SUN MOON PHARMACEUTICALS PVT. LTD.

Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 1 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

1.0 OBJECTIVE:

To lay down the procedure for handling of deviations.

2.0 SCOPE:

This SOP shall be applicable to all the departments of all the facilities of the Sun Moon
Pharmaceuticals Pvt. Ltd.

3.0 RESPONSIBILITY:

Intimation /information & initiation: All chemists / supervisors / officers / executives to document
the deviations.
To provide justifications for deviation and investigate specifically the critical
deviations:Heads/designee of concerned departments.
To approve/authorize deviation on the basis of justification and data (wherever applicable) provided
by various heads.:Head of QA/ Designee.
To monitor the corrective action taken, to review the efficacy of the preventive action taken.
Ifany:QA/ Designee.

4.0 PRECAUTIONS:

NA

5.0 PROCEDURE:

5.1 Definition:

5.1.1 Deviation:
A deviation is defined as a departure from an approved instruction or established
standard.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 2 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

5.1.2 Unplanned Deviations

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.
 Breakdown in support services / utilities.
 Documentation Failures.
 Analytical Failures / errors.
 Any other unforeseen situation.

5.1.3 Critical Deviation: “A critical deviation is defined as a variation to previously

establish critical parameters or a significant variation to standard operation, which
could affect the quality of the product or in process product. Critical deviations
should always be investigated and corrective actions identified.”

5.1.4 Non Critical Deviation: “Deviation that occurs apart from established critical
parameters or a significant variation to standard operation which could affect the
quality of product safty process product are non-critical deviations .These non-critical
deviations may not have any impact on the quality of the product.” If deviation
occurs, they should be approved in writing by QA, consequently the deviation can
occur in any department while implementing any procedure or system.

5.1.5 Immediate Corrective Action

The very first action to be taken is stop the activity immediately and avoid further
impact of the deviation on the concerned observation.

5.2 Intimation or information of deviation

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 3 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

5.2.1 If any deviation occur or observe by user the same shall be inform to
Supervisor/senior or department head without any delay.

5.2.2 User department shall also communicate regarding deviation with QA department.

5.3 Assigning of deviation control number

5.3.1 User department shall give requisition for deviation control form with reason of state.

5.3.2 QA shall issue deviation form to the user department with assigning of deviation
number.
Note: QA can issue deviation form (Blank) without assigning deviation number to
production and Quality control department in advance if in case deviation found or
occur during shift the same shall be documented by concern user personnel after
communicate with his senior/management.

5.3.3 Deviation form number is assigned as:

DV/XX/YYY/ZZ
Where,
DV - Abbreviation for Deviation.
XX - Two digits Department Code.
YYY – Three digits Serial No. of deviation in a calendar year.
ZZ – Last two digits of the calendar year.

For example:DV/PD/001/20 indicates first deviation of production department during the

year 2020.

5.3.4 Same deviation shall be logged in a deviation control log as per Annexure –2.

5.4 Categorization of deviation:

5.4.1 User shall categorize the deviation in a process or in a non-process deviation.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 4 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

5.5 Process Deviations:

5.5.1 The process deviations could be critical and non-critical deviations

5.5.2 Process deviation may arise due to:

 Human
 Equipment not functioning properly or equipment out of calibration.
 Breakdown of the equipment / utilities.
 And at times may lead to non-conforming product.

5.5.3 Some Examples of critical process deviations are:

 Temperature, pressure, vacuum parameters outside defined limits in during

process.
 Operating instructions not correctly followed in during process.
 Breakdown of process equipment or failure of utilities in during process.
 Production records not adequately completed in during process.
 In Process Control Limits not achieved in during process.
 Extraneous contamination of product and intermediates in during process.

5.5.4 Handling of critical deviations in the process:

5.5.4.1 In case the deviation is critical, the functional head reports the deviation
tothe Head QA in the deviation form as per Annexure-1. If the deviation
requires emergency/immediate action like in plant process, the functional
head or his deputy can take emergency/immediate corrective action &
then report to Head-QA at the earliest.

5.5.4.2 The functional head in consultation with Head-QA investigate the cause of
deviation and impact on quality of the product, safety or the operation
andalso check impact on the other department system.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 5 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

5.5.5 Handling of An unplanneddeviation:

An unplanned deviation report 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.

5.5.6 Handling of non-critical deviations

5.5.6.1 All non-critical deviations should be reported to QA at the earliest.

5.5.6.2 QA monitors the trend of non-critical deviations and initiate appropriate

actions to minimize the same.

