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Out of Specification

This document discusses guidelines for handling out-of-specification (OOS) test results according to USFDA regulations. It provides a brief history of OOS guidelines, noting that the current 2006 guidelines were published after FDA investigations found attempts to falsify test results. Any OOS result requires a thorough, timely, and documented investigation by the quality unit to identify the root cause, whether it be laboratory error, issues with materials or equipment, or problems elsewhere in the manufacturing process. A five-step process using tools like 5M analysis, the 5 why technique, and Six Sigma DMAIC is recommended to fully investigate the root cause and implement corrective and preventive actions.

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Bhupendra Tomar
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Download as PPTX, PDF, TXT or read online on Scribd
411 views

Out of Specification

This document discusses guidelines for handling out-of-specification (OOS) test results according to USFDA regulations. It provides a brief history of OOS guidelines, noting that the current 2006 guidelines were published after FDA investigations found attempts to falsify test results. Any OOS result requires a thorough, timely, and documented investigation by the quality unit to identify the root cause, whether it be laboratory error, issues with materials or equipment, or problems elsewhere in the manufacturing process. A five-step process using tools like 5M analysis, the 5 why technique, and Six Sigma DMAIC is recommended to fully investigate the root cause and implement corrective and preventive actions.

Uploaded by

Bhupendra Tomar
Copyright
© © All Rights Reserved
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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Handling OOS

(Out of Specification)

Dr Ravi Kinhikar

What is Out of Specification (OOS)


The result obtained out of defined test limit is called
out of specification.
USFDA guideline Investigating Out of Specification
(OOS) Test Results for Pharmaceutical Industry
Published by CDER in Oct 2006.
Quality unit should have well define SOP for OOS
The scope of SOP should be well define
Dr Ravi Kinhikar - General Manager -QC

History Of OOS guideline


Event

Year

USFDA audited Barr Laboratory, identified attempt


1989/1991/
of Test until pass and other abnormality,
1992
Resulted in 483
FDA prosecuted Barr Laboratory, Court directed to
FDA to draft the OOS guidelines

Feb 1993

FDA generated draft OOS guideline

Sept 1998

FDA published final OOS guideline

Oct 2006

Dr Ravi Kinhikar - General Manager -QC

OOS Investigation
Laboratory Investigation
.

Must be

Thorough

Timely

Unbiased

Well documented

Scientifically sound

Dr Ravi Kinhikar - General Manager -QC

OOS Investigation (Phase I)


Laboratory Investigation
Check list to identify obvious
. Laboratory error
1. Analyst qualification and training on intended work
2. Correctness Test specification and Method
3. Instrument calibration or performance
4. Preparation test solutions and dilutions
5. Validity of Reagents and standards
6. Performance of system suitability
7. Correctness of calculation and etc.

Dr Ravi Kinhikar - General


Manager -QC

OOS Investigation (Phase I)


Laboratory Investigation
If Analyst Error identified,.it should be
logical and appropriate
not on hypothetical basis
Identify appropriate assignable cause for Laboratory error
Correct the error, and repeat the analysis to invalidate the
OOS.
Suggest the Corrective and Preventive actions e.g. training
to the Analyst, Requalification of Analyst etc. whatever the
scientifically appropriate.
Dr Ravi Kinhikar - General Manager -QC

OOS Investigation (Phase II)


Extended Investigation
If No assignable cause found
. in phase I investigation,
Phase II investigation should be initiated
Retesting of Material with other analyst (n 3)
Resampling and testing
Investigation at Plant
Further Extend investigation (upon rejection)

Dr Ravi Kinhikar - General Manager -QC

Tool for OOS Investigation &


Related Corrective and
Preventive action

Dr Ravi Kinhikar

Identify the Suspect


5M Tool to Identify the Route cause
Man
Machine
Material
Method
Movement
Dr Ravi Kinhikar - General Manager -QC

Scan the Suspect

Target the suspect

Use 5 why technique to reach at root cause

Ask Why, Why, Why, Why and Why five times and try to
reach at more probable reason

To check the reason scientifically sound - Process each


reason with six sigma technique -DMAIC

Dr Ravi Kinhikar - General Manager -QC

Process the Root cause


Six sigma technique (DMAIC)
Define
Measure
Analyze
Improve
Control

Dr Ravi Kinhikar - General Manager -QC

Corrective And Preventive Action

Draw appropriate root cause.

Root cause should be logical and scientific.

Collect the historical evidence if any with same process or any


other process in the plant.

Identify the need for extend the investigation to past or future


batches

Provide corrective action with evidence

Suggest preventive action


( corrective action should be reviewed against similar process in
the plant for no impact)
Conclude

the activity in timely manner.

Dr Ravi Kinhikar - General Manager -QC

Admire your Questions


Thanks!!!

Dr Ravi Kinhikar - General Manager -QC

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