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​ DRUG QUALITY CONTROL SECTION

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Roles and Functions:

The Drug Quality Control Section is made up of three units each with different functions that are closely interrelated. The three units are as follows:-

Product Assessment Unit

This unit ensures compliance of pharmaceutical products supplied to the Ministry of Health either on tender or quotation to official standards and specifications. The core activity undertaken includes evaluation of pharmaceutical products using assessment criteria that are administrative based and quality oriented.

Compliance and Surveillance Unit

This unit undertakes activities that relate to ensuring premises dealing with pharmaceutical products comply with Good Manufacturing Practice requirements encompassing technical parameters of Good Distribution Practice (GDP) and Good Storage Practice (GSP). One core activity is the inspection of premises that include outlets that require Poisons Licence in order to operate, drug storage areas both in the private and public sectors, pharmacies and wholesalers.

The unit also undertake activities related to Product Quality Surveillance Programme. The mechanisms employed include handling of product complaints from end-users and facilitating product recalls conducted at the public sector.

Laboratory Unit

This unit conducts laboratory testing of pharmaceuticals to ensure conformance of product to official compendial specifications as part of the product quality surveillance programme. The core activities undertaken include:

? Laboratory analysis of pharmaceutical and cosmetic products.

? Facilitate analysis of traditional medicines and health supplements at testing facilities outside the unit.

Quality standards of the laboratory are maintained through regular calibration and performance checks conducted on its equipment. It gauges its performance standards against laboratories in benchmarked countries through participation in a number of proficiency testing programmes organised by the recognised bodies such as the EMEA.