Many quality assurance processes are involved before medical products are finally delivered to the end-user. Procurement is a complex system, which does not end at the point of needs assessment and placing an order. Awareness of various aspects of procurement, such as product quality, country regulations, etc., is crucial to carrying out the task successfully.
The same need to be knowledgeable applies to manufacturers and more so to wholesalers. Medical suppliers nowadays come in a variety of shapes and sizes, and with varying levels of expertise, understanding and quality assurance capability. A supplier's competence in terms of understanding and quality assurance of the products which are offered should always be questioned rather than assumed. A competent and professional supplier will be able to give you details not only of their own quality controls on the products that they sell, but also provide you with basic documentary evidence from the manufacturer confirming that they are authorized, competent and manufacturing to certain specifications. A supplier unable to provide this basic evidence is not fulfilling a crucial element of their responsibility which is the consistent and reliable supply of quality products.
Knowledge of related policy issues is important, as economic and political matters become increasingly intertwined in health care provision. Information is needed in order to understand the issues. While arguments persist about the role of industry in public health care, it is important to understand the background to these discussions.
Further reading and sources of information:
1. World Health Organization. Guidelines for Drug Donations. WHO/EDM/PAR/99.4 (1999).
2. World Health Organization. Good Manufacturing Practices for Pharmaceutical Products. Technical Report Series, No. 823, 1992, Annex 1.
3. World Health Organization. Operational Principles for Good Pharmaceutical Procurement. WHO/EDM/PAR/99.5 (1999).
4. World Health Organization. Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. WHO/PHARM 82.4 Rev. 5.
5. Rosenberg, H. Incoterms Update. In: Overseas Trade (Trade Finance), 26-27 (2000). www.brittrade.com/dbt
6. Rowbotham, M. Considering Customs. In: Overseas Trade (Customs), 24-26. (2000).
7. Hodgetts, M. Good Cause and Effect on Strategic Buying by Charities. In: Supply Management, 24-27 (2000). (www.supplymanagement.co.uk).
8. Kennedy, D. Sweet and Sour Source (Sourcing in China). In: Supply Management, 30-31 (2000).
9. International Chamber of Commerce. International Rules for the Interpretation of Trade Terms, 1990. Available from: ICC, 14 Belgrave Square, London SW1X 8PS www.iccwbo.org
10. IFPMA Code of Pharmaceutical Marketing Practices and International Conference of Harmonisation (ICH). International Federation of Pharmaceutical Manufacturers Associations (IFPMA), 1211 Geneva 18, Switzerland. Tel: +41 (22) 340 12 00 Fax +41 (22) 340 13 80 at: firstname.lastname@example.org or: www.ifpma.org
11. CEN Management Centre, 36 rue de Stassart, B-1050 Brussels, Tel: +32 2 550 08 19; Fax: +32 2 550 08 11; at: email@example.com or: www.cenorm.be.
12. The American Society for Quality, 611 East Wisconsin Avenue, P.O. Box 3005, Milwaukee, WI 53201-3005 www.asq.org
13. ECHO International Health Services Limited, Ullswater Crescent, Coulsdon, Surrey, CR5 2HR, UK. Tel: +44 (0)20 8660 2220; Fax: +44 (0)20 8668 0751; at: firstname.lastname@example.org or: www.echohealth.org.uk.
14. Quality Systems for Pharmaceutical Inspectorates. Pharmaceutical Inspection Convention (PIC) and (PIC/S) Presentation at a seminar held in Zeist (Holland) 9-12 June 1998. Available from: European Free Trade Association (EFTA), 9-11 rue de Varembe, CH-1211 Geneva 20, Switzerland
15. Sharp, J. British Standards on Quality and the ISO 9000 Series. In: Quality in the Manufacture of Medicines and Other Healthcare Products. Pharmaceutical Press 96-104(2000)
16. Sharp, J. The Regulatory Factor. In: Quality in the Manufacture of Medicines and Other Healthcare Products. Pharmaceutical Press, 29-41 (2000).
17. One CE marking. Council Directive, 93/42/EEC, European Commission, 14 June 1993. www.eudra.org
18. Management Sciences for Health. Managing Drug Supply: Selection, Procurement, Distribution and Use of Pharmaceuticals in Primary Health Care, (1997).