Deviation Control in Pharmaceuticals

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

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  :- _____________________________________________________________________

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

Remarks:-________________________________________________________________________

_________________                                               _______________________

Name                                                                     Signature & Date

7.  Closer Remarks:-

Date of Implementation  :_____________________

Involved Batch No.  : ______________________

Remark : __________________________________________________________________________

_____________________                                                _______________________

Location Head QA                                                         Signature & Date

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