WHO TRS 996, 2016 Annex 7

WHO TRS (Technical Report Series) 996, 2016 Annex 7

Guidelines on the conduct of surveys of the quality of medicines - Annex 7

Click on the titles below for complete guidelines

TABLE OF CONTENTS

1. Introduction 

2. Glossary 

3. Objectives of the survey and initial planning 

4. Survey management and time frame 

5. Methodology 

5.1 Selection of areas to be sampled 

5.2 Selection of medicines to be surveyed 

5.3 Selection of sample collection sites 

5.3.1 Types of sample collection sites 

5.3.2 Sampling designs 

5.3.2.1 Convenience sampling 

5.3.2.2 Simple random sampling 

5.3.2.3 Stratified random sampling 

5.3.2.4 Lot quality assurance sampling 

5.3.2.5 Sentinel site monitoring

5.4 Sampling plans 

5.4.1 Number of dosage units to be collected 

5.5 Sample collection 

5.5.1 Overt sampling versus mystery-shopper approach 

5.5.2 Instructions to sample collectors 

5.6 Storage and transportation of samples 

5.7 Testing 

5.7.1 Testing laboratory 

5.7.2 Tests to be conducted 

5.7.3 Test methods and specifications 

5.7.4 Receipt and testing of samples by a testing laboratory 

6. Data management and publication 

References

Appendix 1  Example of a sample collection form 

Appendix 2  Content of the analytical test report/certificate of analysis

Appendix 3  Outline of the content of a survey report 

1. Introduction:

Good quality medicines are essential for efficient disease management. To ensure that good quality medicines are available to patients in their countries, national medicines regulatory authorities (NMRAs) can apply various regulatory instruments.

WHO TRS (Technical Report Series) 996, 2016 Annex 7: