Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-018.00 Effective date: mm/dd/yyyy
Approved by:
5. The OOS investigation form must be completed within 30 working days and forwarded to
the QA department for review and approval.
Note
: Due to the nature of some biological tests, the OOS completion may take longer than 30 work-
ing days. Under these circumstances, efforts should be made to complete the investigation in a
timely manner.
6. The retest strategy and the analyst who performs the testing must be determined by the
QC laboratory manager.
7. The retest plan and number of repeat tests should be specified in advance prior to any
testing.
18.5.4.4
Qc analyst
8. The laboratory analyst must repeat the test for at least three times using fresh preparation
for each repeat from the original laboratory sample for each repeat.
9. Results must be reported in the investigation of OOS.
10. OOS repeat results: (see Form 01)
if
and
then
Any repeat test value is OOS
No assignable cause is
identified
The batch fails the test
An assignable cause is
identified
Follow corrective actions for
assignable cause section
Each and every repeat test value is
within the specification
The batch passes the test
Report the average of all repeat test
values as the final result
18.5.5
f
final
r
eview
, c
orrective
a
ctionS
,
and
c
oncluSionS
: (S
ee
f
orm
01)
18.5.5.1
Qc supervisor
The lab supervisor must summarize all repeat test results in the “retest reporting” section of the
OOS form and attach copies of any supporting information or data summaries to the OOS report.
18.5.5.2
Qc manager
1. The QC laboratory manager must provide the laboratory's conclusion to the OOS result in
the report.
if the batch
then
Passes the test
The QC manager should check “analytical property meets specification.”
Fails the test and a disposition decision is
required (including stability testing
failures when the product has not expired)
The QC manager should check “analytical property does not meet
specification.”
The QC manager should ensure the quality assurance is notified.
The QC manager should provide a brief summary of the conclusion of the
investigation.
Fails the tests and samples are within their
shelf lives (for stability samples only)
The QC manager should inform the QA.
The QC manager should inform registration and export director
immediately for the determination of the appropriate reporting of the OOS
test results on the product in the market.
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