1. OBJECTIVE
To describe the procedure for reprocessing of intermediate or API, which does not confirm to the standards or specifications.
2. RESPONSIBILITY
Head QA
Head QC
Head Production
3. PROCEDURE
Definition of Reprocessing
Introducing an intermediate or API, including one that does not conform to standards or specification, back into the process that are part of established manufacturing process is generally consider acceptable. However, if such reprocessing is used for a majority of batches, such reprocessing should be included as part of the standard 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. This is not considered to be reprocessing.
Introducing an unreacted material back into the process and repeating a chemical reaction is considered to be reprocessing unless it is part of the established process. Such reprocessing should be preceded by careful evaluation to ensure that the quality of the intermediate or API is not adversely affected due to the potential formation of by product and over reacted material
Unless otherwise required, reprocessing shall follow the laid down procedure.
The Active pharmaceutical ingredient and the intermediates that do not conform the specification should be subjected to reprocessing or reworking based on the decision of the committee.
Based on the reprocessing procedure, production department shall prepare the BMR/ BPR which will be approved by Quality Assurance for implementation.
Head QA shall approve the proposed reprocessing activity in consultation with Head QC and Head Production.
Allot a new batch number to the reprocessed batch as per the batch numbering system SOP.
The addtional BPR shall be linked with the existing Batch record.
The final product shall be analyzed by Quality Control.
The reprocessed batch shall be analyzed and released by Quality Assurance.
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. This is not considered to be reprocessing.
Introducing an unreacted material back into the process and repeating a chemical reaction is considered to be reprocessing unless it is part of the established process. Such reprocessing should be preceded by careful evaluation to ensure that the quality of the intermediate or API is not adversely affected due to the potential formation of by product and over reacted material
Unless otherwise required, reprocessing shall follow the laid down procedure.
The Active pharmaceutical ingredient and the intermediates that do not conform the specification should be subjected to reprocessing or reworking based on the decision of the committee.
Based on the reprocessing procedure, production department shall prepare the BMR/ BPR which will be approved by Quality Assurance for implementation.
Head QA shall approve the proposed reprocessing activity in consultation with Head QC and Head Production.
Allot a new batch number to the reprocessed batch as per the batch numbering system SOP.
The addtional BPR shall be linked with the existing Batch record.
The final product shall be analyzed by Quality Control.
The reprocessed batch shall be analyzed and released by Quality Assurance.
4. ABBREVIATIONS
QA-Quality Assurance
BMR-Batch manufacturing record
BPR- batch Packaging record
API-Active pharmaceutical ingredients
5. ANNEXURES
Nil
6. REFRENCES
ICH Q7 Guidelines section 14.2
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