SOP for Handling of Rejected Batches in the pharmaceutical industry

SOP for Handling Of Rejected Batches In Pharma Industry

Every organization is having its own SOP on the handling of rejected batches. Let’s understand common practices are followed by the organizations.

1. Objective

To lay down a procedure for initiation and approval of batch rejection note along with transfer of rejected batch from production/quarantine area in finished goods WH to scrap hold area in production / rejected batch hold area in the warehouse.

2. Scope

This procedure is applicable for the pilot, clinical, exhibit and commercial batches rejected at formulation.

3. Responsibilities

QA- For initiation of batch rejection note and paste rejected label on rejected batch container/shipper.

Production- To ensure the semi-finished bulk is under hold in respective hold area and is transferred to scrap area and kept under hold till approval of rejection note.

Warehouse- For ensuring the transfer of rejected finished good batch from quarantine area in the finished good warehouse to reject hold area in the warehouse.

Warehouse/production personnel to receive/store/send the rejected batch for destruction.

QA Head/designee and Production Head/Designee- To approve the rejection note.

Plant Head/Designee- To authorize the rejection note.

QA Head- To ensure compliance.

4. Abbreviations

OOS-Out of Specification

QA-Quality Assurance

SAP-System Application Product

BPR-Batch Production Record

FGWH-Finished Good Warehouse

No.- Number

SOP-Standard Operating Procedure

Also Read:

What is ICH Q10 in pharmaceutical industry

What is S1 S2 and S3 in Dissolution

5. Procedure

  1. Based on the OOS/Incident report, QA personnel shall initiate the rejection note in the SAP and affix the rejection label on the container of the rejected batch.
  2. If the batch to be rejected is available in the production area, QA personnel shall forward the task to the production department for preparatory work required for transfer of rejected batch to scrap hold area.
  3. If the batch to be rejected in the finished good warehouse, QA personnel shall forward the task to the warehouse department preparatory work required for transfer of rejected batch to reject hold area of the warehouse.
  4. Production personnel shall transfer the rejected batch into suitable containers, if required, and affix the status label on the individual container.
  5. Production/warehouse personnel shall enter the weighing details of the quantity to be rejected in rejection notification and the quantity shall be reconciled. The reconciled quantity shall be verified by QA personnel.
  6. QA Personnel shall affix the Rejected label on each container and forward the task to Production Head/Designee, QA Head/Designee, and Plant Head/Designee for their approvals.
  7. Upon approval of the batch rejection note, the production officer shall arrange to transfer the batch from the production area to the scrap hold area. And if the batch is available in the finished goo warehouse, the officer-in-charge shall arrange to transfer the batch to the reject hold area in the warehouse.
  8. In the case of control samples collected for the rejected batch, shall be evaluated for rejection.
  9. Batch rejection note report can b down-loaded/printed from SAP.
  10. One copy of the batch rejection note shall be attached to the batch record.
  11. Batch rejection note notification log is available in SAP and viewed.

This is a SOP for Handling of rejected batches in pharmaceuticals.

Handling Of Rejected Batches

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