SOP for Reprocessing of Out of Specification Batch

Purpose

To provide instructions for Batch Reprocessing of Specification Batch.

Objective

To Provide a Documented Procedure for Batch Reprocessing of out of Specification Batch.

Scope

This procedure is applicable for batch reprocessing of an out-of-specification batch.

Responsibility

Production Manager

Q.A In charge

Procedure

• Collect the batch from the Quarantine area which is in the hold by Q.A for out-of-specification batches.
• Confirm the reason for out of specification, by referring the note received from Q.A Department.

• Fill the Deviation Form for the said batch and action to be taken for re-processing, after approval from Q.A and G.M, Manufacturing proceed for further action of re-processing.
• If batch is in hold for any physical defect then the following procedure should be followed.
• Check the physical parameters of the batch as per specification and confirm for compliance with the parameters and record the observation in Annexure-1.
• Further batch processing should be carried out as per procedure given in Batch Manufacturing Record.

General Conditions & Precautions

• Ensure that the Batch is out of specification.
• For Identification of Re-processed Batch, Batch No. are added with prefix "R" Re-presenting Re-process in all areas where batch details are being mentioned.
• All the containers should be labeled with "UNDER PROCESS" when the batch is in the hold. Till the Q.C Department approves and release the batch for its compliance with the quality standards the re-processed batch shall not to be taken for further procedure of packing neither for primary packing nor for secondary packing.
• A separate Batch Manufacturing Record shall be generated for the Re-processed Batch.

Annexure

Revision History 

Nil

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