Guidelines on the conduct of surveys of the quality of medicines - Annex 7
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TABLE OF CONTENTS
3. Objectives of the survey and initial planning
4. Survey management and time frame
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
5.3.2.2 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
5.4.1 Number of dosage units to be collected
5.5.1 Overt sampling versus mystery-shopper approach
5.5.2 Instructions to sample collectors
5.6 Storage and transportation of samples
5.7.3 Test methods and specifications
5.7.4 Receipt and testing of samples by a testing laboratory
6. Data management and publication
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.
Guidelines on the conduct of surveys of the quality of medicines - Annex 7: