Deviation Control in Pharmaceuticals : Pharmaguideline

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Deviation Control in Pharmaceuticals

Learn the procedure for deviation in Pharmaceuticals - Planned and Unplanned deviation.
1. As for as possible there should not be any deviation in either manufacturing or Packing process.
2. Deviation may be planned and unplanned If there is any deviation then it should be categorized as either minor or major deviation.
3. In case of minor deviation 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 changes 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 validation & stability studies data the change should be authorized 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.
Related: Difference between Incidence and Deviation
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
1.  Deviation Report Number ___________________
2.  Name of Munufacurer ______________________
3.  Product Details
Batch No.
Pack Size.
Types of Deviation  :-
Planned                                    Unplanned

Description of Deviation_______________________________________________________________
Observed by  :- _____________________________________________________________________
4.  Justification  :- ___________________________________________________________________
 ___________________              __________________             __________________
Mfg. Location                    Initiated by (Name)             Signature & Date

5.  Comments by Location Head : _______________________________________________________

Location Head (Name)                                            Signature & Date
___________________                                                 _______________________

6.  Decision by Q.A.M

         Approved                                                     Not Approved

_________________                                               _______________________
Name                                                                     Signature & Date

7.  Closer Remarks:-
Date of Implementation  :_____________________
Involved Batch No.  : ______________________
Remark : __________________________________________________________________________
_____________________                                                _______________________
Location Head QA                                                         Signature & Date

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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