(1999; 168 pages) [Spanish]
2.1 Quality specifications for drug substances and dosage forms
The Committee received a report of a worldwide survey on the use of The international pharmacopoeia, and noted with satisfaction its widespread use in virtually all areas of the world. The report clearly indicated that The international pharmacopoeia plays a major role in defining the specifications of pharmaceutical products. It also provides a valuable tool in the quality assurance of imported products. It was suggested that manufacturers in exporting countries should be encouraged to include an indication of compliance with The international pharmacopoeia, wherever appropriate, in the product information, to make it easier for developing countries to check the quality of imported products.
The Committee was informed that Volume 5 of The international pharmacopoeia would shortly be submitted for publication. Monographs for Volume 6 were in preparation. In cases where there was insufficient information from official sources, the monographs would be prepared with the assistance of pharmaceutical manufacturers.
Texts on general methods to be included in The international pharmacopoeia were approved for bacterial endotoxins, the visual inspection of particulate matter and extractable volume for parenteral preparations, and guidelines on the microbial purity of pharmaceutical preparations. It was noted that revision of some pharmacopoeial monographs would be necessary to replace the test for pyrogens with that for bacterial endotoxins. It was also suggested that guidelines for using this test might be developed. It was emphasized that the test for visual inspection of particulate matter was intended to provide a simple procedure for the independent assessment of parenteral solutions; it was not intended for use by a manufacturer for batch release purposes, which require more rigorous controls.
The Committee confirmed the need to continue to base the requirements of The international pharmacopoeia on reliable but simple methods widely available in small control laboratories. While recognizing the need to continue with work on new monographs, in particular to cover drugs included in the WHO Model List of Essential Drugs (1), both for pharmaceutical substances and dosage forms, the Committee agreed that revision of published texts was also important.
The Committee agreed that, as a matter of high priority, collaborative work should be carried out to establish dissolution requirements, details of test conditions, and acceptance criteria for the monographs previously identified as needing such requirements. It was confirmed that this selective approach was appropriate. Other aspects of dissolution testing were discussed in relation to multisource pharmaceutical products (see section 7.3).
It was suggested that monographs on important excipients in addition to the ones published in Volume 4 (2) should be prepared for inclusion in The international pharmacopoeia.