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Title: Handling of Deviation SOP. No. : SPL/ SOP/QA/010

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1. Objective
To define the procedure for handling of deviations

2. Scope
This procedure is applicable to all departments involved in GMP at Solitaire Pharmacia Pvt.
Ltd., Baddi

3. Responsibility
Operating Manager for initiation, investigation, execution and evaluation of deviation in
respect to its impact on product quality

Sr. Head- QA for approval and recommendations

4. Accountability
Sr. Head- QA/ Department - Head

5. Procedure

5.1 Deviations may be classified into following two categories;

 Planned Deviation
 Unplanned Deviation (unforeseen deviations, non – conformances)
5.2 Planned Deviations (Planned Deviation Report)
5.2.1 Any Deviation in manufacturing process / procedure / testing procedure / operating /
calibrating procedure, batch size, equipment, operating environment or any other GMP critical
process which is pre-planned for the forthcoming batches, shall be known as planned
deviation.
5.2.2 Such a pre-planned deviation shall be taken / implemented only after pre-approval from HEAD
QA
5.2.3 Such planned deviations shall be properly documented, assessed / evaluated for its impact on
product quality and authorized by HEAD QA in advance.
5.2.4 All planned deviations shall be recorded as per format No. SPL/QA/020.
5.2.5 QA shall maintain a logbook for the approved planned deviations as per format No.
SPL/QA/021
5.2.6 The concerned department shall initiate the Planned Deviation as per format No. SPL/QA/020
and sign.
5.2.7 The department Sr. Head and plant Head shall review the proposal for planned deviation,
Format No.SPL/ QA/001
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justification given for its potential impact on the product quality and compliance to regulatory
requirements, for necessity / feasibility of the deviation and sign in the specified columns.
5.2.8 QA shall assign a unique number to each planned deviation as follows;
5.2.8.1 The report number for a planned deviation shall consist of ten (10) alphanumeric characters.
5.2.8.2 For example, PDR/14/001 shall be assigned to the first planned deviation of year 2014.
5.2.8.3 In the report number for planned deviation, the 1st, 2nd & 3rd characters ‘PDR’ stand for
‘Planned Deviation Report’.
5.2.8.4 The 4th character “/” is a forward slash.
5.2.8.5 The 5th & 6th characters ‘14’ represent the last two digits of the year 2014.
5.2.8.6 The 7th character “/” is again a forward slash.
5.2.8.7 The 8th, 9th & 10th characters ‘001’ are a sequential serial number.
5.2.9 Sr. Head QA shall review the planned deviation with respect to impact on product quality,
necessity / feasibility of the deviation proposed, rationale / justification & compliance to
cGMP / regulatory requirements, along with the adequacy of the supporting data attached.
5.2.10 Sr. Head QA shall assess/ recommend the need for any additional testing or document for
quality monitoring of the Planned Deviation batches.
5.2.11 Sr. Head QA shall approve / reject the Planned Deviation with appropriate recommendations.
5.2.12 If approved, the deviation shall be applicable for a defined number of batches or defined
number of days, as mentioned in the Planned Deviation Report.
5.2.13 After Head QA approval, the concerned department shall implement the planned deviation and
the observations and data generated shall be documented.
5.2.14 Head QA shall review the implementation and make sure that the recommendations are
complied with quality profile of the batch (es) impacted by the deviation is (are) studied and
all the data is annexed with the “Planned Deviation Report Format” SPL/QA/020.
5.2.15 If the planned leads to improvement in the product quality / process / GMP, then the deviation /
change can be made permanent by change control procedure.
5.2.16 Finally, Plant Head and QA Sr. Head shall sign and close the deviation.

5.3 Unplanned Deviations (Unplanned Deviation Report)

5.3.1 While carrying out day-to-day activities, there are chances of unplanned deviations (unforeseen
deviations) and events to occur. These deviations are unforeseen, accidental and may be due to
several reasons like;
 Equipment failures / breakdowns / malfunctioning / Process Failures.
 Power supply failures / interruptions.
 Accident / Mishap in the plant.
Format No.SPL/ QA/001
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 Breakdown in support services / utilities.

 Documentation Failures.
 Analytical Failures / errors.
 Any other unforeseen situation.

5.3.2 An unplanned deviation report (UDR) shall be raised as a part of the approved system for
handling of deviations at the time they occur, in order to provide a mechanism for alerting
production and quality department to record the deviation and assess the impact and perform
corrective action.

5.3.3 All unplanned deviations shall be recorded as per format No. SPL/QA/022

5.3.4 Head QA shall maintain a logbook of the approved unplanned deviations as per format No.
SPL/QA/023.

5.3.5 Operator on the job shall inform production supervisor about the details of incident, resulting
in deviation in the process.

