Out of specification (oos)1
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This document discusses guidelines for handling Out of Specification (OOS) test results in the pharmaceutical industry. It provides an overview of the history of OOS guidelines, including FDA audits in the 1980s-90s that identified issues like "testing until pass", which led the FDA to publish formal OOS guidelines in 2006. The document outlines the OOS investigation process, which should first thoroughly check for laboratory errors and assign a cause, then may proceed to extended investigations including retesting or plant investigations if no error is found. Tools like 5M analysis and the five whys technique can be used to identify and analyze the root cause.
Out of specification (oos)1
- 1. Dr Ravi Kinhikar Handling OOS (Out of Specification)
- 2. 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
- 3. History Of OOS guideline Event Year USFDA audited Barr Laboratory, identified attempt of “Test until pass “ and other abnormality, Resulted in 483 1989/1991/ 1992 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
- 4. OOS Investigation Laboratory Investigation . Must be • Thorough • Timely • Unbiased • Well documented • Scientifically sound Dr Ravi Kinhikar - General Manager -QC
- 5. 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
- 6. 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
- 7. 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
- 8. Tool for OOS Investigation & Related Corrective and Preventive action Dr Ravi Kinhikar
- 9. Identify the Suspect 5M –Tool to Identify the Route cause Man Machine Material Method Movement Dr Ravi Kinhikar - General Manager -QC
- 10. 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
- 11. Process the Root cause Six sigma technique (DMAIC) Define Measure Analyze Improve Control Dr Ravi Kinhikar - General Manager -QC
- 12. 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
- 13. Admire your Questions… Thanks!!! Dr Ravi Kinhikar - General Manager -QC