(1999; 168 pages) [Spanish]
5.3 Relationship between pharmacopoeial requirements and manufacturers' internal specifications
Members of the Committee generally endorsed the need to develop a document explaining the role of pharmacopoeial requirements and their place in the overall system of quality assurance. Provision of such interpretative guidance was intended to facilitate dialogue between manufacturers and regulatory authorities.
WHO might consider whether it could offer more detailed guidance on the development of manufacturers' specifications for established products, once ICH had finalized corresponding guidelines on new chemical substances and products of biotechnology.