Joseph KWONG Tai-wing raises an interesting question, but I wonder if it is
the question that he is realy trying to answer. Valerio Reggi has put
together an excellent reply and in this is included the question that we
are trying to answer.
The issue at hand is related to the quality of the product that is being
examined. Not just the quality of the manufacturing process but the
quality of the product as it reaches the consumer.
The Country of Origin details are surrogate answers to this question and
relate to how any country in this case country C can short cut this
assurance of the quality of the medicine. Can they accept the quality
assurance of country B or A and is it appropriate to do so. The answer is
surely dependant on the country, the circumstances of the delivery, and the
legislation pertaining in country C.
This assurance of quality of the product rests with the country receiving
the goods. They may set up systems of certification, etc with regular
inspection against GMP, and legislation wich defines responsibility and
liability,etc, but these systems are a mechanism by which they
(governments) discharge that responsibility.
Valerio Reggi is correct there is nothing wrong with examining all the
stages of manufacture and, if there is any doubt at all, it is prudent to
do so. But let us not get hung up on 'Country of Origin' when the real
issue is quality of product.
Tim Dodd
Director of Pharmacy
Shaukat Khanum Memorial Cancer Hospital
Lahore, Pakistan
["The real issue is the quality of the product" Yes but I doubt if we
should be advocating quality testing as the only method of assuring
quality! Quality assurance depends on confidence in every step of the drug
supply process and this requires confidence in the regulators in each
country . R.L. Co-Moderator]
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