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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 ...
EudraLex, Volume 4, Chapter 1) The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years' experience working in pharmaceutical manufacturing operations, and has passed examinations attesting to his or her knowledge. The requirement for QP oversight has been ...
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.
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]).
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies.Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
The Ministry of Foreign Affairs and International Cooperation is the government ministry of Guyana responsible for directing the nation's external relations and the operations of its international diplomatic missions. Hugh Todd has directed the ministry as Minister of Foreign Affairs since August 2020. [1]
Founded in 1958, PhRMA lobbies on behalf of pharmaceutical companies. [ 2 ] [ 3 ] PhRMA is headquartered in Washington, D.C. [ 1 ] The organization has lobbied fiercely against allowing Medicare to negotiate drug prices for Medicare recipients, [ 4 ] and filed lawsuits against the drug price provisions in the Inflation Reduction Act . [ 5 ]
In 1983 the FDA published a guide to the inspection of Computerized Systems in Pharmaceutical Processing, also known as the 'bluebook'. [5] Recently both the American FDA and the UK Medicines and Healthcare products Regulatory Agency have added sections to the regulations specifically for the use of computer systems.