Sunday, 26 September 2021

Failure Investigation in Pharma

 

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:

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.

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