Specifications for the quality control of pharmaceutical Preparations

Specifications for the quality control of pharmaceutical Preparations - Praca Zbiorowa

The Committee discussed the merits of introducing modern analytical techniques. It was recognized that such new techniques could sometimes be more sensitive, rapid and robust, as well as potentially less expensive. However, there was still a need for less advanced methods. It was proposed that information on both types of methods might be provided in parallel, with the newer techniques indicated as the first choice and the less advanced methods as alternatives. Thus, where resources permitted, the more technically advanced methods should be used. However, the possibility of using the less advanced alternative methods to check compliance with pharmacopoeial specifications, where necessary, would increase the usefulness of The international pharmacopoeia. In making these proposals, the Committee emphasized the importance of compliance with pharmacopoeial requirements as part of the overall strategy for detecting counterfeit and substandard products (5). The introduction of alternative methods would require careful presentation, and it was recommended that a statement should be inserted in Volume 5 of The international pharmacopoeia to introduce the concept, together with the use of appropriate headings. This would reiterate that implementation of The international pharmacopoeia was the responsibility of national drug authorities.