Prequalification of Active Pharmaceutical Ingredients - Invitations for Expressions of Interest
To manufacturers of medicinal products
The vision of the WHO Prequalification of Medicines
Programme (PQP) is of a world in which good-quality
medicines are available to all those who need them. PQP
facilitates access to good-quality medicines through
assessment of products and inspection of manufacturing
good-quality active pharmaceutical ingredients (APIs) are
vital to the production of good-quality medicines, PQP has
started a project to prequalify APIs.
APIs that meet
assessment criteria will be added to the
WHO List of
Prequalified Active Pharmaceutical Ingredients.
Manufacturers and National Regulatory Authorities (NRAs)
can use the List to help them identify APIs of
assured quality, while UN agencies and others can use the List
the information found on the WHO List of Prequalified
The issuing of an invitation to submit an
expression of interest (EOI) is the first step in the
prequalification process. Each invitation is developed in
consultation with WHO disease programmes, other UN agencies
(including UNAIDS and UNICEF) and UNITAID. The 1st
Invitation to manufacturers of APIs to submit a request for
an evaluation of an API was issued in October 2010.
The current EOI is:
In applying for evaluation of an API,
manufacturers are requested to submit a covering letter,
application form, API master file (APIMF), site master file
(SMF), and evidence of current GMP certification to PQP.
Thereafter, PQP will undertake a comprehensive evaluation of
the APIMF and review the GMP status of the manufacturing
site(s). In some cases, PQP will request additional
information and may also inspect the manufacturing site(s).
For information on applying for API prequalification
please study carefully the section: