ISPE – The International Society for Pharmaceutical Engineering is the world’s largest non-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle.
NA-DFC – National Agency of Drug and Food Control of the Republic Indonesia, The National Agency of Drug and Food Control (NA-DFC) is a non-departmental government institution which the duties of detecting, preventing and controlling traditional medicines, cosmetics and complementary products in order to protect the consumers security and health in the country and overseas. It operates based on Presidential Decree No. 166 of the year 2000 which is responsible directly to the President and builds policy coordination with the Minister of Health and Social Welfare.
PICScheme – The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive co-operation in the field of GMP.
FDA Organization – FDA is an agency within the Department of Health and Human Services. The FDA’s organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobbaco, Foods, Global Regulatory Operations and Policy, and Operations.
ICH – International Conference on Harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drup registration.