RE: API GMP Re-Inspections Contribution from JD Mallet written on 1/24/2012 at 22:14
Original contribution: API GMP Re-Inspections written by Senthil Kumar on 1/24/2012 at 16:37) Dear Senthil,
As you wrote it routine API EU-GMP inbspections are not mandatory.
However routine audits are requested by the EU competent authorities. In other words, the finsiehd product manufacturer has to arrange for routine GMP audits (every 3 year if not otherwise justified).
Normally this should be satisfying to an EU authority (I mean if the QP declaration guarantees that the API manufacturing site has been recently audited against EU-GMP).
Answering this Contribution:
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