API GMP Re-Inspections Contribution from Senthil Kumar written on 1/24/2012 at 16:37
I understand the European legislation does not require mandatory routine GMP inspections for active substance manufacturers.
Given the scenario, Concerned Inspectorate is not opting to re-audit API facility owing to resource constraints - what could be alternative strategy that an API manufactuer could adopt? Has there been any instances of simialr issues faced by the forum members?
On the other hand, I wish to know whether WHO GMP certificate will entitle a API manufacturer from a third country to EU? Will the EU accept WHO GMP certification in place of EU GMP certification?
Regards,
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