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SOP for Deviation Control

Standard operating procedure for deviations occurred during the manufacturing process in

pharmaceutical manufacturing facilities.

Ankur Choudhary  Print  Question Forum  No comments

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

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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 [Link]. & 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. [Link] [Link]

4. Types of Deviation:

                                   Planned                                                           Unplanned

5. Description of Deviation

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

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

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

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

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 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 :

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

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

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

         _____________________                                                   _______________________

             Location Head QA                                                                     Signature & Date

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