Guidance on good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions

Background:

In recent years both formal and informal collaboration among national regulatory authorities (NRAs) has significantly improved. This, in turn, has strengthened medicines regulatory systems, thereby improving the availability of good quality, safe and effective medical products for patients. A number of regional and supraregional groupings of NRAs are developing, which will facilitate collaboration.

During a World Health Organization (WHO) training symposium on the subject of collaborative registration procedures for national medicines regulatory authorities held in Kenya in September 2016, delegates recommended that the gap in common guidance on best practice for performing desk assessment should be filled. It was proposed that WHO, in collaboration with regulators from Member States, develop guidance that NRAs might leverage in their national regulatory practice and decision-making.

Up to now, there has been no general guidance on approaches and best practices for desk assessment. Desk assessments are conducted in order to verify and confirm compliance with good manufacturing practices (GMP), good laboratory practices (GLP) and good clinical practices (GCP) of foreign facilities for manufacture of finished pharmaceutical products (FPPs) and active pharmaceutical ingredients (APIs), quality control laboratories (QCLs), contract research organizations (CROs) and clinical trial sites.

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Table of Contents

Background

1. Introduction

2. Aim and objectives of the guidance

3. Scope of the guidance

4. Glossary

5. Essential elements of desk assessment

5.1 High-level support and cooperation

5.2 Commonality of quality management systems in inspectorates

5.3 Convergent standards of good practices

5.4 Reliability and accuracy of information