5.5.7 Some : Examples of non-process deviations are

 Delay in carrying out the calibration of equipment

 Non adherence to the stability schedule
 Breakdown of process equipment or failure of utilities
 Equipment out of calibration
 Test records not adequately completed

5.6 Deviation form handling: Particulatesshall be filled in the deviation form as per following.

5.6.1 The procedure for carryout deviation control form for process and non-process
deviations as per below.

5.6.2 The Deviation Control form request could be initiated by the respective user
department.

5.6.3 Deviation control form shall be issued by QA personnel with allocation of reference
deviation number, department and sign with date.
5.6.4 Fill the deviation form as per Annexure –I.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 6 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

5.6.5 Concerned department with QA person and with other department’s qualified
personnel (if required) shall also carry out investigation in to root cause for the
deviation also record whether the deviation occurred for the first time or earlier also
the same deviation was observed.

5.6.6 If same type of deviation observed earlier so find out the root cause and CAPA
reference shall be mentioned.

5.6.7 Specify the corrective actions, if warranted, proposed or taken.

5.6.8 Remedial/corrective action shall be mention properly with respect to cover all
parameter.

5.6.9 Concerneddepartment/QA/Management shall also specify the preventive actions

proposed.

5.6.10 Training shall be imparted if necessary and same shall verified by QA.

5.6.11 The form duly signed by initiator and HOD along with attachments, if any, shall be
forwarded to QA.

5.6.12 User department/initiator shall return deviation form with above specified
information/details within 2 working days after issuance of deviation form. ( In case
of critical deviation remedial action shall be reviewed immediately by QA)

5.6.13 QA shall review the deviation for its justification investigation report, give the
comment for the same and ensure that the investigation has been carried out properly.

5.6.14 QA shall review the corrective action taken and give comment for action to be taken.

5.6.15 Assess whether deviation impact on product quality – purity, impurity profile,
physical characteristics and stability.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 7 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

5.6.16 In case the deviation is in critical process parameters or other activity which have a
potential impact on quality of the product, sufficient preceding and succeeding
batches shall be reviewed.

5.6.17 QA shall examine the adequacy of the corrective action proposed and if necessary
will consult the concerned departmental head or other related departments.

5.6.18 QA shall examine the need to include the quality impacted batches in the stability
program or to carry out the concurrent validation.

5.6.19 QA shall examine whether the deviation is occurring frequently. In case it is

occurring frequently, then process shall be reviewed.

5.6.20 In case the deviation results in breakdown of an equipment/instrument, the

equipment/instrument should be rectified to previously defined ‘specifications’ and
‘performance’ before going to routine use.

5.7 If the deviation has been observed for the first time:

5.7.1 QA will forward the Deviation Approval Form to R & D who will check:

5.7.1.1 Whether the product / material can be used under deviation without an
adverse effect on the Quality of the product.

5.7.1.2 Whether the usage of the material require any additional washings / step /
reagent / solvent.\
NOTE: The additional washings may be permitted.

5.7.1.3 Whether any Lab Performance studies are required If so, what type of
studies and the analytical support.

5.7.2 R&D will carry out the required studies / Lab Performance.

5.7.3 QC will provide analytical support or tests and will carry out the development of the
Test Procedure if required.
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 8 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

5.7.4 R & D will complete the required information and give its comments on the form and
if required the processing steps.

5.7.5 Based on the results, R&D will recommend or disapprove the use of the Product /
Material under deviation and send the form to QA.

5.7.6 Head-QA will finally Approve or Disapprove the use of the Product / Material under
deviation.

5.7.7 After approval / Disapproval QA will take three copies of the Deviation Approval
Form and send a copy to Production, R & D and QC for their records and further
action.

5.7.8 QC will change the Status of the material / product as ‘Approved under Deviation’
and / or send ‘Approved under Deviation’.

5.7.9 In case any problem is observed or the quality is not as expected, it will immediately
bring to the notice of Head-QA and further usage of the Product / Material under
deviation will be stopped and batch(es) manufactured will be cordoned off and held
‘under Quarantine’.

5.7.10 QA will carry out Investigation in to OOS results as per the SOP for Out Of
Specification.

5.7.11 Based on the R & D recommendations action shall be taken as per the following

5.7.12 These batch(es) shall be reprocessed / disposed off as per the procedure for the
‘Reprocessing or Disposal of Non- conforming products’.

5.7.13 These batch(es) shall be taken for further processing under deviation. For this
purpose the Deviation Approval Procedure will be followed once again.
Reprocessed / Disposed off as per the procedure for the ‘Reprocessing or Disposal of
Non- conforming products’

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 9 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

5.7.14 Further usage of the material / product under deviation shall be carried out or the
Material / Product will be disposed off.

