Wednesday, September 7, 2016

SOP on Rework

1.0            OBJECTIVE

1.1  To define the standard operating procedure for the rework of Intermediate/API.

2.0            RESPONSIBILITY

2.1            Head Quality Control

2.2            Head Quality Assurance

2.3            Head Production

3.0            PROCEDURE
3.1            Definition of rework
3.1.1     Subjecting an intermediate or API that does not conform to  standard or specifications to one or more processing steps that are different from the established manufacturing process to obtain the acceptable quality intermediate or API.

3.2     Whenever a product is found out of specification or non conform, depending upon the nature of failure, a discussion is held between QA, Production, QC and R&D to determine the following:
 3.2.1       Reason for failure and investigation there off.
 3.2.2    Whether the batch is to be reprocessed or reworked to bring it up to the specification.
3.2.3 Whether stability study will be required?
3.2.4 Whether any specific controls to be exercised during rework in case it is to be reworked.

3.3       Based on the outcome of this discussion if rework is recommended then following procedure is adopted.
3.4    Based on the area of non-compliance, production Incharge determines reworking program or method of non conforming batch/material in consultation with quality assurance, quality control and if needed be with R & D.
3.5            It is also determined whether the situation is likely to occur again.
3.6         If it is found to be one –off situation proper technical study is undertaken for the efficacy of the rework protocol in achieving the rework objectives.
3.7          This protocol is adopted only if its technical soundness is fully established.
3.8     If however it is found that the non conforming situation is such that it may occur again, in that case the rework protocol is suitably validated before adoption.
3.9       The rework protocol is documented along with any control measure and records that are to be made to ensure compliance to the protocol.
3.10       A draft manufacturing record shall be prepared by production on the basis of recommendation of QA, QC and R&D.
3.11       Batch number shall be assigned as per Batch numbering SOP
3.12       All reworked batches shall be suitably identified so as to make it explicitly clear about their status as a reworked batch.
3.13  After the batch is reworked, the batch is analysed for it compliance with specifications.
3.14    A final test report is issued to production from QC after compliance of product with specification.
3.15    Comparison of impurity profile of each reworked batch against batches manufactured by the established process to be done.
3.16   Where routinely analytical method are inadequate to characterise the reworked batch, additional method should be used from approved accredited laboratory.
3.17       Adequate documents are prepared and archived with the BMR to describe the reason, steps taken and result.
3.18       The accelerated stability studies of reworked batches will be undertaken if the method used in unique and has not been studied for stability earlier.
3.19       The reworked batches may be released for commercial purposes if the quality of such batches is similar to the normal production batches.


4.0            ABBREVIATION
 4.1            NIL

5.0            ANNEXURES
 5.1            NIL

6.0            REFERENCE
6.1            ICH Q7 14.30,14.31,14.32


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