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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 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.
...........................................................................................................................................
...........................................................................................................................................
___________________ _________________________
10. Decision by Q.A.M
Approved Non Approved
Remarks:-...............................................................................................................................
........................................................................................................................................
_________________ _______________________
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 pharmaguideline.com, a widely-read pharmaceutical blog since 2008.
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SOP for Deviation Control

pharmaceutical manufacturing facilities.

Ankur Choudhary  Print  Question Forum  No comments

To lays down a procedure for change control.

covering the manufacturing, packaging and in-process activities.

categorized as either minor or major deviation.

only so that the batch may be completed.

changes should be recorded/regularized / and authorized by the Technical Director.

5.7 The change should be validated for three consecutive batches.

the ﬁle for further reference.

5.10.1 Procedure for Raising deviation Report.

In the approved format (Annexure 1) with justiﬁcation for deviations.

validation. Stability study for change control required or not.

6.1 SOP: Standard Operating Procedure

6.2 QA: Quality Assurance

1. Deviation Report Number ....................................

Product Batch No. Market. Pack Size. Mfg.Date Exp.Date

Planned Unplanned

(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

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

_________________ _______________________

Name Signature & Date

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

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

_____________________ _______________________

Location Head QA Signature & Date

 Get ready to use editable documents in MS-Word Format View List

Ankur Choudhary is India's ﬁrst professional pharmaceutical blogger, author and

founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008.

◉ Offline Need Help: Ask Question

« SOP for Reprocessing and Reworking SOP for Review of BMR »

Maintenance Calibration Warning Letters Education B.Pharmacy

CURRENT JOBS Post Job for

Walk-in for Indoco Remedies Limited on 26/03/2023

QC Executive in Casper Pharmaceuticals

Ofﬁcer QA in Marksans Pharma Ltd

Production Chemist in Sarv Bio Labs Pvt. Ltd.,

RESEARCH ASSOCIATE in Sarv Bio Labs pvt. Ltd.,

Executive/ Sr. Executive QA in Hetero Labs Limited

Walk-in for Alkem Laboratories Ltd. on 19/03/2023

Walk-in for BE Pharmaceuticals on 12/03/2023

Walk-in for MSN Laboratories on 07/03/2023

Research Associate / Senior Research Associate in Gracure Pharma

Enter your email Join

GET APP FOR NEWS UPDATES

✔ Worldwide Regulatory Updates

GMP Violations at Indian Facilities

GMP Requirements in Pharmaceuticals

Writing Effective SOPs in Pharmaceuticals

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Preparing for FDA Inspections: Best Practices for Compliance

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