Monday, September 19, 2016

SOP ON REPROCESSING

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.

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


Also read