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close this bookUganda National Drug Policy (WHO; 2002; 45 pages)
View the documentForeword
View the documentPreface
View the documentIntroduction
View the documentMembers of the MoH Task Force on Drug Management
View the documentNational Drug Policy
View the document1. Pharmaceutical legislation and regulation
View the document2. Drug selection
close this folder3. Drug supply system (quantification, procurement, storage, distribution)
View the document3.1 Quantification
View the document3.2 Procurement (including donations)
View the document3.3 Storage and inventory control
View the document3.4 Distribution
View the document3.5 Local production
View the document3.6 Quality assurance
View the document3.7 Disposal of expired or otherwise unwanted drugs and medical supplies
Open this folder and view contents4. Rational drug use and drug information
Open this folder and view contents5. Drug financing and pricing
View the document6. Traditional medicines
View the document7. Human resource development
View the document8. Research and development
View the document9. Technical co-operation
View the document10. Monitoring and evaluation
 

3.6 Quality assurance

Goal: to protect the health of the consumer from harmful effects which may be caused by the use of counterfeit, unsafe, ineffective or poor quality medicines and other medical products.

Objectives:

1. To establish and maintain a comprehensive system of quality assurance which can efficiently detect problem products and ensure that the required safety, effectiveness and quality of medicines and other medical products is maintained throughout the entire medical supply system up to the point of use.

2. To promote a good understanding of the need for effective quality assurance of medicines and other medical products by all those involved in the medical supply process, including the consumer.


Strategies:

1. Establish, adequately support and maintain the effective and efficient operation of a reliable, comprehensive National Drug Quality Control Laboratory (NDQCL).

2. Establish effective working links between the NDQCL and other (local, regional, international) drug/medical supplies quality assurance agencies and promote active collaboration with them.

3. Establish close liaison and effective working procedures with other national bodies involved in import control and drug handling surveillance, eg. Customs, Police Drug Squad, in order to detect and intercept problem items, eg counterfeit or other unregistered medicines.

4. Select medicines on the basis of quality, safety, efficacy and stable dosage forms.

5. Only obtain medical supplies from suppliers with acceptable quality standards and procedures.

6. Ensure that medicines received from commercial suppliers and donors meet specified quality standards at the time of delivery and are registered for use in Uganda.

7. Ensure that medicines packaging meets contract requirements and can effectively withstand handling and storage conditions.

8. Ensure that any re-packaging and dispensing activities maintain quality.

9. Ensure that drug storage and transportation conditions are adequate to maintain quality.

10. Promptly address and resolve medicinal product quality concerns reported by health professionals and consumers.

11. Implement effective and efficient recall procedures to promptly remove from circulation defective medical products which may represent a health hazard to the consumer or user.

12. Provide adequate training in and supervision of drug quality assurance for those involved in the drug supply process at all levels.

13. Establish and maintain an effective drug information system to adequately support drug quality assurance requirements.

14. Design and institute a system of post-marketing surveillance (PMS) effectively to monitor the quality of medical products in circulation.

15. Disseminate relevant practical information on the need for and requirements of quality assurance measures to health professionals, patients and the public in order to help maintain medicinal product quality.

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