QUALITY ASSURANCE SECTION.
QUALITY ASSURANCE AND COMPLIANCE DEPARTMENT
Objective
To monitor and control the safety, efficacy and conformity to National Drug Authority and NMS Quality standards of all medicines and medical supplies procured, stored and distributed
Team
There are five members of staff in this section headed by The Quality Assurance officer, Who reports to the Corporation Secretary.
There are:
Two Quality Assurance Assistants- Pharmaceuticals
One Quality Assurance Assistant-laboratory
One Quality Assurance Assistant-Cold chain Technician
Activities
1.Application for license to operate a wholesale pharmacy, and to import/export medicines. All activities involving medicines and medical supplies in the country is regulated by N.D.A and NMS ensures that they comply with the guidelines place.
2. Setting, amending and compiling Technical specifications for medicines and medical supplies to be procured stored and distributed.
Area of focus are on:
Description of the product
Applicable quality standards e.g. B.P, USP,WHO
Packaging and labeling instructions
New innovations and technologies on the market that can be adopted e.g. a product was only available in powder form but now also available in solution form.
3. Processing Verification certificates for proforma invoices for NMS, donations and third party consignments.
Application for verification certificate (VC) to import/export medicines and medical supplies is made to NDA.
4. Inspection of receipts of all incoming Medicines and medical supplies.
Checking if the items are on purchase order.
Confirmation with technical evaluation report e.g. shelf life is 75% or more except in emergency situations where by the shelf life could be less and item is taken within a short period of time, ensuring that item is the same as the sample got during the Bidding process.
Ensuring that the items are embossed.
Checking for NDA release letters. Two types of letters are usually issued against a consignment. (Goods authorization report and conditionally released letter) etc.
5. Consignments designated for mandatory analysis or queried for any reason is kept in Quarantine where the Quality Assurance officer follows up to ensure closure.
There are about two items that undergo mandatory analysis test; (Gloves, condoms and others as routine).
Conditional release of items from the port of entry is made while the items undergo testing.
Items which Pass analysis test is put in the system to be distributed and failed test is for exportation or destruction.
6. Monitoring and controlling the storage and stock management of Narcotic drugs in line with International Narcotic Control Regulations/policies and NDA guidelines.
The section keeps the items under lock and key where picking and packing is carried out under the supervision of the Quality Assurance Assistant-pharmaceuticals.
7. Responding to product complaints, conducting investigations and where necessary instituting a product recall for medicines and medical supplies that have been rejected by either N.D.A. or customer, due to; health hazard (e.g. incorrect strength, wrong label, loss of potency).
Classification of Recall according to NDA guidelines:
Class A: Risk of serious health problem or Death
Class B: Risk of temporary or minor health problems but very low risk of serious health problems
Class C: Unlikely to cause any health problems.
8. Handling of rejected / damaged and expired medicines and medical supplies.
Physical inspection of items in the store and endorsement of the write off report.
Supervision of transfer of the non viable stock to the designated storage facility and then liaising with the service provider and NDA to carry out the destruction
9. Coordinating Quality Management System activities
Total Quality Management system applies to key processes and Procedures of an organization and auditing the procedures put in place.
Coordinating activities that can lead to Ensuring compliance to ISO Standard.