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
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
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
Close this folderAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
Close this folder1. General remarks
View the document1.1 Introduction
View the document1.2 Requirements and goals of the training programmes for inspection and examination
View the document1.3 Prerequisites
Open this folder and view contents2. Training programme for inspection
Open this folder and view contents3. Training programme on examination
View the documentReferences
View the documentWorld Health Assembly resolutions
View the documentAppendix 1 The practical issues of organizing and implementing the programme
View the documentAppendix 2 Thin-layer chromatography and its application
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

1.1 Introduction

Counterfeit pharmaceuticals may be a serious risk to public health. It is the responsibility of governments to ensure that counterfeit pharmaceuticals are taken off the market and their sources found and eradicated. This should be a part of an overall quality control system. Clearly, expertise in drug inspection and drug examination is required. These guidelines are intended to be used to train relevant staff.

The detection and prosecution of criminals who market counterfeit pharmaceuticals have several stages. First of all, suspect products have to be traced. The drug, sampled according to an established procedure, should undergo defined physical or organoleptic examination by the drug inspector. If the results indicate that the drug formulation may be a counterfeit product, then at least some chemical tests must be repeated to confirm the necessity for further analysis. Drugs are then analysed by simple tests, including thin-layer chromatography. If these tests do not provide conclusive evidence and the drug is still considered to be a possible counterfeit, then a compendial procedure is required.

Throughout the investigation, it is assumed that a chain of custody has been established, i.e. the correct procedures were followed before the drug was received for analysis by the laboratory. This ensures that the results of these examinations are reliable and will be accepted as valid in future steps, e.g. prosecution of the supplier of the counterfeit pharmaceuticals. The final results shall be submitted to the appropriate official in the drug regulatory authority.

Section 2 describes the training necessary for inspectors. Section 3 describes training in the design and implementation of a specific programme for the screening of counterfeit pharmaceuticals. There are several common requirements for both inspection and chemical testing, and these are included as items in the training programmes for inspection and examination of counterfeit pharmaceuticals. It is assumed that the trainers are already suitably experienced to perform the required inspection, examination and training. The two-tiered approach of the training programme should include training of trainers, who in turn educate those who need to be trained in drug inspection and examination. The main focus of these guidelines, however, is the training of the trainees.

The practical issues to be considered in the organization and implementation of the programme are described in Appendix 1.

Each country must develop its own strategy, appropriate for its situation, the availability of an institutional framework, and its professional and economical resources. Ideally it should be prepared by the country's drug regulatory authority in consultation with all major parties involved in the manufacturing, importation, distribution, sale, prescribing and use of legitimate drugs.

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