DEVIATION FROM YIELD RANGE

1.0    PURPOSE:
    
        To describe a  standard operating procedure (SOP) for deviation  from yield range for all products / intermediates  manufactured  
    
2.0    SCOPE:
    
        The  SOP describes in detail  the method to be followed for deviation from yield range for intermediates of all stages and for all the products manufactured 
    
3.0    RESPONSIBILITY:
    
        The  responsibility   of reporting deviation from  yield  range  as per the SOP lies  with the staff of rank not lower than  operator of production department.
    
         The responsibility of preparing, reviewing and approving the SOP lies with the Officer (Production), Head of Production and Head of QAD  respectively.
    
4.0    METHOD:
    
4.1    Deviation from yield range will be informed by production staff of rank not lower than production supervisor to Head of produc tion and Head of QAD.
    
4.2    Head of production will investigate the reasons (parameters are  furnished in annexure - I) for deviation and prepares a report. If  reason for deviation is unidentified, he will instruct  the  production  executive to keep aside 100 g of the  material  for  further testing (if required).  Head of production will  inform  to Head of R&D / PID,  manager (QC) and Head of QAD, the devia tion from yield range along with his investigation report, once after the yield is known.
    
4.3    After  receipt of report from Head of Production, Head  of  QAD  will carry  out independent investigation.
    

4.4    If reason for deviation is unidentified, Head of QAD  alongwith  Manager (QC)  will carefully  review the analytical profile  of  the material.  If the impurity profile is similar to the normal batches, manager QC will give clearance to production  manager/  Head of production to take the material for further processing. If the  impurity  profile  is different  from the normal batches, Head of QAD will ask Head of production to send the material to manager (QC) for retesting.
    
4.5    Head  of QAD in consultation with Head of production,  Head  of  (R&D) / PID and manager (QC), will advise the steps to be taken  to  control deviations from yield range if the cause of  deviation is known.
    
4.6    If  the product does not meet the approved  specifications,  it will  be  processed  as per  non-conforming  product  procedure  
    
5.0    RECORDING:
    
        The  investigation reports of Head of producion, and  Head of QAD will be intimated to Head of R&D / PID and manager QC  and  will be kept on record.
 

Production, deviation, yield range