# \[e-drug\] Quality control of essential drugs

**URL:** <https://talk.edrugplus.org/t/e-drug-quality-control-of-essential-drugs/9244>\
**Category:** e-drug\
**Created:** [October 3, 2000, 8:19pm UTC](https://talk.edrugplus.org/t/e-drug-quality-control-of-essential-drugs/9244 "2000-10-03T20:19:57Z")\
**Posts on this page:** 1\
**Page:** 1

<div class="post-metadata">

**Author:** ![Nora\_Giron](https://avatars.discourse-cdn.com/v4/letter/n/ecb155/32.png) [@Nora\_Giron](https://talk.edrugplus.org/u/Nora_Giron)\
**Post date:** [October 3, 2000, 8:19pm UTC](https://talk.edrugplus.org/t/e-drug-quality-control-of-essential-drugs/9244/1 "2000-10-03T20:19:57Z")

</div>

E-drug: Quality control of essential drugs  
-------------------------------------------------------------------------

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  
&nbsp;&nbsp;&nbsp;manufactured products should be carried out in quality control  
&nbsp;&nbsp;&nbsp;laboratories of the national pharmaceutical industry, as required  
&nbsp;&nbsp;&nbsp;equipment is present in these industries. Analyses should be  
&nbsp;&nbsp;&nbsp;carried out by personnel of the industry under supervision of  
&nbsp;&nbsp;&nbsp;personnel of the Ministry of Health (MOH) quality control  
&nbsp;&nbsp;&nbsp;laboratory. Personnel of the MOH quality control laboratory would  
&nbsp;&nbsp;&nbsp;also be the ones to sample drugs to be analysed.

2. Another possibility would be that personnel of the MOH quality  
&nbsp;&nbsp;&nbsp;control laboratory carry out drug analyses in the laboratories of  
&nbsp;&nbsp;&nbsp;the national pharmaceutical industries, utilizing equipment and  
&nbsp;&nbsp;&nbsp;installations of the industry.

3. Other specialists do not agree with either one of the listed  
&nbsp;&nbsp;&nbsp;alternatives, as they believe that quality control should be  
&nbsp;&nbsp;&nbsp;completelyt independent. To them, using industry laboratories,  
&nbsp;&nbsp;&nbsp;equipment and personnel is by definition not independent. They  
&nbsp;&nbsp;&nbsp;feel that use of quality control laboratories might only be  
&nbsp;&nbsp;&nbsp;acceptable when they are accredited by the national drug  
&nbsp;&nbsp;&nbsp;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  
&nbsp;&nbsp;&nbsp;  
--  
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.  
Mail administrative requests to `majordomo@usa.healthnet.org'.  
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.