WHO TRS 1010, 2018 Annex 5

WHO TRS (Technical Report Series) 1010, 2018 Annex 5

WHO Guidance On Testing Of “Suspect” Falsified Medicines

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TABLE OF CONTENTS

1. Introduction 

1.1 “Suspect” medicines 

1.2 Responsibility of regulatory authorities 

1.3 The role of the World Health Organization 

2. Scope 

3. Glossary 

4. Detection of suspect falsified products 

4.1 Entry points for detection 

4.2 Detection methods 

4.3 Selection of analytical techniques 

5. Sampling and documentation 

5.1 Sampling 

5.2 Documentation of information on suspect falsified medical products 

5.3 Chain of custody considerations 

6. Regulatory actions upon detection of suspect falsified medical products 

6.1 Risk assessment

6.2 Questions to be answered by analytical testing 

6.3 Communication

 

7. Confirmatory analytical testing 

7.1 Laboratory capacity 

7.2 Standard operating procedure 

7.3 Testing plan and test procedures 

7.4 Interpretation and reporting of results 

8 Reporting and regulatory action on confirmed falsified medical products 

9. Archiving of samples and reports 

References 

Appendix 1: Examples of analytical techniques that may be used for package identification, screening and testing of suspect falsified medical products 

Appendix 2: Example of an information collection form 

Appendix 3: Example of the content of a standard operating procedure for testing suspect falsified tablets 

Appendix 4: Examples of flowcharts for testing of suspect falsified medicines

WHO TRS (Technical Report Series) 1010, 2018 Annex 5