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What Is Out of Specification (00s) : Quality Unit Should Have Wel Define SOP For 00s

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Manivasakam P
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6 views

What Is Out of Specification (00s) : Quality Unit Should Have Wel Define SOP For 00s

Uploaded by

Manivasakam P
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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What is Out of Specification (00s)

The result obtained out of defined test limit is called


out of specification.

USFDA guideline "Investigating Out of Specification


(00S) Test Results for Pharmaceutical Industry"
Published by CDER in Oct 2006.
Quality unit should have wel define SOP for 00s
The scope of SOP should be well define
History of O0S guideline
Event Year

USFDA audited Barr Laboratory, identified attempt of "Test 1989/1991/


untilpass " and other abnormality, 1992

FDA prosecuted Barr Laboratory, Court directed to FDA to Feb 1993


draft the 00S guidelines

FDAgenerated draft O0S guideline Sept 1998

FDA published final O0S guideline Oct 2006


O0s Investigation
Laboratory Investigation
Must be
Thorough
Timely
Unbiased
Well documented
Scientifically sound
O0SInvestigation -(Phase I)
Laboratory Investigation
Check list to identify obvio,us 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...
O0S 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
O0S.

Suggest the Corrective and Preventive actions e.g. training


to the Analyst, Requalification of Analyst etc. whatever the
scientifically appropriate.
o0sInvestigation -(Phase II)
Extended Investigation
If No assignable cause fou.nd 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)
Toolfor O0S Investigation & Related
Corrective and Preventive action

Identify the Suspect


5M -Tool to Identify the Route cause
Man
Machine
Material
Method

Movement
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

OTo check the reason scientifically sound - Process each


reason with six sigma technique -DMAIC
Process the Root cause

Six sigma technique (DMAIC)


Define
Measure
Analyze
Improve
Control
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

Conclude the activity in timely manner.

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