Pharmaceutical Testing
Organisations and their Roles
3. DRUG SAFETY, QUALITY AND EFFICACY – THE PHARMACOPOEIAS The main role of the Pharmacopoeias is to define the standards with which medicines must comply and the methods by which compliance will be adjudged. As with the regulatory groups, the leading Pharmacopoeias tend to be those of the European Union, Japan and the USA. a) European Pharmacopoeia This is published by the Directorate for the Quality of Medicines and Healthcare of the Council of Europe (EDQM). In the European Pharmacopoeia (Ph.Eur. ), the main information relating to a drug product is contained in the general monograph relating to the dosage form concerned (see “Monographs on Dosage Forms”). This normally gives a definition of the dosage form e.g. tablets,
together with notes as to its production and, where
A separate chapter, Pharmaceutical Dosage Forms <1151>, gives a general description and definition of the more common dosage forms together with the general principles
applicable, the test procedures, storage conditions and labelling requirements relevant to that type of product, with cross references to appropriate methods of testing e.g. Uniformity of Dosage Units (2.9.40). The EDQM is also responsible for“ Pharmeuropa ”, a quarterly publication which contains “Draft Monographs and General Texts for Comment” together with the latest news on “International Harmonisation”. b) United States Pharmacopeia Hitherto, the United States Pharmacopeia (USP) has adopted a similar approach to Ph.Eur. with details of the test procedures to be employed together with all of the other relevant information in product specific monographs with cross references to the appropriate methods of testing e.g. Uniformity of Dosage Units <905>.
in their compounding and manufacturing. However, in USP 38 the
Pharmacopeia has introduced a series of new chapters, <1> through to <5>, entitled General Requirements for Tests and Assays , which provide general information and the critical quality attributes applicable to the various dosage forms based on their route of administration (see Table on Page 11). The five chapters concerned detail the test procedures relevant to each dosage form, divided between those relating to product quality and those to product performance , with cross references to the methods of testing as appropriate.
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