New WHO Guideline on Testing of Counterfeit Medicines
Recommendation
17-19 September 2024
GMP Compliance and Technology for the Manufacture of Oral Solid Dosage Forms
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The World Health Organization (WHO) has published a new guideline that describes the procedure for checking supposedly counterfeit or suspect medicines.
The WHO distinguishes three types of "Suspect Medicines":
- "Out of specification" medicines
- Unregistered/unlicensed medicines
- Medicines that have been deliberately falsified.
The present guideline deals mainly with the third category. It contains technical assistance for sampling, laboratory testing of supposedly falsified medicinal products and the corresponding reporting. Examples of this can be found in the appendix of the document for
- Analysis methods for package identification
- An information collection form
- Content of a SOP for testing counterfeit tablets
- Flowcharts for the review procedure (decision tree)
Please visit the WHO website for the new WHO guidance testing of "suspect" falsified medicines.
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