FDA Adopts 'Good Manufacturing Practice' System

Manila Bulletin, December 26, 2018 | Go to article overview

FDA Adopts 'Good Manufacturing Practice' System


By Roy Mabasa

The Food and Drug Administration (FDA) of the Philippines is currently implementing Good Manufacturing Practice (GMP) Inspectorate to ensure safety in drugs, including vaccines, and enhance skills of its local inspectors.

This came after personnel from FDA recently undertook a series of training under the Japan International Cooperation Agency (JICA) to observe manufacturing facilities for vaccines and testing systems in Japan.

"We understood the stringent regulations and well-defined functions of the Japanese government on vaccines. They also implement quality control guidelines to ensure that vaccines are safe," said Geraldine Dimapilis, Food and Drugs Regulation Officer from the FDA Field Regulations Operations Office who was one of the participants in the JICA-backed training program.

Since the Philippines relies on procurement when it comes to vaccines, Dimapilis said the training in Tokyo showed the importance of collaborating with academe when it comes to inspecting the quality of vaccines.

Another participant, Kharlo de Guzman from FDA Common Services Laboratory, noted that they also learned about Japan's so-called relief system that provides benefits from health damage such as diseases and disabilities from pharmaceuticals and adverse effects following vaccinations.

The training called 'Strengthening the National Regulatory Authorities for Vaccine's Quality and Safety' is part of JICA's Knowledge Co-Creation Program (KCCP) that aims to share Japan's experiences and know-how on specific development areas with partner countries. …

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