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Change control oos oot

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AMOGH DANDEKAR

This document discusses concepts of change control, out of specifications (OOS), and out of trends (OOT) in pharmaceutical quality assurance. It defines change control as a procedure to review, verify, regulate, manage, approve and control changes made to systems or processes. OOS refers to test results that fall outside pre-defined acceptance criteria, while OOT describes results that do not follow expected trends. The document outlines procedures for investigating and managing changes, OOS, and OOT to ensure product quality and compliance with regulations.

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CONCEPT OF CHANGE CONTROL, OUT OF SPECIFICATIONS (OOS) AND OUT OF TRENDS (OOT) P R E S E N T E R : MR. AMOGH P. DANDEKAR FIRST YEAR M.PHARM DEPT. OF PHARMACEUTICAL QUALITY ASSURANCE REG.NO: NH0117005 DATE: 14/11/2017 1
CONTENT  Concept of Change control  Procedure of change control  Management of change control  Conditions of change control  Out of specifications(OOS)  Out of trends(OOT) 2
CONCEPT OF CHANGE CONTROL  Change: any modification to product, document, process, equipment, instrument, system, facility etc.  Change control :procedure reviews, verifies, regulates, manages, approves and controls changes made to the existing operating system or facility or process or procedure or document or product of any combination 3
CONCEPT OF CHANGE CONTROL  The key principles of change control are :  What was done, why, when, where, by whom, how  Results, including the impact of changes to other processes. 4
MANAGEMENT OF CHANGE CONTROL Written procedures should be established and maintained to control changes for:  Processes, Facilities, Utilities  Methods, Validation, Computer systems  Training and training materials  Regulatory filings and Quality systems  Changes should be justified and documented.  All changes that have the potential to impact the quality, safety and efficacy should be evaluated, reviewed and approved 5
6 CHANGE CONTROL CYCLE
PROCEDURE OF CHANGE CONTROL 7
CONDITIONS FOR CHANGE CONTROL  Revalidation  Requalification  Increased testing  Stability analysis  Document change  Regulatory action / variation application 8
9
OUT OF SPECIFICATIONS (OOS) 10
OUT OF SPECIFICATIONS (OOS) Out of Specification (OOS) means the test result that falls outside the specifications or acceptance criteria which has been specified in the official compendia monographs or the finished product specification in registration dossiers. 11
OOS IS OBSERVED IN ANALYSIS OF:  Stability study  Finished product  In-process  Raw materials  Packing materials 12
US FDA : GUIDELINE FOR INDUSTRY INVESTIGATING OOS TESTING RESULTS FOR PHARMACEUTICAL PRODUCTION  PHASE I: LABORATORY INVESTIGATION should include an initial assessment of the accuracy of the laboratory's data.  PHASE II: FULL-SCALE OOS INVESTIGATION consist of a production process review and/or additional laboratory work 13
LABORATORY ERROR Laboratory error is the cause of OOS result which may occur from instrument, reagent, reference standard, environment condition, test method, analyst and calculation within laboratory. 14
