Drug quality control
Your staff correspondent's eye opening report on the matter published on 19 November, particularly the response from the manufacturer, clearly reflects the relaxed attitude to Quality Control of the manufacturer!
Firstly, the respondent was not sure, if it was their product, based on the fact that he had not seen the offending ampoule. Yet without seeing, he confidently states " It will not (and not "may not" since he is so sure!) pass through the syringe needle, and there is no possibility of its entering the vein of the patient". All this was stated, without knowing the cross-sectional area of the bore of the needle used, or the size of the particle! Yet he is positively confident, that nothing wrong can happen to the patient, in using the contaminated ampoule!
On top of it he also says "no company can guarantee that there would not be a single ampoule among 15 million without defect". That is OK; so according to him, manufacturers can sell defective products! This despite the fact that he also says "If it is our product, I have to say it was a procedural mistake". Rather contradictory statements, but with no responsibility for procedural mistakes was mentioned!
According to his statements it appears that injectable contamination is just a defect only, nothing serious. Would the person kindly inform the public about the relevant ISO standards of quality control, under which contamination of injectables by foreign body, is only considered as a defect, and the product can be sold!
Any organisation, where such laxity of manufacturing quality control is allowed, should have its drug manufacturing license suspended forthwith, and further manufacture stopped.
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