18 December 2019, Jakarta, Indonesia
GaBI organized the 2nd ASEAN Educational Workshop on GMP FOR BIOLOGICALS/BIOSIMILARS on 18 December 2019 in Jakarta, Indonesia in collaboration with the ACCSQ-PPWG (ASEAN Consultative Committee for Standards and Quality-Pharmaceutical Product Working Group), and with strong support from the World Health Organization (WHO) experts and consultants.
The 2nd ASEAN Educational Workshop on GMP FOR BIOLOGICALS/BIOSIMILARS is an in-depth workshop on good manufacturing practice (GMP) inspection framework for biologicals/biosimilars based on WHO, PIC/S and EU GMP standards for all members of ACCSQ–PPWG of ASEAN Member States: Cambodia, Indonesia, Lao PDR, Malaysia, Phil¬ippines, Singapore, Thailand, Vietnam; together with inspectors and regulators to discuss and exchange information with experts from Asia and Europe. Forty-three participants, speakers included, attended the workshop.
This second-level knowledge workshop intends to provide in-depth understanding of the GMP inspection framework for biologicals/biosimilars based on WHO, PIC/S or other equivalent international GMP standards. Representatives from ASEAN JSC on GMP Inspection and ACCSQ-PPWG who are GMP inspectors and reviewers who deal with biological and biosimilar products, joined together with expert speakers of this educational workshop to engage in active discussion concerning WHO GMP for biological products; cell bank system; purification; validation of viral removal; viral safety; bioanalytical method validation; sterile manufacturing, and next generation biomanufacturing technologies; as well as to identify concerns/challenges and knowledge gaps where (intensive/further) training may be warranted.
The workshop focuses on GMP standards and information/knowledge required for effective and quality GMP inspection for biological products. Parallel discussion sessions were held to discuss issues generated from the 1st ASEAN GMP Overview Workshop to identify inspectors’ concerns towards GMP of biologicals/biosimilars.
You can download the speakers’ presentations of this educational workshop:
Current state of development of GMP for biologicals in ASEAN
Newly revised WHO GMP for biological products
Purification of vaccines and biologicals
Validation of viral removal and inactivation
Viral safety of biotechnology-based products
Bioanalytical method validation
Sterile manufacturing based on Annex 1 of the PIC/S-EU GMP Guide
Transforming operations with next generation biomanufacturing
Contact us for further information.
