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

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 Card (for LF)XXX’s Final QC Procedure for each product subjected to shipping studyResponsibilitiesThe Research and Development Department is responsible for conducting shipping study including planning and conducting the actual shipping study activities, writing and routing study reports. RD is also responsible for updating the shipping study file and determining if asimulated or real shipping study is needed for a product.Also, The RD is responsible for performing functional testing of simulated shipping study according to corresponding XXX’s Final QC Procedure, and provides the Functional Testing Record.Quality Assurance is responsible for ensuring that the shipping study is performed in accordance with this procedure. They are also responsible for maintaining the shipping study files.Quality Control is responsible for performing functional testing of real shipping study according to corresponding XXX’s Final QC Procedure, and provides the Functional Testing Record to RD department as part of the shipping study report.Manufacture Department is responsible for manufacturing products that require shipping study.Materials:Three batches of XXX Productfor shipping studyKit BoxCartonData LoggerQC standard (if applicable)XXX Color Card (for Lateral Flow products)Procedure6.1 RD will select the shipping study protocol to use for the final product – either the simulatedshipping st