1st ASEAN Overview Workshop on GMP for BIOLOGICALS/BIOSIMILARS 2018

5 August 2018, Da Nang, Vietnam

GaBI organized the 1st ASEAN Overview Workshop on GMP for BIOLOGICALS/BIOSIMILARS on 5 August 2018 in Da Nang, Vietnam in collaboration with the ASEAN (Association of Southeast Asian Nations) ACCSQ-PPWG, and with strong support from the World Health Organization (WHO) experts and consultants.

The 1st ASEAN Overview Workshop on GMP for BIOLOGICALS/BIOSIMILARS is an introductory and interactive workshop on good manufacturing practice (GMP) inspection framework for biologicals/biosimilars based on PIC/S or other equivalent international GMP standards for all members of the ASEAN Joint Sectoral Committee (JSC) on GMP Inspection, any other invited ASEAN GMP inspectors, as well as other reviewers from the ASEAN ACCSQ-PPWG Member States: Brunei Darussalam, Indonesia, Lao PDR, Malaysia, Philippines, Singapore, Thailand, Vietnam; together with academics and regulators to discuss and exchange information with experts from Asia and Europe. Forty-six participants, speakers included, attended the workshop.

This educational workshop intends to heighten understanding of the GMP inspection framework for biologicals/biosimilars based on 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 overview workshop to engage in active discussion concerning WHO GMP for biological products; cell bank system; fermentation; purification; cell isolation/extraction; pharmaceutical quality and risk management; validation methods; batching and storage; data integrity; WHO recommendation/production processes of cell substrates; and to identify concerns/challenges and knowledge gaps where (intensive/further) training may be required.

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 identify inspectors’ concerns towards GMP of biologicals/biosimilars.

A meeting report meeting report of this workshop has been published in GaBI Journal.

You can download the speakers’ presentations of this educational workshop:

Welcome and workshop objectives by Chair of the ASEAN Joint Sectoral Committee on GMP Inspection

Newly revised WHO GMP for biological products

Characterization and testing of animal cell substrates used for production of biologicals

Fermentation: fundamentals, control of source materials and cell culture conditions

Purification of vaccines and biologicals

Harvest process in commercial biologicals manufacturing

How to build an effective pharmaceutical quality system

Validation of viral removal/inactivation and bioanalytical methods

Batching and storage of bulk biological products

Data Integrity from an inspector’s point of view