E-drug: Quality assurance
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Dear E druggers,
I have been reading with interest the comment regarding counterfeit
and sub-standard drugs.
I am a pharmacist working in Government Medical Stores in Zimbabwe
and am looking for advice from anywhere else that has started a
quality assurance program.
In Zimbabwe, all drugs have to be registered by the Medicines Control
Authority, before they can be sold within the country and the
measures are stringent. To ensure that the products we receive are
the same standard as those that pass registration, we have started a
quality assurance program and one of the parts of this has been
analysing samples of products at delivery.
So far we have tested benzyl and benzathine penicillin, TB drugs,
malaria drugs and some of the mixtures that we produce ourselves at
Government Medical Stores. We have been testing stock that we
receive from both local and foreign suppliers. We have only been
doing an assay for content.
My questions are:
1. Is assay for content enough? Should we also be doing dissolution,
contamination products etc?
2. What is a good sampling technique? Sometimes the shipment will
arrive with perhaps 30 or 40 batches in the one consignment, so
to test one of every batch will be an expensive and time
consuming game. Are there any guidelines on this?
3. We are also developing a checklist for visual inspection once the
goods arrive in store. Does anyone have such a checklist which is
already in use?
Any advice on any of the above will be greatfully appreciated.
Felicity Mayfield
Senior Pharmacist
Government Medical Stores
P.O.Box ST 23
Harare, Zimbabwe
fax 263 4 621315
ph 263 4 621991/8
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