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Guidelines on the implementation of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce
1. Introduction:
The World Health Organization (WHO) Certification Scheme on the quality of pharmaceutical products moving in international commerce (hereinafter referred to as the “Scheme”) is an international voluntary agreement to provide assurance to countries participating in the Scheme about the quality of pharmaceutical products moving in international commerce. The primary document of the Scheme is the certificate of a pharmaceutical product (CPP).
2. Background:
The Scheme has been in operation since 1969 (World Health Assembly resolution WHA 22.50) and was amended in 1975 (WHA 28.65), 1988 (WHA 41.18), 1992 (WHA 45.29) and 1997 (WHA 50.3) (1–5). In 2007, the Forty-second ECSPP discussed and identified a number of perceived problems with the operation of the Scheme (6).
In 2008, a WHO consultation was held to make recommendations for consideration during the Forty-third WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP), taking into account the WHO working document QAS/07.240 which contains key issues and possible action (7). The report of the consultation was the working document QAS/08.279 (8). In light of the changing environment, including the rapid globalization of the pharmaceutical manufacturing sector, coupled with changes in the make-up of both the regulators and the groups involved in procurement, the Forty-third ECSPP endorsed the following recommendations (9):
“1. The WHO Certification Scheme on the quality of Pharmaceutical products moving in international commerce should be revised.
2. The proposal for revision of the Scheme and modification of the guidelines should be discussed by the relevant WHO Governing Bodies – the Executive Board and the World Health Assembly – and in consultation with WHO’s Legal Counsel.
3. In the interim, a question and answer (Q&A) paper should be prepared on the function of the Scheme.”
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Table of Contents
7. Notifying and investigating a
quality defect
Appendix 1 Model certificate of a
pharmaceutical product
Appendix 2 Model batch certificate
of pharmaceutical products
Appendix 4 (Draft) model notification to the Director-General of the World Health Organization
WHO TRS (Technical Report Series) 1033, 2021 Annex 9:
