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

 


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