WHO TRS (Technical Report Series) 1010, 2018 Annex 5
WHO Guidance On Testing Of “Suspect” Falsified Medicines
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TABLE OF CONTENTS
1.2 Responsibility of regulatory authorities
1.3 The role of the World Health Organization
4. Detection of suspect falsified products
4.1 Entry points for detection
4.3 Selection of analytical techniques
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
6.2 Questions to be answered by analytical testing
7. Confirmatory analytical testing
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
Appendix 2: Example of an information collection form
Appendix 4: Examples of flowcharts for testing of suspect falsified medicines
WHO TRS (Technical Report Series) 1010, 2018 Annex 5