CONTROLLED DEVIATION REPORT

P.D.R No.            : Product Name      : Stage                    : B.No.                   : Dept.                    :

Deviation required in :   1)      Mfg. Process                    [      ]                        Vendor                                      [      ]  2)      Facility                             [      ]                        Equipment, Instrument             [      ] 3)      Materials                                                        3.1  ) Quality                     [      ]) Quanti                      [      ]

Description of deviation required (Attach additional sheet if required)

Reason for the deviation:

Deviation raised by:                                                                             Date : (Executive/Asst.)

Forward to QA

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1.0  )      Name of the departments from which the approval is required :   1.1)    Production             [     ]                          1.5)   Ware House           [     ] 1.2)        QC                         [     ]                          1.6)    QA                         [     ] 1.3)        PD                          [     ]                          1.7)    Safety &Envi.       [     ]               1.4)    Engg and Utility      [     ]                         1.8)    Plant Incharge       [     ]  2.0 )     Comments by QA QA Signature :_____________________         Date _______________ 3.0 )    Stability to be kept  :   Yes [     ]   No [      ]             Remarks :   4.0 )    Response to QA recommendations 5.0 )    Signature of Head of the Departments :                                                                                                    Signature                    Date             5.1)   Production            Approved /Not Approved    ________________    _____________                                  5.2)   QCD                     Approved /Not Approved     ________________    _____________                                  5.3)   PD                        Approved /Not Approved     ________________    _____________                                  5.4)   Engg and Utility   Approved /Not Approved     ________________    _____________                                  5.5)   Ware House          Approved /Not Approved     ________________    _____________                                       5.6)   Safety and Envi.   Approved /Not Approved     ________________    _____________ 5.7)   Plant Incharge      Approved /Not Approved     ________________    _____________                                     5.8)    QA Head             Approved /Not Approved      ________________    _____________                         AU

6.0 )   Deviation                                                           Approved/ Rejected

7.0 )Final recommendations by QA QA Sign: ________________                                                          Date: ________________ 6.0)     Signature of Head of the Departments :                                                                                                   Signature                           Date          6.1)   Production            Approved /Not Approved        ________________      ___________          6.2)   QCD                     Approved /Not Approved        ________________      ___________                             6.3)   PD lab                   Approved /Not Approved         ________________     ___________                6.4)   Engg. and Utility Approved /Not Approved         ________________     ___________          6.5)  Ware House           Approved /Not Approved         ________________     ___________          6.6)   Safety and Envi.   Approved /Not Approved         ________________     ___________          6.7)   Plant Incharge      Approved /Not Approved        ________________     ___________          6.8)   QA Head              Approved /Not Approved         ________________     ___________

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