E-drug: Quality control of essential drugs (cont)
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Dear Nora
According to most guidelines on Good Manufacturing Practices (GMP)
including those of the WHO, a pharmaceutical manufacturer must have
a QC laboratory to test each batch produced according to approved
specifications and tes methods. If in your country the industry has
well equipped laboratories, the industry itself should be responsible
for the QC testing under the supervision of MOH through inspections.
In addition the MOH may do random sampling and testing as it finds
necessary.
It is important for the inspectorate of the MOH to establish a good
relationship with the industry and to recognize its role as adviser (not
only enforcement agency).
In most countries it is not realistic to let the MOH do the QC testing for
the industry because of limited capacity. It could also be an excuse for
the industry not to develop their QC activities according to GMP.
Best regards from Truls
Truls Eriksen
248/170, "Lotus Grove", Hill Street,
Dehiwala
Sri Lanka
Tel/Fax: (94) 1 736746
E-mail: sudathth@sltnet.lk
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