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Release Coordinator Audit 2

  1.  
    What SOP governs the site's General Release Procedures?
  2.  
    Who can approve a "Greater than 1" for NCR Lot Disposition?
  3.  
    Which of the following testings are NOT included for QFL56 (Fill samples by batch)
    A. Pyrogen B. Enviromental C. PM D. Final Chemical E. Initial Chemical F. DA (Direction Sheet Accountability) G. RR (Product Retrieval Request) H. QM (Quality Inspection)
  4.  
    Who must approve a comment made after doc center review?
  5.  
    What should we check before creating a sublotted batch in GME?
  6.  
    To drop a batch, what are 3 items that we need to check?
  7.  
    What is the retention period for Membrane Logs (NC-MB-003)
Answer Key
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Release Coordinator Audit 2 (Answer Key)

  1.  
    What SOP governs the site's General Release Procedures?
  2.  
    Who can approve a "Greater than 1" for NCR Lot Disposition?
  3.  
    Which of the following testings are NOT included for QFL56 (Fill samples by batch)
    A. Pyrogen B. Enviromental C. PM D. Final Chemical E. Initial Chemical F. DA (Direction Sheet Accountability) G. RR (Product Retrieval Request) H. QM (Quality Inspection)
  4.  
    Who must approve a comment made after doc center review?
  5.  
    What should we check before creating a sublotted batch in GME?
  6.  
    To drop a batch, what are 3 items that we need to check?
  7.  
    What is the retention period for Membrane Logs (NC-MB-003)

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