E-drug: Quality control of essential drugs
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Dear E-drug friends,
In one of the Latin American countries discussions are being held on
quality control of locally manufactured drugs. The country does not
have the required capacity (infrastructure/equipment) to carry out all
needed tests, and the following three positions have been intensively
discussed:
1. Some professionals recommended that quality control of locally
manufactured products should be carried out in quality control
laboratories of the national pharmaceutical industry, as required
equipment is present in these industries. Analyses should be
carried out by personnel of the industry under supervision of
personnel of the Ministry of Health (MOH) quality control
laboratory. Personnel of the MOH quality control laboratory would
also be the ones to sample drugs to be analysed.
2. Another possibility would be that personnel of the MOH quality
control laboratory carry out drug analyses in the laboratories of
the national pharmaceutical industries, utilizing equipment and
installations of the industry.
3. Other specialists do not agree with either one of the listed
alternatives, as they believe that quality control should be
completelyt independent. To them, using industry laboratories,
equipment and personnel is by definition not independent. They
feel that use of quality control laboratories might only be
acceptable when they are accredited by the national drug
regulatory office.
I would like to present these positions to you and hear from you
whether similar discussions have been held elsewhere in the
developing world and what decisions have been made.
Nora Giron Aguilar
Consultant
Programa Nacional de Medicamentos Esenciales de Bolivia
OPS/OMS Bolivia
e-mail: ngiron@bol.ops-oms.org
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