Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part
1. Introduction:
1.1 Background:
The Procedure for prequalification of pharmaceutical products (1) outlines the procedure and considerations for the process undertaken by WHO in providing United Nations agencies with advice on the acceptability, in principle, of pharmaceutical products for procurement by such agencies. It states:
‘‘This activity of WHO aims to facilitate access to priority essential medicines that meet WHO recommended norms and standards of acceptable quality.’’
As mentioned in WHO Technical Report Series, No. 961 (1), in submitting an expression of interest (EOI) for product evaluation, the applicant should send a product dossier (PD) to the WHO focal point (together with the other data required), in the format specified in the WHO guidance documents on submitting product data and information.
Through the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) process, considerable harmonization has been achieved on the organization for the Quality module of the registration documents with the issuance of the Common technical document (CTD) – quality (ICH M4Q) guideline (2). This format, recommended in the M4Q guideline for the quality information of registration applications, has become widely accepted by regulatory authorities both within and beyond the ICH regions.
The current document provides recommendations on the quality information for active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) that should be submitted to WHO to support PDs.
Alternative approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification. It is also important to note that the WHO Prequalification of Medicines Programme may request information or material, or define conditions not specifically described in this guidance, in order to adequately assess the quality of a pharmaceutical product.
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Table of Contents
3.1 Module 2.3: Quality
overall summary – product dossiers (QOS-PD)
3.2 Module 1.4.2:
Quality information summary (QIS)
4.1 Table of contents of
Module 3
3.2.S Drug substance (or
active pharmaceutical ingredient (API))
3.2.P Drug product (or
finished pharmaceutical product (FPP))
Recommendations for
conducting and assessing comparative dissolution profiles
Product quality review
requirements for established multisource products
WHO TRS (Technical Report Series) 970, 2012 Annex 4:
