Failure Investigation in Pharma

Any batch failed to meet the acceptance criteria shall be evaluated as per Out of specification SOP

·      When Out of Specification report received from Quality Control, Quality Assurance shall log in the Failure Investigation after confirmation of OOS result.

·       Executive/Designee-QA shall allocate the Investigation as below and record in log book as per Format given at the end of this SOP

·       For investigation, QA shall issue the Failure Investigation Report as per Format No.  given at the end of this SOP by assigning the Failure Investigation Report number. Failure Investigation Report shall be filled by concerned department for joint investigation.

·       After log in the Failure investigation report, QA shall immediately inform to Production Head regarding batch failure.

·       Investigation shall be carried out by technical team comprising of Production, Quality Control and Quality Assurance.

·       Investigation shall be initiated within 24 hours and completed within a week to find out reason for failure.

·       The batch record and supporting document shall be reviewed as per checklist and record observations as mentioned below

·       Based on review of above data, technical team shall recommend proposed action for batch i.e. Rework or reject / destroy.

·        Impact of this shall be assessed on other batches /product by QA with technical team and appropriate CAPA shall be taken.

·       Failure Investigation shall be closed based on root cause analysis and after implementation of CAPA.If the batch is rejected, QA shall affix the status label ‘REJECTED’ in red color on whole batchQA shall not release the batch for further processing / packing/dispatch and respective batch record shall be stamped as  “REJECTED” in red color.

FAILURE INVESTIGATION REPORT Failure Investigation in Pharma (To be filled by QA)
Investigation Number:					Date:
Product Name:					Batch Number:
Mfg. Date:					Exp. Date:
(To be filled by originator)
Nature of Failure and Stage at which problem occurred:
Test Performed:
Actual Results:
Standard:
Probable Reason:
Investigation Checklist:
Investigation to be carried out on following criteria but not limited to: (Additional sheets shall be attached, wherever required) Ø  Used Raw/Intermediate Material Validity Ø  Review of Batch Manufacturing Record Ø  Process Deviations Ø  Other Criteria for Failure Ø  Summary of the Data /Results Ø  Conclusion Ø  Suggested Corrective Actions
Used Raw Material Validity: (Additional sheets shall be attached, wherever required)
Check points				Status
Are all raw material received from approved vendor?
Analytical report of Raw Material
Check the accountability/ inventory of Raw Material
Is Raw Material stored in proper storage condition?
Source of RM used
AR No. of RM Used
Potency Calculation
Findings (If Any)
Warehouse Sign/Date:				QA Sign/Date:
Review of Batch Manufacturing Record (BMR)& BPR (Batch Packing Record): (Additional sheets shall be attached, wherever required)
Check Points				Status
Check existing validated process?
Batch manufacturing as per the current and approved master production formula and process
Raw materials (approved vendor Status)
Critical steps during manufacturing / processing to be witnessed by responsible supervisor
Is there any major deviation noticed during process?
Check the calculation and consumption of RM
Is counter check done by production during material addition?
All the steps followed as per instructions in the BMR/BPR?
Temperature and Relative Humidity of process area
% Yield of Bulk & Finished Product
Testing and Release
In process sampling
Equipment cleaning and usage log books
Finished product sampling
Temperature and Humidity of primary packing area
Is the final yield within limits?
Non-Viable particle count in aseptic areas
Environment monitoring results and trend
Visual inspection results/rejects
Pressure differential monitoring records
Water system control
Findings (If Any)
Production:  Sign/Date:				QA: Sign/Date:
Review of actual work habits Vis-à-Vis compliance of the operation SOPs.
Review of Observation		Deviation Observed					Remarks / Comments / Results
Other Criteria of Failure: (Additional sheets shall be attached, wherever required)
Summary of the Data / Results:
Conclusion:
Corrective Actions:
Preventive Actions:
Reviewed by QA:       Sign/Date:
APPROVAL(On the basis of impact on related department)
Name	Designation		Department	Sign/Date		Comment (if any)
Final Review & Close out: (By QA)
Action Done				Supporting /Reference Document Number
Closure Date:             Sign/Date: Quality Assurance Head

FAILURE INVESTIGATION LOG BOOK

S. No.	Date	Investigation  Number	Department	Name of Product	Batch No.	Description of Failure	Suggestive CAPA	Closing Date	Sign/ Date