-
Shipping Study SOP
1
Purpose
The
purpose of this procedure is to provide guidance
and identify the requirements on applicable
standards for shipping study on all XXX
products.
2
Scope
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.
3
Reference
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
4
Responsibilities
4.1
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 XXX
’s
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
XXX
’s
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 study
5.2
Kit Box
5.3
5.4
5.5
5.6
Carton
Data
Logger
QC standard (if
applicable)
XXX Color Card
(for Lateral Flow products)
6
Procedure
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.
Following table illustrates the time
points when the stability tests will be performed.
Temperature
3FT/25
℃
2 Days @ 55
℃
/25
℃
X
X
Days
0*
7
14
21
28
35
42
56
77
84
X
X
X
X
3
Months
4
5
6
X**
X**
* 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).