5.7.15 In case the Batch is to be included in the Stability Programme (as per the
recommendations of R&D or HOD (QA), QA will coordinate with QC and mention
the relevant details on the Deviation Approval Form.

5.7.16 Since it is not related to any quality, it is always a minor deviation only.

5.8 Deviations related to Quality Control instruments:

5.8.1 Whenever QC instruments break down, it shall be recorded in the Deviation control
form.

5.8.2 For which instrument deviation happened should be mentioned.

5.8.3 Description of Deviation should be mentioned.

5.8.4 Corrective and preventive actions shall be given by Head QC.

5.8.5 Head-QA will review the deviation and approve the deviation with remarks.

5.8.6 All the deviations must be recorded in the Deviation Control Record.

5.8.7 Any alternate test can be carried out during the break down of the instrument, if
possible, to check the quality of the product.

5.9 Reporting and Logging.

5.9.1 Deviation approval is a specific one time approval, granted for the product, drug
substance and intermediate item, document or equipment under discussion.

5.9.2 Any unplanned deviation should be reported within 24 hours by Department Head
and Quality Assurance.
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 10 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

5.9.3 Before being proposed, a planned deviation should be evaluated for impact
assessment.

Note: Repetitive planned deviation related to formula, process and process control
parameters for registered should be permitted only after prior approval from
concerned authority.

5.9.4 The individual notifying the deviation should fill the details of the deviation in
respective section.

5.9.5 Filled Deviation form should be handed over to the Notifying Department Head and
QA for the detailed investigation.

5.10 Impact, Assessment and Investigation:

5.10.1 Notifying Department Manager along with Quality Assurance should review the
details filled in by the person notifying the deviation and if required, ask for more
details.

5.10.2 The Notifying Department manager and Quality Assurance should investigate the
deviation and write the details in the remaining part of the ‘Reason / investigation
with document reference’ section.

5.10.3 Investigation should be done according to the sequence of events taken place and
should clearly state the stepwise course of events that led to the deviation.

5.10.4 Study should be done to assess the effect of the deviation on identity, quality, purity,
quantity, stability, safety, physical characteristics, and efficacy of the product, process
or process equipment and impact on other batches / products / items/ process
Equipments of the same product and is recorded in the ‘Impact of deviation on same
and other batches/ Products/ items/ process/ process equipment’ section.

5.10.5 Based on the investigation and impact assessment,Quality Assurance should

categorized the deviation as major or minor.
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 11 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

5.10.6 Wherever the investigation for a major deviation reveals more than one probable
cause, root cause analysis should be carried out, by notifying Department Head, as
applicable.

5.10.7 If a batch/ batches are affected, impact of deviation should be assessed on product
quality before releasing batch/ batches to the market. (Stability should be monitored,
if required). This decision should be made by the Site Quality Assurance and recorded
in the final review of the deviation.

5.11 Recommendation for CAPA Action

5.11.1 Notifying Department Head should initiate immediate action whether to ‘Stop
Activity’ or ‘continue activity’.

5.11.2 Notifying Department Head and Quality Assurance should suggest any additional
immediate action, whenever required, any additional immediate action should be
described along with a justification.

5.11.3 After receipt of comments from other Department Heads, the Notifying Department
Head, along with Quality Assurance and other Department Heads (for impacted
departments) should evaluate need and recommend the areas of corrective and
preventive action along with the assessment of the impact of corrective and
preventive action as per SOP CAPA. When the evaluation concludes that corrective
and preventive actions are not required, the same should be recorded in the Deviation
approval form.

5.11.4 The notifying Department Head should propose corrective and preventive action as
per CAPA SOP after logging the deviation in the CAPA log. The reference CAPA
number should be recorded in the deviation approval form.

5.12 Approval/ Disapproval of deviation:

5.12.1 The deviation approval form and recommended CAPA and its impact assessment
should be reviewed for adequacy by Quality Assurance and Unit Head. If any more
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 12 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

actions are recommended, the same should be updated in the recommended CAPA
and impact assessment and the approval or disapproval of deviation.

5.12.2 Wherever applicable, approval from R&D and Packaging development should be
taken and recorded in the ‘Approval/ Disapproval’ section of thedeviation approval
form. The applicability of these approvals should be decided by the Quality
Assurance.

5.12.3 Comment and approval should be taken from regulatory affairs, if required for
registered / to be registered products.

5.12.4 Any major deviation, in products meant for regulated market, or any deviation which
requires customer approval should be communicated to Regulatory Affairs.
Regulatory Affairs should decide on need of customer approval. Regulatory Affairs
should further communicate the deviation to the customer.

