Deviation Control in Pharmaceuticals

1           As for as possible there shouled not be any deviation in either manufactuting or Pacing process.
2           Deviation may be planed and unplanned If there is any deviation then it should be categorized  as either
minor or major deviation.
3           In case of minor devistion in the Manufacturing Process which does not affect the final parameters of the
product or its quality or its stability. The deviation should be authorized by manager of production & Q.A.
Department and them only carry out the process.
4          Minor batch deviation (with authorization) should be limited to the particular batch only so that the batch
may be completed.
5          After minor deviation, if the specifications of the product are changed, then the clanges should be recorded /
regularized / and authorized by Technical director.
6           In case of major deviation in the Mfg./Pkg. Process  e.g.(i) any change of RM or its supplier and its quantity
per batch; (ii) any change of primary packing material or its supplier.
7           The change should be validated for three consecutive batches.
8           The change should be studied for stability purpose. In case of Loan licence party stability shall be conducted
by concerned party.
9          On the basis of vaidation & stability studies data the change should be authorised by Technical Director or
Q.A. Manager before its implementation in the regular batches.
10        A Detailed report about the investigation and the deviation shall be prepared & kept in file for further
reference.

            Procedure for Raising deviation Report.

1          Request for deviation shall be raised by manager of respective department. In the approved format (Annexure
1) with justification for deviations.
2          The location head Technical director shall comment on the deviation.
3          Comments by Regulatory & product development deptt. Are made whether validation. Stability study for
change control required or not.
4          Decision regarding approval / non approval of the deviation shall be taken by Q.A. Manager in case of loan
licenses party or by technical director in case of Promed product.
5          Closer remark shall be made mentioning B.No. & date of completion.

Annexure   -1
DEVIATION REPORT
1         Deviation Report Number ....................................
2         Name of Munufacurer............................................
3         Product Details
Product Batch No. Market. Pack Size. Mfg.Date Exp.Date

           Types of Deviation  :-

                                   Planned                                                          Unplanned

 Description of Deviation
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Stage
.............................................................................................................................................
.............................................................................................................................................
Observed by  :-
.............................................................................................................................................

6.             Justification  :-
            (Attach investigation report in case of un planned deviation / additional
              paper if requierd )
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
............................................................................................................................................

               ____________________                        __________________        __________________

               Mfg. Location                               Initiated by (Name)            Signature & Date
7.            Comments by Location Head :
............................................................................................................................................
............................................................................................................................................
         Location Head (Name)                                                   Signature & Date
         ___________________                                      __________________________
8.            Comments by DRA (for L L Product)
............................................................................................................................................
............................................................................................................................................
__________________                                                                  ________________________

        Name                                                                                                            Signature  & Date

............................................................................................................................................
9.            Comments by PDL ( For Loan Lic. Product) Location Head Q.A.
         Validation Required                               Yes                                          No.

         Stability Study Required                       Yes                                          No.

         Change Control Required                     Yes                                          No.     

...........................................................................................................................................
...........................................................................................................................................
        ___________________                                                        _________________________
                Name                                                                                        Signature & Date
6.             Decision by Q.A.M

         Approved                                                     Non Approved

 Remarks:-...............................................................................................................................
........................................................................................................................................
         _________________                                                       _______________________
                  Name                                                                                      Signature & Date

7.             Closer Remarks:-

         Date of Implementation  :      ..........................................

         Involved Batch No.  :.......................................................
         Remark :
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................

         _____________________                                                   _______________________

             Location Head QA                                                                      Signature & Date