ICA conducts an audit at the production plant of an API manufacturer against ICH Q7 (EU GMP Part II) free of charge. ICA then sells the audit report to several Medicinal Product Manufacturers (MPM). The benefit for the API manufacturer is a reduction of the amount of customer audits. The benefit for the MPM is to get the audit report fast and with reduced costs
The audit report enables the qualified person of the MPM to decide whether the API Manufacturer complies with GMP. The audit report has to give him the details on how the API Manufacturer complies with GMP
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