Get Microbiology Out of Specification (OOS) Form 680

Form 690 Issue date Microbiology Out of Specification OOS Investigation and Report Form Ref. MICLAB 110 Phase 1 Out of Limits Result Alert Limit Excursions Out of Specification Result Action Level Excursions SECTION A Product or Sample Details Unique Identifier Form Initiated by Product Description Batch Production Number BPN DR Number Product Code Limits/ Specification Original Test Result Micro Manager Notified Yes No Initial and Date Evaluation of Laboratory Testing Test Type tick MICLAB 075 MICLAB 060 KCA GEL Other Control Method reference if applicable SOP Reference Non-Sterile Testing Water Sterility Testing Endotoxin By who. Name of Technician who performed the test Training records complete Date Sampled Date Test performed Was test conducted in accordance with SOP Media/Reagents Used If No comment Lot Number Expiry Date Passed QC Checks Date Printed File Location Page 1 of 3 PART B Equipment Used Calibration Due Date Temperature Trends in range Negative Controls passed Other tests from same test session within limits Other Sources of Error Technician observations during testing N/A Are Calculations Verified and correct Test result record Attached Comments Brief Description of the date. If No is re-testing required If Yes is confirmatory or If Yes DR raised recorded in Section A Is initial Result Valid ie has root cause been identified Note If any of the above questions were answered NO an evaluation of the validity of the test needs to be conducted by the Micro Manager. Print Sign Date Approved By NOTE Refer to MICLAB 110 for appropriate Retest Procedures. PART C Retest Protocol Retest testing of Original Sample s Confirmatory Testing of Original or retention Sample s for Retest of Retain samples Retest of Both Original and retain sample Number of Replicates to be Tested Test Method Limits for Retest Retesting Conducted by Sign and Date Please document the purpose of additional testing as detailed above. Name of Technician who performed the test Training records complete Date Sampled Date Test performed Was test conducted in accordance with SOP Media/Reagents Used If No comment Lot Number Expiry Date Passed QC Checks Date Printed File Location Page 1 of 3 PART B Equipment Used Calibration Due Date Temperature Trends in range Negative Controls passed Other tests from same test session within limits Other Sources of Error Technician observations during testing N/A Are Calculations Verified and correct Test result record Attached Comments Brief Description of the date. If No is re-testing required If Yes is confirmatory or If Yes DR raised recorded in Section A Is initial Result Valid ie has root cause been identified Note If any of the above questions were answered NO an evaluation of the validity of the test needs to be conducted by the Micro Manager. If No is re-testing required If Yes is confirmatory or If Yes DR raised recorded in Section A Is initial Result Valid ie has root cause been identified Note If any of the above questions were answered NO an evaluation of the validity of the test needs to be conducted by the Micro Manager. Print Sign Date Approved By NOTE Refer to MICLAB 110 for appropriate Retest Procedures. PART C Retest Protocol Retest testing of Original Sample s Confirmatory Testing of Original or retention Sample s for Retest of Retain samples Retest of Both Original and retain sample Number of Replicates to be Tested Test Method Limits for Retest Retesting Conducted by Sign and Date Please document the purpose of additional testing as detailed above. .