SOP for Handling of Rejected Batches

Objective

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

Scope

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

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 the respective hold area and is transferred to the scrap area and kept under hold till approval of rejection note.
• Warehouse: For ensuring the transfer of rejected finished good batch from the quarantine area in the finished good warehouse to the 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.

Procedure

• During testing, if the batch gets rejected, the QC analyst shall generate a rejected batch certificate of analysis (CoA) and rejection labels according to the number of containers.
• 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.

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• 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 the transfer of the rejected batch to the scrap hold area.
• If the batch is to be rejected in the finished goods warehouse, QA personnel shall forward the task to the warehouse department for preparatory work required for the transfer of the rejected batch to the reject hold area of the warehouse.
• Production personnel shall transfer the rejected batch into suitable containers, if required, and affix the status label on the individual container.
• Production/warehouse personnel shall enter the weighing details of the quantity to be rejected in the rejection notification and the quantity shall be reconciled. The reconciliation quantity shall be verified by QA personnel.
• QA Personnel shall affix the Rejected label on each container and forward the task to the production Head/Designee, QA Head/Designee, and Plant Head/Designee for their approval.
• 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. 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.
• In the case of control samples collected for the rejected batch, shall be evaluated for rejection.

• Batch rejection note reports can be downloaded/printed from SAP.
• One copy of the batch rejection note shall be attached to the batch record.
• The batch rejection note notification log is available in SAP and viewed.

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

Revision History

Nil

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