5.3.6 Concern officer / executive shall fill the details of the unplanned deviation in format No. SPL/
QA/022 and forward the same to department Sr. Head for his review, assessment and
comments.

5.3.7 Finally, the ‘Unplanned Deviation Report’ shall come to Head QA for review and approval.

5.3.8 Head QA shall issue the deviation report number as given;

5.3.8.1 The reference number for an unplanned deviation report shall consist of ten (10) alphanumeric
characters.

5.3.8.2 For example, UDR/14/001 shall be assigned to the first unplanned deviation of year 2014.

5.3.8.3 In the report number for unplanned deviation, the 1st, 2nd & 3rd characters ‘UDR’ stands for
‘Unplanned Deviation Report’.

5.3.8.4 The 4th character “/” is a forward slash.

5.3.8.5 The 5th & 6th characters ‘14’ represent the last two digits of the year 2014.

5.3.8.6 The 7th character “/” is again a forward slash.

5.3.8.7 The 8th, 9th & 10th characters ‘001’ are a sequential serial number.

5.3.9 Sr. Head - QA shall assess unplanned deviation for its impact on product quality.
Format No.SPL/ QA/001
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5.3.10 Sr. Head QA may recommend for performing any additional studies, if required.

5.3.11 If the Deviation does not affect product quality, Sr. Head QA shall allow further processing of
the batch in question.

5.3.12 If there are likely chances of product quality getting affected, Sr. Head QA shall assess the
impact on product quality before allowing further processing of the batch.

5.3.13 Product may be kept in Quarantine in sealed containers, if required. Containers shall be
labeled, indicating product name, Batch No., Manufacturing Date, Expiry Date & Batch size.

5.3.14 Sr. Head QA along with the Head - Production & Head - Maintenance shall investigate & find
out the root cause of unplanned deviation.

5.3.15 Based on the investigation, corrective and preventive action shall be implemented to avoid any
such reoccurrence.

5.3.16 If required, Research & Development (R&D) shall be consulted by Head QA to review impact
on product quality and decide upon the future course of action(s), which could be:
 Reprocessing or
 Rejection of batch.

5.3.17 Based on R&D advise Head QA shall inform to plant Sr. Head / Head Production for reprocess
or rejection

5.3.18 Reprocessed batch shall be kept on stability studies as per ICH Guidelines, in case of major
rework.

5.3.19 Reprocessed product shall be released only if the Product meets all the approved specifications.

5.3.20 QA Executive shall review stability data at scheduled intervals to decide further course of
action.

5.3.21 Finally, Sr. Head QA shall close the deviation by reviewing and assessing the impact of
deviation on the quality of the product.

5.3.22 Both planned and unplanned approved deviations shall be controlled by QA and the same shall
be documented in the respective BMR also.

5.3.23 Any data, comments, documents required to close the deviation (e.g. stability data) shall be
recorded or attached to the deviation report.

Format No.SPL/ QA/001

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Title: Handling of Deviation SOP. No. : SPL/ SOP/QA/010

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5. Records/Formats:
SPL/QA/020 - Planned Deviation Report
SPL/QA/021 - Planned Deviation Logbook
SPL/QA/022 - Unplanned Deviation Report
SPL/QA/023 - Unplanned Deviation Logbook

7. Annexure:
Annexure-1 - Flowchart of unplanned deviation Attached
Annexure-2 - Flowchart of planned deviation Attached

8. Reference:
ICH Q7, APIC

9. Abbreviations:
SOP - Standard Operating Procedure
SPL - Solitaire Pharmacia Pvt. Ltd., Baddi
QA - Quality Assurance
ICH - International Conference on Harmonization
BMR - Batch Manufacturing Record
CAPA - Corrective & Preventive action
PDR - Planned Deviation Report
UDR - Unplanned Deviation Report

10. Revision History:

Revision No. Effective Date Reason for Revision

00 New Document

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Title: Handling Of Deviation

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Planned Deviation Report
Format No. SPL/QA/020 Date: ___________
1.0 Deviation Initiation

Planned Deviation Report

1.1 (to be assigned by QA)
No.:
1.2 Initiated By (department):

Product/ Equipment Batch/ Equipment Market:

1.3
Name: ___________ No.: _________

1.4 Batch Size: Mfg. Date: Expiry Date:

Procedure, Process, Equipment

Deviation
1.5
related to:
Standard, Batch Size Others

Quality, Yield, GMPs

Potential
1.6
Impact On
Manufacturing Process, Others

Deviation
1.7
Details:

