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The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the ...
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
In countries that are part of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the same role may be termed responsible person (RP) or authorized person (AP).
Pharmaceutical Inspection Cooperation Scheme: GMP Guides; World Health Organization GMP Guidelines; European Union GMP Guidelines; US CFR Title 21 parts 210 (GMP, general), 211 (GMP, finished pharmaceuticals), 212 (GMP, positron emission tomography drugs), 225 (GMP, medicated feeds), 226 (GMP, type A medicated articles).
The firms that are overdue for safety and quality inspections represent about 42% of the 4,700 plants that are currently registered to produce drugs for the U.S. and previously underwent FDA ...
Draft laws, regulations and rules and policy plans on the administration and supervision of food (including food additives and health food, the same below) safety, drugs (including traditional Chinese medicines and ethno-medicines, the same below), medical devices and cosmetics; formulate normative documents, and facilitate the establishment and implementation of the food safety responsibility ...
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme; Validation (drug manufacture) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) European Medicines Agency (EMA) European Federation of Pharmaceutical Industries and Associations (EFPIA)