"We make sure that Bio Farma products are safe and are of good quality, both for the domestic and international markets," BPOM head Lucky Slamet said here on Wednesday.
He made the statement after delivering a presentation on the prequalification programme of World Health Organization (WHO) at the 13th meeting of Developing Countries Vaccine Manufacturers Network (DCVMN).
According to Slamet, BPOM plays a critical role in ensuring that the quality of all Bio Farma products meet the WHO's prequalification requirements, so the products can be marketed globally.
He said the WHO appointed BPOM to be in charge of guaranteeing the quality of Bio Farma products.
"However, to obtain that authorization, we had to go through a series of assessments conducted by the WHO periodically for two years. BPOM passed the last assessment in July 2012," Slamet stated.
"There are five main tasks for the BPOM as the quality controller of Bio Farma products, namely inspection, product testing, checking of laboratory access for quality control, product safety monitoring, and production process monitoring," he continued.
Besides, Slamet added, the monitoring was carried out in two main phases: pre-production and post-production.
"At the pre-production phase, we evaluate the efficacy, safety and quality of the products. At the post-production phase, we observe the quality of the products. For instance, we will check whether the vaccine is stable or not, and whether there are any side effects after use," he noted.
Slamet said 11 products of Bio Farma have received WHO prequalification.
"Several other products of Bio Farma are expected to receive WHO prequalification next year," he added.
(Y012/KR-BSR/F001)
Editor: Aditia Maruli Radja
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