- All > Medicine Information and Evidence for Policy > Information and Publications
- All > Quality and Safety: Medicines > Quality Assurance
- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Keywords > prequalification of medicines
- Keywords > Prequalification of Medicines Programme - WHO
- Keywords > prequalification of Quality Control Laboratories
- Keywords > quality assurance system
- Keywords > quality control
- Keywords > quality control laboratories (QCLs)
- Keywords > quality of medicines
- Keywords > quality standards
- Keywords > quality tests - medicines
- Keywords > supplier audits
(2010; 16 pages) [French]
EPN, its members and partners have been working for many years to increase access to essential medicines and promote their rational use. An important requirement for these objectives is the quality of medicines. As much as medicines are essential to curing or even preventing diseases, if their quality is not assured, they can become a health hazard. Medicines that do not contain the right active ingredients in the right dosage or contain harmful substances, medicines that are not manufactured, transported or stored under the right conditions, can all pose a health risk to patients.
Regulatory bodies have the ultimate responsibility for the quality of medicines in their markets. Nevertheless, pharmaceutical wholesalers, distributors and all other institutions along a medicines supply chain can and should take quality assurance into their own hands and set up mechanisms to pick out counterfeit and substandard pharmaceuticals and ensure that the medicines they provide are safe and effective. Patients as well should not stand powerless, especially in developing countries. Buying only from licensed outlets and avoiding medicines that appear to have been tampered with are some of the measures any member of the public can take. Even in resource-limited settings, steps can be taken to evaluate the quality of medicines and reduce the risk of having poor quality medicines in the supply chain. Such mechanisms include visual inspection and proper storage and handling. For a number of years, WHO has supported national and global medicines procurement by prequalifiying medicines which meet international standards (p3). For those who wish to test the medicines, the minilab provides a relatively low-cost, low-tech option. From page 6, the head of QA at JMS in Uganda reflects on the benefits and challenges of using this technology. Supplier audits require significant resources. A workshop by action medeor and EPN (p8) showed that joint audits are more cost-effective and increase the impact on the supplier. MEDS in Kenya operates a WHO prequalified quality control laboratory for physical and chemical analysis of medicines and active pharmaceutical ingredients (p11).
It is our hope that you will find useful information in this issue, whether you are producing, buying, selling or taking medicines.
In this issue:
- WHO medicines prequalification: value for money
- Using the minilab. The JMS experience
- Supplier auditing: a shared experience of quality assurance
- Quality assurance at MEDS
- Voluntary testing of quality of medicines supplied by EPN member institutions
- Quality issues in pharmaceuticals