Counterfeit Drugs: 8. Inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard: 8.2 Standard operating procedures (SOP)

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

8.2 Standard operating procedures (SOP)

• A written SOP for inspectors should be drawn up and made available to them.

This SOP should include at least the following information:

- how the suspect product should be isolated to prevent its further distribution

- the size of the samples required for testing purposes

- the manner in which the samples should be taken

- the record-keeping procedure to be followed in recording the details of the action taken

- the details which should be recorded on the receipt issued for the embargoed product and/or samples taken

- the type of materials which should be used for sealing samples or for embargoing or confiscating suspect products

- the names, addresses and telephone numbers of persons who should be contacted to report on the action taken

- special precautions to be noted by the person initiating the sampling or seizure procedure, with particular reference to correct legal procedures to be followed

- where appropriate, the manner in which the suspect product should be destroyed.

• 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.