(1999; 168 pages) [Spanish]
Appendix 3. Guidance for inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard
This section addresses specifically the situation in which the inspector suspects counterfeit, spurious or substandard pharmaceutical products to be present during an inspection. This may be during either a regular inspection or an investigation aimed at detecting such products.
1. Broad objective
The presence of counterfeit, substandard and spurious pharmaceutical products in the drug distribution channels may present a danger to public health, and it is imperative that suspect products are effectively and rapidly taken out of the distribution channels and quarantined. In order to facilitate the work of the inspector, the help of capable and experienced persons involved in the distribution of products should be obtained on a proactive basis to help identify such products.
2. Standard operating procedures
(a) A written SOP for inspectors should be drawn up and made available to them.
This SOP should include at least the following information:
(i) how the suspect product should be isolated to prevent its further distribution
(ii) the size of the samples required for testing purposes
(iii) the manner in which the samples should be taken
(iv) the record-keeping procedure to be followed in recording the details of the action taken
(v) the details which should be recorded on the receipt issued for the embargoed product and/or samples taken
(vi) the type of materials which should be used for sealing samples or for embargoing or confiscating suspect products
(vii) the names, addresses and telephone numbers of persons who should be contacted to report on the action taken
(viii) special precautions to be noted by the person initiating the sampling or seizure procedure, with particular reference to correct legal procedures to be followed
(ix) where appropriate, the manner in which the suspect product should be destroyed.
(b) Where other persons are involved in the detection of counterfeit pharmaceutical products they shall operate on the basis of a suitable SOP. In any case of suspicion of counterfeit pharmaceutical products an inspector shall be notified immediately.
3. Counterfeit products
The following applies specifically to counterfeit products:
(a) When examining a possible counterfeit pharmaceutical product the inspector shall first screen the product by looking, smelling, touching and listening to the sound of the 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.
(b) 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.
(c) 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.
(d) 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.