TYPES OF LABORATORY ERRORS 15
PROCEDURE OF OOS  REPORTING TO LABORATORY SUPERVISOR  RECORDING AND NUMBERING OF OOS  INVESTIGATION BY ANALYST  LABORATORY TESTING  APPROVAL BY LAB. SUPERVISOR  TESTING BY ANALYST 16
PROCEDURE OF OOS  PREPARATION OF TEST REPORT  EVALUATION OF SUSPECT RESULTS.  INVESTIGATION BY TECHNICAL MANAGEMENT TEAM.  CONCLUSION AND REPORT OF DATA.  EVALUATION BY QUALITY MANAGER. 17
OOS INVESTIGATIONS  Re-testing:  The analysis of original sample at the time of phase- I laboratory investigation.  Re-sampling:  The original batch is sampled by QA second time after QA head authorization for re-analysis.  Re-analysis:  The analysis of re-sampled material for the verification of results, if manufacturing investigation does not have root cause. 18
19 REGULATORY IMPACT ON OOS  Stability study required  OOS should be reported to RA  OOS batch should not be sold to Regulatory market  OOS batch can not be blend with fresh approved batch  OOS batch can not be directly sell to the market
OUT OF TRENDS (OOT) 20
WHAT IS OUT OF TREND (OOT) ?  A result that does not follow the expected trend, either in comparison with other stability batches or with respect to previous results collected during a stability study.  More complicated than a comparison to specification limits. 21
CRITERIA TO CONSIDER A RESULT AS OOT !  For ASSAY: 5% Change in initial value of assay.  For IMPURITIES: Between 0.1 to 0.2 % increase or decrease as per initial reports . 22
OOT CAN BE DUE TO:-  ASSIGNABLE CAUSE : Laboratory errors  NON- ASSIGNABLE CAUSE: Non-laboratory errors. 23
METHOD FOR IDENTIFYING OOT  For the purpose of this study, data from ongoing stability studies of a final drug product with a shelf life of 36 months is used.  The ongoing studies were conducted on 10 batches of Product X. (solid dosage form)  The ongoing studies were conducted for 36 months in stability chambers at a constant temperature of 25 °C ± 2 °C and relative humidity of 60% ± 5% in accordance with the ICH guideline Q1A.  Analyst should carry out a assay at a time point of 0,3,6,9,12,18,24 and 36 months for all batches. 24
TYPES OF OOT DETERMINATION:  Regression-control-chart-method. The regression-control-chart method is used to compare the results within the batch and detect present OOT results. For the purpose of this method, the tenth batch is examined.  By-time-point method. The by-time-point method is used to determine whether a result is within expectations on the basis of experiences from other batches measured at the same stability time point. 25
OOT CYCLE 26
 WHO, Quality Assurance of Pharmaceuticals, Vol 2, Second Edition http://www.who.int/medicines/areas/quality safety/quality_assurance /production/en/  Choudhary A. What is Change Control ? . Pharmaguideline.com. 2017 . Available from: http://www.pharmaguideline.com/2010/11/what-is-change- control.html  Fda.gov. 2017 . Available from: https://www.fda.gov/downloads/drugs/guidances/ucm070287  OOS, OOT, OOC, and OOSC Pharmtech.com. 2017 Available from: http://www.pharmtech.com/oos-oot-ooc-and-oosc 27 REFERENCE:
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More Related Content

