of the 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 JSC on GMP Inspection, ACCSQ-PPWG, as well as a range of other experts and consultants. It included a series of presentations, Q&A sessions and parallel group discussions.
Results: The workshop included discussion on the revised WHO GMP for biological products; cell types used for biological production; the fundamentals of fermentation and purification; the harvest process; pharmaceutical quality systems; viral removal and inactivation; 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 in ASEAN countries. 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.
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