WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Close this folderAnnex 6. Guidelines for inspection of drug distribution channels
View the documentIntroductory note
View the documentGeneral considerations
View the documentGlossary
Open this folder and view contents1. Drug inspectors
Open this folder and view contents2. Inspection of establishments in the drug distribution chain
View the documentReferences
View the documentSelected further reading
View the documentAppendix 1. Checklist for inspection and the preparation of a report
View the documentAppendix 2. Guidance on sampling
View the documentAppendix 3. Guidance for inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard
View the documentAppendix 4. Sample receipt form
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

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.

 

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