体外诊断试剂运输稳定性研究方案shipping Study Protocol.docxVIP

Shipping Study SOPPurposeThe purpose of this procedure is to provide guidance and identify the requirements on applicable standards for shipping study on all XXXproducts.ScopeThe scope of this procedure encompasses all shipping stability related activities of XXX products in RD, QC/QA and Manufacturing Departments of XXX . The shipping stability testing of in vitro diagnostic (IVD) reagents includes Lateral flow products, calibrators, control materials and kits.ReferenceEN13640: 2002Stability Testing of In Vitro Diagnostic ReagentDesign Control SOPAccelerated Stability Study SOPXXX Gold Color