The following applies specifically to counterfeit products:
- When examining a possible counterfeit pharmaceutical product the inspector shall first screen the product by looking, smelling, touching and listening to the sound of me packing and its contents. The inspector shall look for anything, in particular its labelling and packing, that makes the product look different from an original reference sample. A SOP may assist in examining the product in this way.
- When the organoleptic examination does not give conclusive evidence the inspector shall have a sample tested using appropriate simple screening methods, such as the basic tests recommended by WHO or a suitable thin-layer chromatography method.
- In addition to any full analytical testing, the drug regulatory authority of the country of origin stated on the label of the product may be asked to establish whether the product is counterfeit.
- Proven cases of counterfeit pharmaceutical products shall be fully documented and communicated to all other inspectors, to increase their level of expertise. Information on counterfeit products shall also immediately be made available to drug regulatory authorities of other countries concerned and to WHO.