According to the disease surveillance data collected by the Central Epidemic Command Center (CECC), the number of pandemic influenza A (H1N1) cases has continued to increase.Vaccination is the single most effective way to prevent pandemic influenza A (H1N1).Since Adimmune Corporation is manufacturing the vaccine, the Department of Health (DOH) has assigned personnel from the Bureau of Food and Drug Analysis and the Bureau of Pharmaceutical Affairs to monitor and make sure the manufacturing process of the vaccine accords to Good Manufacturing Practice (GMP) standards.

It has been years since DOH started promoting the adaptation and adoption of Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice (GMP) standards among local pharmaceutical manufacturers. According to the regulations to implement PIC/S GMP standards promulgated by DOH in December 2007, establishing and expanding pharmaceutical factories requires adaptation and adoption of PIC/S GMP standards.Hence, DOH inspected the pandemic influenza A (H1N1) vaccine manufacturing site set up by Adimmune Corporation according to PIC/S GMP standards.On May 13 and 14, 2009, personnel from the Bureau of Food and Drug Analysis and the Bureau of Pharmaceutical Affairs were sent to Adimmune Corporation to conduct GMP inspection of the seed virus subculture room.Further, beginning August 6, 2009, personnel from the Bureau of Food and Drug Analysis and the Bureau of Pharmaceutical Affairs have been sent to Adimmune Corporation to conduct GMP software inspection of the production of the pandemic influenza A (H1N1) vaccine in order to ensure the quality and safety of the vaccine.

On the other hand, prior to the completion of the third batch of pandemic influenza A (H1N1) vaccine, DOH will assign experienced GMP inspection personnel to Adimmune Corporation to supervise the entire production process till the 5 million doses ordered have been produced.Simultaneously, the personnel will collect samples of the vaccine for further testing at the national laboratory to expedite the inspection and sealing process of the vaccine.