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The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.
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]).
Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics. Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7; Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The EPC contractor coordinates all design, procurement and construction work and ensures that the whole project is completed as required and in time. They may or may not undertake actual site work. EPC companies are often used in large-scale projects, such as power plants, refineries, chemical processing facilities, infrastructure projects, and ...
Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA). [ 4 ] [ 5 ] The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry , as well as indirect subsidy from member states, its stated intention to harmonise (but not ...
CDM 2007 was a result of an EU Directive 92/57/EEC (OJ L245, 26.8.92), [3] the 'Construction Sites Directive'. They came into force on 6 April 2007, and replaced a 1994 predecessor as amended in 2000 and 1996 Health and Safety regulations. [4]
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 ...