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

Shipping Study SOP1 PurposeThe purpose of this procedure is to provide guidance and identify the requirements on applicable standards for shipping study on all XXX products.2 ScopeThe scope of this procedure encompasses all shipping stability related activities of XXX products in R&D, 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.3 ReferenceEN13640: 2002 Stability Testing of In Vitro Diagnostic ReagentDesign Control SOPAccelerated Stability Study SOP XXX Gold Color Card (for LF) XXXs Final QC Procedure for each product subjected to shipping study4 Responsibilities4.1 The Research and Development Department is responsible for conducting shipping study including planning and conducting the actual shipping study activities, writing and routing study reports. R&D is also responsible for updating the shipping study file and determining if a simulated or real shipping study is needed for a product. Also, The R&D is responsible for performing functional testing of simulated shipping study according to corresponding XXXs Final QC Procedure, and provides the Functional Testing Record.4.2 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.4.3 Quality Control is responsible for performing functional testing of real shipping study according to corresponding XXXs Final QC Procedure, and provides the Functional Testing Record to R&D department as part of the shipping study report.4.4 Manufacture Department is responsible for manufacturing products that require shipping study.5 Materials:5.1 Three batches of XXX Product for shipping study5.2 Kit Box5.3 Carton5.4 Data Logger5.5 QC standard (if applicable)5.6 XXX Color Card (for Lateral Flow products)6 Procedure6.1 R&D will select the shipping study protocol to use for the final product either the simulated shipping study protocol or the real shipping study protocol.6.2 Three lots of XXX Product will be manufactured and qualified for the shipping study. The prescribed number of units needed for the QC procedure will be randomly selected from these tests, and evaluated for product performance using XXXs final QC procedure. This data will be used as the control or baseline data.6.2.1 Simulated shipping study protocola. 3XFT/25: Perform 3 freeze/thaw cycles and at the last thaw, perform the QC testing.b. 2 Days 55 /25 : Place test strips in a 55 oven for 2 days and then perform the QC testing.Following table illustrates the time points when the stability tests will be performed.TemperatureDaysMonths0*7142128354256778434563FT/25 XXXX*2 Days 55 /25 XXXX* * DAY 0: Run 10 test strips each with three controls. * Continue testing every 3 months thereafter until the 39th Month.c. Humidity study:Place the pouched devices in the 30%, 60% and =80% relative humidity environments for 48 hours. After 48 hours, perform QC testing on the devices exposed under the 3 different relative humidity conditions. d. Vacuum Test:Test units from each lot of product will be randomly selected and exposed to the reduced atmospheric pressure by placing the units under vacuum to a level of approximately 500 milliTorr for 24 hours. The prescribed number of units needed for the QC procedure will be randomly selected from these reduced pressure treated units and evaluated for product performance using XXXs final QC procedure (Refer to Vacuum Testing SOP).6.2.2 Real Shipping Study Protocola. Vacuum Test:Test units from each lot of product will be randomly selected and exposed to the reduced atmospheric pressure by placing the units under vacuum to a level of approximately 500 mTorr for 24 hours. The prescribed number of units needed for the QC procedure will be randomly selected from these reduced pressure treated units and evaluated for product performance using XXXs final QC procedure (Refer to Vacuum Testing SOP).b. Shipping Study: The prescribed number of products will be placed in 2 shipping carton. Half of the boxes will be placed in the carton in an upright position and the other will be placed in an inverted position. The Data Logger with new battery and cleared all memory on old data logged, activated and placed in each shipping carton. The logger will collect temperature and humidity readings every 10 minutes. The shipping cartons will be sealed. One carton will be shipped via air cargo and the other by sea cargo to an oversea destination predetermined by R&D. The carton will be sent back to XXX from the destination upon arrival.Upon receipt of the returned cartons, QC will be responsible visually to inspect shipping box and its contains. Special emphasis will be placed on the leakage if liquid reagents were included in the shipping study. The prescribed number of test units for QC will be randomly selected with half of the of units from the upright and half from the inverted products in boxes. XXX final QC procedure for these prescribed tests will be performed. If there is no statistical difference between the intra-lot performance data of the shipping studied products and from the controls, the air shipped products and sea shipped products, then the shipping study data will support both air and sea transportation of the product to our customers.7 Data 7.1 When shipping study is co