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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.
The requirement for QP oversight has been extended to material for use in clinical trials since the introduction of EU Directive 2001/20/EC. 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 ...
The European regulatory authorities update the database continuously and expect it to grow extensively over the next few years as more “GMP certificates are imported each year.” [2] The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer.
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]
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
A stalker who "scared the life" out of a woman in his "relentless" pursuit of her has been jailed. Tyson Junior Miller, 37, of Hill Rise, Chippenham, turned up at the house of his victim and sent ...
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]).
Iran has confirmed the arrest of Italian journalist Cecilia Sala, state news agency IRNA said, citing the Iranian Ministry of Culture.