Oos investigation powerpoint
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Transcript of Oos investigation powerpoint
B.Sc. Chemistry/Entomology, ACSM-CPT, Competitive Bodybuilder
OOS OOT
Comparison of results vs. a predetermined specs criteria.
Comparison of many historical data values vs. time.
e.g.: specs limit for assay 98.0-105.0%w/w of LC.Result: a particular batch has 97.2% w/w.
e.g.: same one.
Result: 98.8% w/w, although the results are within the specs, analyst should compare results w/z previous batch trend. If the average value of the trend as 99% w/w, then the batch 98.8% is OOT.
OOS
No
Release
Yes
Calculations ok?
No
Correction of calculation
Yes Analysis ok?
No
Retest n=3
Yes
Testing Protocol
Retest n≥3 ResampleFurther Investigation
Investigation Concluded
Yes
Analytical error
Sample errorProduct failure
Unknown failure
Investigation report
CAPA
No
Go to testing protocol
Lab Analysis
Satisfactory OOS results
Phase I Investigation
Phase II Investigation
Concluding the
investigation
Review Production
Additional lab testing
Reporting testing results
Averaging Outlier test
No obvious error
revealed
OOS observed during the analysis of:
Stability study Finished API
Intermediates Excipients
Raw material In-Process
Packaging material
OOS is due to
Lab error
Method analysisNon calibrated
instruments
Calculation error Analyst error
Instrument failure
Process related
Quality of raw material
Ambient environment
In-process control during manufacturing
Deviation from validated procedure
Sample homogeneity
Sampling errorPooling of
sample
Handling of sample
OOS causes
OOS investigation CDER/FDA
Phase-I investigation (Lab investigation) Phase-II investigation (Manufacturing)
Analyst observed OOS result.
Verify calculations, if the results are the same. QC supervisor shall be informed.
Log OOS.
Start Phase-I.
Review documents, instruments, RS, reagents.
Ambient Temp., storage conditions.
If there’s no abnormality observed, then report results as valid OOS and report to QA officer.
Repeat the analysis n=3 if the QA officer permits, with different analyst.
If results complies, then invalidate OOS and release batch. If not report to QA and continue OOS investigation.
Begins if an error assignable to the testing lab can’t be identified in phase-I.
Recommended by QA.
Production personnel should investigate raw material.
Process parameters.
Calibration and PM of equipment.
Contamination investigation.
Ambient environment check.
If there is no assignable cause observed, then report to QA.
QA, QC and production will evaluate the situation. The QA may request resampling.
QC shall analyze the sample as per SOP. Report results (pass/fail).
Define CAPA & release batch
Reject batch & transfer to R&D
Pass
Fail
Responsibilities
Analyst Supervisor
Verify paperwork is in order & matches label info.
Verify proper test method is used.
Retain original test prep until data and results have been checked.
Discontinue testing and notify supervisor if a problem is suspected.
Ensure each analyst is properly trained.
Ensure proper sample management within the lab.
Notify the QAU when an OOS result arises.
Ensure documentation and implementationof the retesting protocol.
Ensure investigation is conducted within the specified timeframes.
http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070287.pdf
http://images.alfresco.advanstar.com/alfresco_images/pharma/2014/08/22/c1ccdea4-5bc5-4960-9617-7ce7a7d9943e/article-6989.pdf