Procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products

1. Introduction:

A significant part of the quality of a finished pharmaceutical product (FPP) is dependent on the quality of the active pharmaceutical ingredients (APIs) used for its production. Under the World Health Organization (WHO) guidelines on good manufacturing practices (GMP), it is the manufacturer of the FPP who is responsible for the overall quality of the product, i.e. including the choice of the suppliers and manufacturers of the ingredients.

However, in the context of globalization, APIs are sourced in a worldwide market and the risk of sourcing substandard or contaminated products is high. A proper system of qualification of suppliers can promote the constant sourcing of active ingredients of appropriate quality and thereby safeguard public health interests.

Full evaluation of suppliers of APIs, however, is a cost-intensive and resource-demanding activity, which only a few national medicines regulatory authorities (NMRAs) can afford. As a result, API assessment is not often part of granting marketing authorizations to FPPs, a situation which can undermine the quality and safety of marketed pharmaceutical products.

The need for quality assurance of APIs was noted in the resolutions of the 12th International Conference of Drug Regulatory Authorities in 2006. If adopted and implemented, this procedure would assist procurement agencies in validating the quality of the pharmaceutical products they are purchasing and facilitate product evaluation by NMRAs of WHO Member States as part of the marketing authorization procedures.

The purpose of this procedure is to provide relevant United Nations agencies and relevant authorities of WHO Member States, such as NMRAs, with advice on the acceptability, in principle, of APIs which are found to meet WHO-recommended quality standards.

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Table of Contents

1. Introduction

2. Glossary

3. Purpose and principles

4. Steps of the procedure

5. Invitation for expression of interest

6. Data and information to be submitted

7. Screening of dossiers submitted

8. Assessment of API dossiers

9. Site inspection

10. Reporting and communication of results of the evaluation