INTERACTIVE CONSULTING ASSOCIATES

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 GMPThe auditors need to fulfil three requirements: 1. qualification in the field they conduct the audit (production or quality control); 2. qualification in audit technique (at least 20 audit days); 3. no conflict of interest. We document the fulfilment of these requirements by delivering the CVs of the auditors and a declaration for their independence. Our principal associate Dr. Norman C. Franklin and the one who was the lead auditor for the BASF plants was member of the International Expert Working Group who wrote ICH Q7. He was awarded by the USFDA for his contribution to ICH Q7. He is the one who elaborated the audit checklist and the format of our audit reportThe purchase of an audit report includes the CVs of the auditors, a declaration of each of the two auditors for their independence, and the updates on the actions taken by the API manufacturer during three years. The audit report is valid during three years (if not indicated differently). We dont sell audit reports to a company without giving you the information first. Your company has the right to refuse that we sell the audit report to a certain company. I would be very glad if we can discuss our concept with you. It might be of interest also for your company as you are an important API manufacturer.Nitin (Indian Representative) 9221444889,