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

Shipping Study SOP

1Purpose

The purpose of this procedure is to provide guidance and identify the requirements on applicable standards for shipping study on all XXX products、

2Scope

The 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、

3Reference

EN13640: 2002 Stability Testing of In Vitro Diagnostic Reagent

Design Control SOP

Accelerated Stability Study SOP

XXX Gold Color Card (for LF)

XXX’s Final QC Procedure for each product subjected to shipping study

4Responsibilities

4.1The 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 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 XXX’s Final QC Procedure, and provides the Functional Testing Record、

4.2Quality 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、

4.3Quality 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 R&D department as part of the shipping study report、

4.4Manufacture Department is responsible for manufacturing products that require shipping

study、

5Materials:

5.1Three batches of XXX Product for shipping study

5.2Kit Box

5.3Carton

5.4Data Logger

5.5QC standard (if applicable)

5.6XXX Color Card (for Lateral Flow products)

6Procedure

6、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 XXX’s final QC procedure、 This data will be used as the control or baseline data、

6、2、1 Simulated shipping study protocol

a.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、

* 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 XXX’s final QC procedure (Refer to Vacuum Testing SOP)、

6、2、2 Real Shipping Study Protocol

a.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 XXX’s 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