- helen @itamqmr.com
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The regulations stipulate that it should not exceed 3 years.
Generally the interval between inspections by trusted authorities should not exceed 3 years as lack of continuity may give rise to lower awareness of current GMP or allow significant deficiencies to develop —— 《A model for risk based planning for inspections of pharmaceutical manufacturers》
Considering as time zero the application of the GMP audit, the audit will be planned within one month, maximum 3 weeks for the audit report, 1-3 weeks for response to the audit observations (if any), within one week from the receipt of the response the declaration will be issued. Reasonably in 2-3 months the procedure will be closed.
Batches for clinical trials are not required to be tested in Europe. The QP will review the testing results from Chinese Laboratories.
Italy: Via A. Manzoni 13, 22070 Carbonate (CO), Italy
China — Jiangsu: Wuxi City, Jiangsu Province
China — Zhejiang: Jinhua, Zhejiang Province
Email: helen@itamqmr.com
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