title: [Certification of suitability of monographs of the European pharmacopoeia].
abstract: In April 1994, t he European Pharmacopoeia Commission set up a new procedure for the "Certification of Suitability of Monographs of the European Pharmacopoela" to deal with the changing requirements of the licensing authorities and the growth of international trade, notably as regards raw materials to be used in the manufacture of medicines. This procedure was the result of extensive collaboration between the licensing authorities of the European Union and the other parties to the European Pharmacopoeia Convention, and it enables a manufacturer of a raw material for pharmaceutical use to demonstrate that the purity of their substance is suitably controlled by the monograph of the European Pharmacopoeia; this demonstration is now required by the guideline on "Requirements in Relation to Active Substances" published in Volume 3A of the Rules Governing Medicinal Products in the European Union. Initially set up in response to problems with impurities of synthesis and residual solvents that can vary from one manufacturer to another, the procedure has gradually been extended to a very wide range of products including products of fermentation and, more recently, products with risk of transmitting agents of animal spongiform encephalopathies.
authors.affiliation: 226 avenue de Colmar, BP 907, F67029 Strasbourg Cedex 1, France.
authors.forename: A
authors.initials: A
authors.lastname: Artiges
mesh_terms: D002568:Certification; D004340:Drug Contamination / Q000331:legislation & jurisprudence / Q000517:prevention & control; D004345:Drug Industry / Q000592:standards; D005060:Europe; D010602:Pharmacopoeias as Topic / Q000592:standards*; D011643:Publishing / Q000592:standards*