Quality assurance — general topics 88.1 Starting materials for pharmaceutical products: control andsafe trade 88.2 Model certificate of analysis for use in trade and procurement 98.3 Screening tests for antimalarials and antituberculosis drugs 98.4 Tuberculosis programme — fixed-dose combinations 98.5 Comparator products for equivalence assessment ofinterchangeable multisource (generic) products 108.6 Measures to combat counterfeit drugs 108.7 Information on general publications 119.
Nomenclature and computerized systems 119.1 International Nonproprietary Names for pharmaceuticalsubstances 11.iv9.2 Regulatory information systems 129.3 Drug quality assurance terminology 1210.
Essential drugs were recog-nizedas a high priority, but WHO also needed to maintain all itsactivities concerned with drugs, including innovative products.
A cru-cialpart of the quality assurance programme was the network of 13WHO collaborating centres, whose activities included the verifica-tionof test methods, the establishment of reference materials, andtraining.
The introduction of alter-nativemethods would require careful presentation, and it was recom-mendedthat a statement should be inserted in Volume 5 of Theinternational pharmacopoeia to introduce the concept, together withthe use of appropriate headings.
This would reiterate that implemen-tationof The international pharmacopoeia was the responsibility ofnational drug authorities.2.2 Monographs for The international pharmacopoeia The Committee was pleased to note that a number of additionalmonographs for drug substances, pharmaceutical preparations (e.g.tablets) and excipients are nearing completion for inclusion in Theinternational pharmacopoeia.
It was proposed that information on both types of methods mightbe provided in parallel, with the newer techniques indicated as thefirst choice and the less advanced methods as alternatives.
Thus,where resources permitted, the more technically advanced methodsshould be used.
Because of the concern that exists regarding the controlof starting materials, a meeting was held in 1998 at which proposalswere made for a model certificate of analysis, and for expansion of the WHO Certification Scheme on the Quality of Pharmaceutical Prod-ucts Moving in International Commerce to include starting materials,as well as brokers and traders in such materials (3).
Efforts to enhancethe implementation of GMP and to create an awareness of the needto produce good quality products, as well as the preparation of train-ingmodules for GMP inspectors, were also proposed.
Regulatory issues 1210.1 Harmonization of regulatory requirements 12Acknowledgements 13References 15Annex 1List of available International Chemical Reference Substances 18Annex 2List of available International Infrared Reference Spectra 25Annex 3Good practices for national pharmaceutical control laboratories 27Annex 4Considerations for requesting analysis of drug samples 69Annex 5Basic elements of good manufacturing practices in pharmaceuticalproduction 73Annex 6Good manufacturing practices for sterile products 76Annex 7Guidelines on pre-approval inspections 94Annex 8Quality systems requirements for national good manufacturing practiceinspectorates 101Annex 9Guidelines on packaging for pharmaceutical products 119Annex 10Model certificate of analysis 157Annex 11Guidance on the selection of comparator pharmaceutical products forequivalence assessment of interchangeable multisource (generic) products 161Annex 12Guidelines on the use of International Nonproprietary Names (INNs) forpharmaceutical substances 181.v1.
Introduction The WHO Expert Committee on Specifications for Pharmaceutical Preparations met in Geneva from 31 May to 4 June 1999.
However, the possibility of using the less advancedalternative methods to check compliance with pharmacopoeialspecifications, where necessary, would increase the usefulness of Theinternational pharmacopoeia.