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Guidance Documents

Guidance Documents

Three principal types of guidance documents can be consulted by manufacturers seeking prequalification:

Technical Report Series documents approved by ECSPP are of significant interest and value for manufacturers (and also for regulators and procurers). But the ECSPP approval process can be lengthy. To help them respond effectively to, for example, demands for new products or for new formulations of existing products, or to enhance the quality of their manufacturing process, through incorporation of pharmaceutical technology developments, manufacturers often require guidance within a much shorter timeframe. WHO medicines prequalification staff  therefore work closely and intensively with pharmaceutical experts to develop guidance, as needed, and promptly. In so doing it both facilitates and eases the technical burden associated with quality medicines manufacturer, and expands the range of appropriate products for meeting treatment needs. In fact, much of the guidance so developed ― together with feedback from manufacturers and regulators ― forms the basis of guidance documents submitted to ECSPP, thereby also facilitating ECSPP processes.

Applicants for prequalification – be this in relation to active pharmaceutical ingredients, finished pharmaceutical products or quality control laboratories – should consult both relevant TRS and medicines prequalification guidance documents.

The International Pharmacopoeia can be consulted for recommended procedures for analysis and specifications for the determination of pharmaceutical substances and dosage forms.