Justification
1.8
/ Rationale:

Attachments
/ Supporting
1.9
Data (If
any):

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Title: Handling Of Deviation

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Name Signature Date
Initiated By

Review by
Department
2.0 Head
(Comments):
Review by Name Signature Date
Department
Head

Review by

3.0 Plant Sr.

Head
(Comments):
Name Signature Date
Review by
Plant Head

4.0 QA Review / Approval

4.1 Any additional studies required: Yes / No
4.1.1 Stability Studies, Additional Quality Testing, Others
4.2 Quality Assurance (comments): _____________________________________________________
_______________________________________________________________________________
4.3 Deviation: Approved Rejected
4.4 The Planned Deviation is limited to time / No. of Batches: _________________________
Name Signature Date
Review by QA

5.0 Implementation of Deviation

5.1 Deviation implemented by (department) : ______________________________________________
5.2 Observations (If any): _____________________________________________________________

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5.3 Data Generated (If any): ___________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
5.4 Quality Profile of batches affected (If applicable): _______________________________________
_______________________________________________________________________________
Name Signature Date
Implemented By
Department Head

6.0 QA Review of Implementation & Closure

6.1 Head QA comments:
___________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
6.1.1 All recommendations fulfilled: Yes / No
6.1.2 If No, Justification: _________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
6.1.3 Data generation completed: Yes / No
6.1.4 If No, Justification: _______________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
6.1.5 Can the Deviation/Change be made permanent through change control? Yes/ No
6.1.6 Remarks (If any): _________________________________________________________________
Closure Approved By Name Signature Date
Operating Manager /
Nominee
Closure Approved By
QA Manager / Sr. Head-
QA

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Log Book for Planned Deviation Reports
Format No. SPL/QA/021

Approved/ Closure
S. Deviation Deviation Probable Date Deviation
PDR Originating Rejected of
Date Related Initiated of Approved/
No. No. Department By Deviation
To By Implementation Rejected
(sign&date) On (date)

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Unplanned Deviation Report

Format No. SPL/QA/022 Date _______
1.0 Deviation Initiation

1.1 Unplanned Deviation Report No.: (to be assigned by QA)

Deviation Reported By
1.2
(department):
Product/ Equipment Batch/ Equipment Market:
1.3
Name: ___________ No.: _________

1.4 Batch Size: Mfg. Date: Expiry Date:

Procedure, Process, Equipment

Deviation
1.5
related to:
Standard, Batch Size Others

Quality, Yield, GMPs

Potential
1.6
Impact On
Manufacturing Process, Others

Deviation
1.7
Details:

Cause for
1.8
Deviation

Investigation
1.9
Details:

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1.10 Corrective Action Taken:

Planned Preventive
1.11
Action

Name Signature Date

Initiated By

Review by Department
2.0
Head
(Comments):
Name Signature Date
Review by
Department
Head

Details of any additional

3.0
studies Required /

Performed

QA Review for

implementation of
3.1
CAPA

(Comments):
Name Signature Date
Review by

Officer /

Executive

QA

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Review by Plant Head

4.0
(Comments):

Name Signature Date

Review by

Plant Head

Review & Deviation

Closure by
5.0
Sr. Head - QA
(Comments):

Name Signature Date

Review by

QA/ Sr.

Head - QA

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Log Book for Unplanned Deviation Reports

Format No. SPL/QA/023

Deviation
Deviation Corrective Action
S. No. Date UDR No. Preventive Action Authorized
Related To Taken
By

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Flow Chart for Handling of Planned Deviations
Annexure-1

PLANNED DEVIATIONS

Justification

Document (Format No:

SPL/QA/020)

Assign Reference
Number

Assess Impact on
Product Quality

Review by HEAD
QA

Decision

Rejected Approved

Not Implemented Implemented

Documentation Documentation

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Flow Chart for Handling of Unplanned Deviations
Annexure-2

UNPLANNED DEVIATION

Document (Format No:

SPL/QA/022)

LOGIN INVESTIGATION

Assign Reference
Number
ROOT CAUSE

Assess Impact on Product

Quality

PREVENTIVE
ACTIONS
No Impact Impact on
Quality

Sr. Head- QA REVIEW BY HEAD

Sr. Head QA QA/ Manager
Review
Review

Allow Further
Processing

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Decision

Reject the Reprocessing

batch

Destroy as per Reprocessing

Procedure procedure from R
&D

Document
Document

Product
Conforms to
Specifications

Release Stability
Studies

Any
Abnormality

Review & Closure by Sr. Head -

QA

Format No.SPL/ QA/001