👁️ เข้าชม 4
Thailand’s National Vaccine Institute (NVI), together with the Thailand vaccine and biological products quality assurance and quality control (QA/QC) network, organised a hybrid conference under the topic “Trend of Quality Control along Manufacturing Process” during 28-29 April 2022.
The schedule included a site visit of National Pharmaceutical Facility (NBF) Unit 4 at King Mongkut’s University of Technology Thonburi (KMUTT) in Bang Khun Thian district, Bangkok.
Conference participants were welcomed by Dr Nakorn Premsri, Director of National Vaccine Institute (NVI). Dr Supaporn Phumiamorn, Chairperson of the Thailand vaccine and biological products quality assurance and quality control network, made opening remarks. Over 370 participants joined the online conference.
“Since COVID-19 started in Thailand in early 2020, the Ministry of Public Health together with network agencies has been doing its best to help Thailand get through the pandemic-related crisis,” said Dr Supaporn. “Thailand has continuously conducted research and development into various kinds of COVID-19 vaccines and other biological products.”
Honoured by vaccine and biological experts and other distinguished speakers, the conference covered topics including: PICs GMP Annex 1 revision to be released mid-year 2022, Characterisation of Biological Products; ICH Q8 Pharmaceutical Development; ICH Q9 Quality Risk Management & ICH Q10; Pharmaceutical Quality System and Application in Product Development, and; Monitoring and Control of GMP Facilities.
The conference discussed further about quality control at each COVID-19 vaccine production stage. Manufacturers spoke of their visions and addressed alternative experimental approaches to reduce animal use in biopharmaceuticals studies. Experiences and knowledge were exchanged among researchers and manufacturers in the field of vaccine quality control and assurance.
In the afternoon of 29 April, NVI executive committee members, together with vaccine and biological product manufacturers and representatives of the Institute of Biological Products under supervision of the Department of Medical Sciences, visited the National Pharmaceutical Facility (NBF) Unit 4 at King Mongkut’s University of Technology Thonburi (KMUTT) in Bang Khun Thian district, Bangkok. The advanced facility’s single use system produces high quality vaccines with production capacity of up to 2,000 litres per round. The facility is anticipated to officially start vaccine manufacturing services in 2023.
The participants also visited the Biopharmaceutical Characterization Lab (BPCL) at NBF comprising four operational rooms: Protein Characterisation; Biologic Testing; Microbial & Cell Line Characterisation, and; Viral vector Characterisation. Some parts of the lab are now open to run tests for vaccines. Services for approximately 25 parameter-analysis and qualification testing of drugs and vaccines is expected to start in 2023.
Both successful projects are part of expedited COVID-19 vaccine availability planning in line with the Royal Decree that empowers the Ministry of Finance to give loans for social and economic recovery during the wake of the pandemic approved by the Government for NVI.
This marks a significant step in laying a strong foundation for vaccine and biological production and qualification testing for domestic development of vaccines and biological products going forward. It will reduce costs and waiting times involved in hiring vaccine-making factories abroad to run tests on vaccine quality and certification.
The visitors paid close attention to building cooperation with KMUTT to enhance the capabilities on self-reliance and strengthen the country’s healthcare security with respect to vaccines and biological products. In line with the National Vaccine Strategic plan and related policies, focusing on criteria and international standards for quality assurance and control of vaccines and biological products.
Reference: Bangkokpost.com