5.12.5 The Customer will evaluate the deviation and after studying the impact and report
back to Regulatory. Based on comments received from Customer, Regulatory Affairs
should record their comments on Annexure -1.

5.12.6 All data related to the deviation should be attached to the deviation approval form. All
the communications related to the deviation attached to the deviation approval form
and recorded in the Attachments section of Deviation approval form.

5.12.7 During any stage of approval if changes or additional requirements are suggested by
any of the approving authority, the notifying department has to carry out the up-dation
in the relevant sections of the Deviation approval form.

5.12.8 If any planned deviation is disapproved, it should be termed as ‘Closed and

Cancelled’ and same should be updated in the remarks column in the Deviation log.

5.13 Implementation of Immediate Corrective Action, Corrective Action, Preventive action

and closeout of deviation:

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 13 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

5.13.1 The additional immediate action should be implemented by the notifying department
after approval of the deviation.

5.13.2 The Unit Quality Assurance should coordinate and evaluate the implementation of
immediate action and decide for the closeout of the deviation.

5.13.3 The deviation should be closed based on immediate action and root cause
identification while the corrective and preventive actions may or may not remain
open.

5.13.4 In critical Deviation– after complete evaluation the immediate Corrective Action
should be taken within 03 days, and all further process of particular product may
remain stopped till the action is taken.

5.13.5 Major deviations should be investigated and closed for Corrective Actions in 15 days
and for minor deviations, should be close out in 30 days. Any deviation closeout
exceeding the mentioned period should be recorded as extended in the remarks
section of the deviation log and should undergo a review process.

5.13.6 All Preventive Action should be closed within defined time line, any deviation
closeout exceeding the mentioned period should be recorded as extended in the
remarks section of the deviation log and should undergo a review process.

5.13.7 Any deviation investigation leading to recall of product / batches should undergo
recall procedure as per Recall SOP.

5.13.8 After completion of Preventive Action close out date should be entered on the
deviation approval form by Quality Assurance with signature after final review of the
deviation. This closeout date should be recorded in the deviation approval form and in
the deviation log.

5.13.9 Close out of deviation should not extend more than six months and the deviation
should be termed as ‘Closed’ with an assessment and justification in the ‘final review’
section and same should be updated in the remarks column in the Deviation log.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 14 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

5.14 Review and Trending:

5.14.1 The deviation related to batches should be reviewed before the release and should be
recorded in the batch release documentation.

5.14.2 Log of the Deviation should be reviewed periodically for accuracy, completeness of
data, close out of deviations and close out of CAPA by Quality Assurance.

5.14.3 A review of all major / minor product related deviations should be done during the
Annual Product Quality Review.

5.15 Documentation:

5.15.1 The original copy of the deviation approval form and the deviation log should be
maintained by Quality Assurance Department.

5.15.2 Supporting data for deviation, investigation and corrective and preventive actions
should be attached to the deviation approval form.

5.15.3 A photocopy of the deviations occurred related to product / batch should be kept
along with the respective batch document after completion of investigation and
immediate corrective action.

5.15.4 After completion and implementation of relevant CAPA a copy of completed

Deviation Approval Form should be kept in the Batch Document and the earlier copy
of the Deviation Approval Form on which CAPA completion status is not specified
which is attached to batch record at the time of batch release should be removed and
destroyed by Quality Assurance.

5.15.5 Whenever a deviation is observed at any stage of manufacturing, packing or testing

the deviation number should be recorded in the batch record at each particular stage
as a remark by Quality Assurance.

5.15.6 Deviation records should be maintained for a period as per Archiving SOP.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF DEVIATION
Department : Quality Assurance SOP No. : SOP/QA/004
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 15 of 16
Prepared By Reviewed By Approved By
Sign. with
Date.

6.0 LIST OF ANNEXURES / ATTACHMENTS:

ANNEXURE – 1 Deviation Handling Form SOP/QA/004-F01.00
ANNEXURE – 2 Deviation Log Book SOP/QA/004-F02.00

7.0 ABBREVIATIONS:

No. Number
NA Not Applicable
REV. Revision
R&D Research and Development
Lab Laboratory
RA Regulatory Affairs
HOD Head of department
ICH International Conference on Harmonization

8.0 REFERENCE:

8.1 ICH Q7

9.0 SOP DISTRIBUTION:

Name of Department Department Code

Quality Assurance QA
Production PD
Quality Control QC
Microbiology MB
Maintenance & Engineering MD
Human resources HR
Warehouse WH
Research & Development RD

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