E-drug: Quality assurance (cont'd)
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With regard to quality assurance sampling I have been very impressed
with the advice I heard given by Dr Enrique Fefer the PAHO essential
drugs adviser and the practices I saw undertaken at IDA.
Dr Fefer suggested that if Thin layer chromatography was conducted
for quality of the content and dissolution testing used for assessing
formulation, only a small proportion of drugs would need to be sent
for HPLC assay.
At IDA I saw a system in which new suppliers were actively tested.
For every consignment a number of samples were taken and tested.
After 3-5 consignments had passed the rate of testing reduced to
random samples from each consignment. I was also impressed that
IDA kept samples of every consignment for five years (I think) so that
if there was any question about quality they would have samples
available that they could retest to see if there were any problems.
I think the question Felicity Mayfield asked about an initial quality
checklist is an interesting one. I have not seen an ideal example. In
MDS2 on page 346 we have a Checklist that could be used as the
basis for such a form.
I think that the most important reason to do something about quality
assurance on receipt in the store is that if the suppliers know that you
have a system in place to check they are more likely to try to ensure
consistent quality.
I would be interested in hearing more details about the results of the
activities in Eritrea. What drugs failed dissolution? Were the suppliers
new suppliers or old ones? Did they have QC certificates available?
Richard Laing Tel 617 414-1444
Associate Professor Fax 617 638-4476
Department of International Health E-mail richardl@bu.edu
Boston University School of Public Health
715 Albany St, Boston MA 02118-2526, USA
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