Reprocessing of Intermediate or API, which does not confirm to the standards or specifications
1.0 OBJECTIVE:
To
lay down the procedure for reprocessing of Intermediate or API, which does not
confirm to the standards or specifications.
2.0 SCOPE:
This
SOP shall be applicable to all the Instruments/ APIs manufactured at
Pharmaceutical Industry.
3.0 RESPONSIBILITY:
3.1
Officer/
Executive/ Assistant Manager.
4.0 ACCOUNTABILITY:
4.1
Head of Quality
Assurance Department.
4.2
Head of Production
Department.
4.3
Head of Quality
Control Department.
5.0 PROCEDURE:
5.1 Definition of
Reprocess:
5.1.1
Introducing an
intermediate or API that does not conform to the standards or specifications,
back into the process and repeating a crystallization step or other appropriate
chemical or physical manipulation steps (e.g., distillation, filtration,
chromatography, and milling) that are part of the established manufacturing
process.
5.1.2
Continuation of a
process step after an in-process control test has shown that the step is
incomplete is considered to be part of the normal process, and not
reprocessing.
5.2 Active
Pharmaceutical ingredients and intermediates that do not confirm the
specifications should be subjected to reprocessing or reworking.
5.3 Perform
an investigation as per the “Handling of OOS Results” SOP before deciding the
reprocessing of a batch.
5.4 Based
on the nature of the problem or reasons for failure QA should recommend the
Process development Lab to generate the procedure for reprocessing.
5.5 Quality
Assurance department must review the reprocessing procedure.
5.6 Based
on the reprocessing procedure, Process development lab and production
department should prepare the Batch Production Control Record, which will be
approved by Quality Assurance for implementation.
5.7 Process
Development lab and quality Assurance should monitor the yield and quality of
the batch taken for reprocesses.
5.8 Allot
a batch number to the reprocessed as per the batch numbering system SOP.
5.9 If
the batch complies with the specifications then keep the samples for stability
studies.
5.10 After
the completion of 3 months of stability studies release the approved
reprocessed batch.
5.11 Reprocessed
material should not be dispatched to the regulatory market.
5.12 If
the batch is not approved after reprocessing or rework, forward the details to Process
Development lab for further action.
5.13 If
Process Development lab is unable to develop a procedure for reprocessing then
destroy the material by incineration.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
|
New
SOP |
7.0 REFERENCES:
7.1
Not Applicable.
8.0 ANNEXURES:
8.1
Not Applicable.
9.0 ABBREVIATIONS:
|
Abbreviation |
Expanded Form |
|
SOP |
Standard operating
procedure |
|
& |
And |
|
No. |
Number |
|
Ltd. |
Limited |
|
QA |
Quality assurance |
|
F |
Format |
|
API |
Active pharmaceutical
ingredient |
|
OOS |
Out of specification |