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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.
Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated activities and defines Computer System Validation Elements [2]
The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer. One can search by the “company name, location, or certificate number and find details on the types of products or activities that the company conducts and the date of the most recent GMP inspection.” [ 3 ]
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]).
Image source: The Motley Fool. Bank of America (NYSE: BAC) Q4 2024 Earnings Call Jan 16, 2025, 11:00 a.m. ET. Contents: Prepared Remarks. Questions and Answers. Call Participants
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 agency began its review into the class of weight loss and diabetes drugs, known as GLP-1 receptor agonists, last July after Iceland's health regulator flagged three cases of patients thinking ...
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