[The pharmacopoeia. An important pillar of drug safety].
The pharmacopoeia is an official collection of approved pharmaceutical standards. In addressing anyone who produces, distributes or controls medicinal products it comprises requirements on the quality of medicinal products and of the substances used to manufacture them. Moreover, it provides quality control methods. It is therefore an important component of the drug safety system and thus an instrument for patient and consumer protection. How ever, the trend to outsource the production of raw materials to countries outside Europe is often associated with altered production procedures and may have severe consequences. Unwanted side effects of medicinal products--caused by quality changes of the raw materials--may occur. However, this peril can be significantly reduced by consistently adapting the provisions of the pharmacopoeia to the evolution of the drug market.
Belz
S
S
Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany. s.belz@bfarm.de
D004340:Drug Contamination / Q000517:prevention & control; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control; D005060:Europe; D005858:Germany; D006801:Humans; D020416:Outsourced Services / Q000592:standards; D010602:Pharmacopoeias as Topic / Q000592:standards*; D011786:Quality Control