SOP FOR REPROCESS OF API OR INTERMEDIATE

I.                   PURPOSE

To describe the procedure for reprocessing of Intermediate or API, which does not conform to the standards or specifications.

II.                SCOPE

This procedure is applicable to all the Intermediates / APIs manufactured at COMPANYS, Unit – V.

III.             RESPONSIBILITY

Research Scientist

Head - Quality Assurance

Head - Process Development Lab

            Head - Production

            Head - Quality Control

IV.             ACCOUNTABILITY

Head QA

V.                PROCEDURE

1.0        Definition of Reprocess:

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, milling) that are part of the established manufacturing process.

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.

2.0        Active Pharmaceutical Ingredients and Intermediates that do not conform the specifications should be subjected to reprocessing or reworking.    

3.0                   Perform an investigation as per the “Handling of OOS Results” SOP before deciding the reprocessing of a batch.

4.0       Based on the nature of the problem or reasons for failure QA should recommend the Process Development Lab to generate the procedure for reprocessing.

5.0       Quality Assurance department must review the reprocessing procedure.

7.0       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.

8.0       Process Development lab and Quality Assurance should monitor the yield and quality of the batch taken for reprocesses.

9.0       Allot a batch number to the reprocessed as per the Batch numbering system SOP.

10.0     If the batch complies with the specifications then keep the samples for stability studies.

11.0          After the completion of 3 months of stability studies release the approved reprocessed      batch.

12.0          Reprocessed material should not be despatched to the regulatory market.

13.0          If the batch is not approved after reprocessing or rework, forward the details to Process       Development lab for further action.

14.0   If Process Development lab is unable to develop a procedure for reprocessing then               destroy the material by incineration.

VI.      REVISION SUMMARY

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