1.1To define the standard operating
procedure for the rework of Intermediate/API.
2.1Head Quality Control
2.2Head Quality Assurance
3.1Definition of rework
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.
3.2Whenever 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
for failure and investigation there off.
the batch is to be reprocessed or reworked to bring it up to the specification.
stability study will be required?
any specific controls to be exercised during rework in case it is to be reworked.
3.3Based on the outcome of this discussion
if rework is recommended then following procedure is adopted.
3.4Based 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
3.5It is also determined whether the
situation is likely to occur again.
3.6If 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.
3.7This 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.
3.9The rework protocol is documented along
with any control measure and records that are to be made to ensure compliance
to the protocol.
draft manufacturing record shall be prepared by production on the basis of recommendation
of QA, QC and R&D.
number shall be assigned as per Batch numbering SOP
reworked batches shall be suitably identified so as to make it explicitly clear
about their status as a reworked batch.
the batch is reworked, the batch is analysed for it compliance with specifications.
final test report is issued to production from QC after compliance of product
of impurity profile of each reworked batch against batches manufactured by the
established process to be done.
routinely analytical method are inadequate to characterise the reworked batch, additional method should be used from approved accredited laboratory.
documents are prepared and archived with the BMR to describe the reason, steps
taken and result.
accelerated stability studies of reworked batches will be undertaken if the
method used in unique and has not been studied for stability earlier.
reworked batches may be released for commercial purposes if the quality of such
batches is similar to the normal production batches.