Failure Investigation in Pharma

Rahul Kashyap


Failure Investigation in Pharma

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

Failure Investigation in Pharma

·      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:



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:




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


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)








Review of Batch Manufacturing Record (BMR)& BPR (Batch Packing Record):

(Additional sheets shall be attached, wherever required)

Check Points


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)







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:





Corrective Actions:



Preventive Actions:




Reviewed by QA:





APPROVAL(On the basis of impact on related department)





Comment (if any)









Final Review & Close out: (By QA)

Action Done

Supporting /Reference Document Number








Closure Date:








Quality Assurance Head


S. No.


Investigation  Number


Name of Product

Batch No.

Description of Failure

Suggestive CAPA

Closing Date

Sign/ Date


























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