Change control oos oot

  • 1. CONCEPT OF CHANGE CONTROL, OUT OF SPECIFICATIONS (OOS) AND OUT OF TRENDS (OOT) P R E S E N T E R : MR. AMOGH P. DANDEKAR FIRST YEAR M.PHARM DEPT. OF PHARMACEUTICAL QUALITY ASSURANCE REG.NO: NH0117005 DATE: 14/11/2017 1
  • 2. CONTENT  Concept of Change control  Procedure of change control  Management of change control  Conditions of change control  Out of specifications(OOS)  Out of trends(OOT) 2
  • 3. CONCEPT OF CHANGE CONTROL  Change: any modification to product, document, process, equipment, instrument, system, facility etc.  Change control :procedure reviews, verifies, regulates, manages, approves and controls changes made to the existing operating system or facility or process or procedure or document or product of any combination 3
  • 4. CONCEPT OF CHANGE CONTROL  The key principles of change control are :  What was done, why, when, where, by whom, how  Results, including the impact of changes to other processes. 4
  • 5. MANAGEMENT OF CHANGE CONTROL Written procedures should be established and maintained to control changes for:  Processes, Facilities, Utilities  Methods, Validation, Computer systems  Training and training materials  Regulatory filings and Quality systems  Changes should be justified and documented.  All changes that have the potential to impact the quality, safety and efficacy should be evaluated, reviewed and approved 5
  • 8. CONDITIONS FOR CHANGE CONTROL  Revalidation  Requalification  Increased testing  Stability analysis  Document change  Regulatory action / variation application 8
  • 9. 9
  • 11. OUT OF SPECIFICATIONS (OOS) Out of Specification (OOS) means the test result that falls outside the specifications or acceptance criteria which has been specified in the official compendia monographs or the finished product specification in registration dossiers. 11
  • 12. OOS IS OBSERVED IN ANALYSIS OF:  Stability study  Finished product  In-process  Raw materials  Packing materials 12
  • 13. US FDA : GUIDELINE FOR INDUSTRY INVESTIGATING OOS TESTING RESULTS FOR PHARMACEUTICAL PRODUCTION  PHASE I: LABORATORY INVESTIGATION should include an initial assessment of the accuracy of the laboratory's data.  PHASE II: FULL-SCALE OOS INVESTIGATION consist of a production process review and/or additional laboratory work 13
  • 14. LABORATORY ERROR Laboratory error is the cause of OOS result which may occur from instrument, reagent, reference standard, environment condition, test method, analyst and calculation within laboratory. 14
  • 15. TYPES OF LABORATORY ERRORS 15
  • 16. PROCEDURE OF OOS  REPORTING TO LABORATORY SUPERVISOR  RECORDING AND NUMBERING OF OOS  INVESTIGATION BY ANALYST  LABORATORY TESTING  APPROVAL BY LAB. SUPERVISOR  TESTING BY ANALYST 16
  • 17. PROCEDURE OF OOS  PREPARATION OF TEST REPORT  EVALUATION OF SUSPECT RESULTS.  INVESTIGATION BY TECHNICAL MANAGEMENT TEAM.  CONCLUSION AND REPORT OF DATA.  EVALUATION BY QUALITY MANAGER. 17
  • 18. OOS INVESTIGATIONS  Re-testing:  The analysis of original sample at the time of phase- I laboratory investigation.  Re-sampling:  The original batch is sampled by QA second time after QA head authorization for re-analysis.  Re-analysis:  The analysis of re-sampled material for the verification of results, if manufacturing investigation does not have root cause. 18
  • 19. 19 REGULATORY IMPACT ON OOS  Stability study required  OOS should be reported to RA  OOS batch should not be sold to Regulatory market  OOS batch can not be blend with fresh approved batch  OOS batch can not be directly sell to the market
  • 21. WHAT IS OUT OF TREND (OOT) ?  A result that does not follow the expected trend, either in comparison with other stability batches or with respect to previous results collected during a stability study.  More complicated than a comparison to specification limits. 21
  • 22. CRITERIA TO CONSIDER A RESULT AS OOT !  For ASSAY: 5% Change in initial value of assay.  For IMPURITIES: Between 0.1 to 0.2 % increase or decrease as per initial reports . 22
  • 23. OOT CAN BE DUE TO:-  ASSIGNABLE CAUSE : Laboratory errors  NON- ASSIGNABLE CAUSE: Non-laboratory errors. 23
  • 24. METHOD FOR IDENTIFYING OOT  For the purpose of this study, data from ongoing stability studies of a final drug product with a shelf life of 36 months is used.  The ongoing studies were conducted on 10 batches of Product X. (solid dosage form)  The ongoing studies were conducted for 36 months in stability chambers at a constant temperature of 25 °C ± 2 °C and relative humidity of 60% ± 5% in accordance with the ICH guideline Q1A.  Analyst should carry out a assay at a time point of 0,3,6,9,12,18,24 and 36 months for all batches. 24
  • 25. TYPES OF OOT DETERMINATION:  Regression-control-chart-method. The regression-control-chart method is used to compare the results within the batch and detect present OOT results. For the purpose of this method, the tenth batch is examined.  By-time-point method. The by-time-point method is used to determine whether a result is within expectations on the basis of experiences from other batches measured at the same stability time point. 25
  • 27.  WHO, Quality Assurance of Pharmaceuticals, Vol 2, Second Edition http://www.who.int/medicines/areas/quality safety/quality_assurance /production/en/  Choudhary A. What is Change Control ? . Pharmaguideline.com. 2017 . Available from: http://www.pharmaguideline.com/2010/11/what-is-change- control.html  Fda.gov. 2017 . Available from: https://www.fda.gov/downloads/drugs/guidances/ucm070287  OOS, OOT, OOC, and OOSC Pharmtech.com. 2017 Available from: http://www.pharmtech.com/oos-oot-ooc-and-oosc 27 REFERENCE:
  • 28. 28