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.
5.7.1
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.
6.0 ANNEXURES:
Annexure 1: Record
of Re-process Batch.
Annexure: 1
Record
of Re-process Batch
|
RECORD OF RE-PROCESS
BATCH
|