Counterfeit Drugs: 8. Inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard

Counterfeit Drugs
(1999; 61 pages) [French] [Spanish]

Table of Contents

	Executive Summary
	1. Introduction
		1.1 Background
		1.2 DMP-DAP joint project on counterfeit drugs
		1.3 Structure of the guidelines
	2. Overview of the problem
	3. Impact on public health
	4. Factors facilitating counterfeiting
	5. Developing national strategies
		5.1 General considerations
		5.2 Plan of action
		5.3 Monitoring and evaluation
	6. Specific measures
		6.1 Strengthening political will and commitment
		6.2 Promulgating appropriate legislation
		6.3 Establishing a national drug regulatory authority
		6.4 Developing standard operating procedures and guidelines for drug inspectors
		6.5 Enforcing drug control laws
		6.6 Empowering the judiciary
		6.7 Fostering partnerships
		6.8 Sharing responsibilities
	7. Assessment of the problem at the national level
		7.1 Approaches
		7.2 Sampling procedures
		7.3 Limitations
	8. Inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard
		8.1 Broad objective
		8.2 Standard operating procedures (SOP)
		8.3 Counterfeit products
	9. Test methods
		9.1 Methods based on thin-layer chromatography
		9.2 Other simple methods
		9.3 Analytical techniques
		9.4 Visual inspection
		9.5 Successful implementation of simple tests
	10. Developing training programmes: inspection and examination of counterfeit pharmaceuticals
		10.1 General remarks
		10.2 Training programme on inspection
		10.3 Training programme on examination
		10.4 The practical issues of organizing and implementing the programme (35)
	11. Conclusion
	References
	Selected further reading
	Acknowledgements
	Glossary

8. Inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard

The following guidance was approved by the Thirty-fifth Expert Committee on Specifications for Pharmaceutical Preparations and is reproduced from the Expert Committee's report (24). It addresses specifically the situation in which an 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.