SOP for Deviation Control : Pharmaceutical Guidelines

SOP for Deviation Control

Standard operating procedure for deviations occurred during the manufacturing process in pharmaceutical manufacturing facilities.

1.0 OBJECTIVE

To lays down a procedure for change control.

2.0 SCOPE

This is applicable to the all the products manufactured at the manufacturing facility covering the manufacturing, packaging and in-process activities.

3.0 RESPONSIBILITY

QA Chemist

4.0 ACCOUNTABILITY

QA Manager 

5.0 PROCEDURE

5.1 As for as possible there should not be any deviation in either manufacturing or packing process.
5.2 Deviation may be planed and unplanned If there is any deviation then it should be categorized as either minor or major deviation.
5.3 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 the manager of production & Q.A. Department and they only carry out the process.
5.4 Minor batch deviation (with authorization) should be limited to the particular batch only so that the batch may be completed.
5.5 After mia nor deviation, if the specifications of the product are changed, then the changes should be recorded/regularized / and authorized by the Technical Director.
5.6 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.
5.7 The change should be validated for three consecutive batches.
5.8 The change should be studied for stability purpose. In case of loan licence party stability shall be conducted by concerned party.
5.9 On the basis of validation & stability studies data the change should be authorized by the Technical Director or Q.A. Manager before its implementation in the regular batches.
5.10 A Detailed report about the investigation and the deviation shall be prepared & kept on the file for further reference.
5.10.1 Procedure for Raising deviation Report.
5.10.2 Request for deviation shall be raised by the manager of the respective department. In the approved format (Annexure 1) with justification for deviations.
5.10.3 The location head Technical director shall comment on the deviation.
5.10.4 Comments by Regulatory & product development deptt. Are made whether validation. Stability study for change control required or not.
5.10.5 Decision regarding approval / non-approval of the deviation shall be taken by Q.A. Manager in case of loan licenses party or by the technical director in case of Promed product.
5.10.6 Closer remark shall be made mentioning B.No. & date of completion.

6.0 ABBRIVATIONS

6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance


Annexure -1
DEVIATION REPORT

1. Deviation Report Number ....................................
2. Name of Manufacturer............................................
3. Product Details
Product
Batch No.
Market.
Pack Size.
Mfg.Date
Exp.Date







4. Types of Deviation:
                                   Planned                                                           Unplanned

5. Description of Deviation
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
6. Stage
.............................................................................................................................................
.............................................................................................................................................

7. Observed by
.............................................................................................................................................

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

.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................

____________________          __________________           __________________
Mfg. Location                               Initiated by (Name)                 Signature & Date


Comments by Location Head
............................................................................................................................................
............................................................................................................................................

Location Head (Name)                                  Signature & Date

___________________                  ______________________


Comments by DRA (for L L Product)
............................................................................................................................................
............................................................................................................................................

__________________                                       ________________________
Name                                                                              Signature & Date


Comments by PDL ( For Loan Lic. Product) Location Head Q.A.


         Validation Required                               Yes                                         No.

         Stability Study Required                        Yes                                         No.
 



9. Change Control Required                     Yes                                         No.     

...........................................................................................................................................
...........................................................................................................................................

        ___________________                                                        _________________________
                Name                                                                                        Signature & Date

10. Decision by Q.A.M
 
         Approved                                                    Non Approved

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

11. Closer Remarks:

         Date of Implementation  :     ..........................................
        
         Involved Batch No.  :.......................................................

         Remark :
...........................................................................................................................................

...........................................................................................................................................

...........................................................................................................................................

         _____________________                                                   _______________________
             Location Head QA                                                                     Signature & Date

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, 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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