REPROCESSING REWORKING

1.0    PURPOSE:
         
    To  describe a  standard operating procedure (SOP) for reprocessing/ reworking  of  any  non-conforming  intermediate or finished product.
        

2.0    SCOPE:
    
    The SOP describes in detail the method of reprocessing/reworking.
    
3.0    RESPONSIBILITY:
    
    The responsibility of reprocessing/reworking lies with the staff of the  rank not lower than operator of the production department.
    
    The responsibility of preparing, reviewing and approving the SOP lies with the Executive (Production), Head of Production and Head of QAD  respectively.
    
4.0    METHOD:
    
4.1    The batches of drug products or intermediates that are rejected  by the QCD are reviewed to determine whether they can  be reprocessed/reworked to bring back for  compliance with the specifications.
    
4. 2    To make a  decision,  discussion will be held  among  the  Head of R&D,  Head of Production   and  Head of QAD.
    
4. 3    If the decision is  to reprocess/rework the material, the same will be communicated to the Incharge of the block, after duly signed by the Chiefs of Production and QCD along  with  a copy of analytical report.
    
4. 4    The  method  of reprocessing/reworking will be given  by  the Head of R&D.
    
    
4. 5    The  reprocessed / reworked material will be given the  same  batch No.  with suffix R, R1......, for 1st & 2nd .....  respectively and then sampled and tested by QCD.  After    approval from QCD, the  reprocessed/reworked material will be treated as  a  fresh batch.
    
4. 6    The  reprocessing / reworking  and testing have to  be  completed within a month after rejection.
    
4.7    The first batch of the reprocessed/reworked material shall be kept for accelerated / long-term stability studies. 
4.8    
    If there is any change in the method of reprocessing/reworking then also the  first batch of the changed method shall be kept for accelerated /  long-term stability studies.
    
5.0    RECORDING:
    
    All the records pertaining to this have to be maintained by the staff of the rank not lower than Executive of Production.
    
    

Reprocessing reworking, production