Overview

The linked document, WHO Technical Report Series No. 1052, Annex 4: WHO good practices for pharmaceutical quality control laboratories, is consistent with the requirements of the WHO good manufacturing practices for pharmaceutical products (1) and international standard ISO/IEC 17025:2017 (2), providing detailed guidance for laboratories performing quality control testing of medicines.

The document provides advice on the quality management system (QMS) within which the analysis of pharmaceutical products by Quality Control Laboratories should be performed to ensure that accurate and reliable results are obtained. Compliance with the recommendations provided in these guidelines will help promote international harmonization of good practices for pharmaceutical QCLs and facilitate mutual recognition of test results.

Link to Document

TRS 1052 - ANNEX 4: WHO GOOD PRACTICES FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES