Batch Re-processing SOP in Pharmaceuticals Industry

Standard operating procedure for instructions of Batch Reprocessing of out of specification Batch in this post.

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1.0 OBJECTIVE:

To lay down the procedure for the instructions of Batch Reprocessing of out of specification Batch.

2.0 SCOPE:

This SOP shall be applicable for batch reprocessing of out of specification batch.

3.0 RESPONSIBILITY:

3.1 Primary: Production Manager.

3.2 Secondary: Q.A. Manager.

4.0 ACCOUNTABILITY:

4.1 Head of Quality Assurance Department.

4.2 Head of Production Department.

5.0 PROCEDURE:

5.1 Collect the batch from Quarantine area which is in hold by Q.A for out of specification batch.

5.2 Confirm the reason for out of specification, by referring the note received from Q.A Department.

5.3 Fill the Deviation Form the side 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.

5.4 If batch is in hold for any physical defect then following procedure should be followed.

5.5 Check the physical parameters of batch as per specification any confirm for compliment with the parameters and record the observation in the Annexure-1.

5.6 Further processing of batch should be carried out as per procedure given in Batch Manufacturing Record.

5.7 General Conditions & Precautions:

5.7.1 Ensure that the Batch is out of specification.

5.7.2 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.

5.7.3 All the containers should be labeled with “UNDER PROCESS” label when the batch is in 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.

5.7.4 Separate Batch Manufacturing Record shall be generated for the Re-processed Batch.