SOP on Handling of Deviations

pharmaguidances.com/handling-of-deviations-2

Objective :To describe a procedure for handling of deviations which may occur
during the execution of various activities in written procedures in facility.

Scope:This Standard Operating Procedure shall be applicable to all the departments

responsible for carrying activities related to the manufacture of the product, in the
formulation plant of (Pharmaceutical Company Name).

Responsibility
Personnel of concerned department shall be responsible to notify immediately
their respective superiors when any deviation occurs or is noticed.
Head-Regulatory Affairs or his/her designee shall be responsible for facilitating
prior notification or intimation to the regulatory authority, if the deviation has
impact on the concerned regulatory submissions.
Head of the concerned department or his/her designee, and Head-Quality
Assurance or his/her designee of respective location shall be responsible for
implementation and compliance of this SOP.

Accountability

4.1 QA Head shall be accountable for implementation of this SOP.

Abbreviations and Definitions

BMR:Batch manufacturing record; a controlled regulated copy, which comprises the

recordings against the manufacture of a batch.

PDR :Planned deviation report

UDR :Unplanned deviation report

cGMP:Current good manufacturing practices

BPR:Batch packing record

ICH:International conference on harmonization

Written Procedures :Written procedures are the approved and controlled documents which
are followed for the execution of various activities performed in the organization viz.,Batch
Manufacturing Records detailing manufacturing and packaging procedures, Standard
Operating Procedures (SOPs), Standard Testing Procedures (STPs). General Test
Procedures and various protocols followed for the execution of validation studies, stability
studies, etc.

Deviation : Any non-conformance /disobeyance in written approved procedures of quality

system in the organization.

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Or

We have any written procedure like standard operating procedure, standard test procedure,
BMR etc. and works against this, then it is called deviation. It means deviation from any
written procedure that we have implemented.

Critical Deviation: The deviation is likely to or will have a significant impact on critical
attributes of the product.

For example: Manufacturing instructions are not followed, wrong batch details are
printed, SOPs or methods of testing not followed during analysis etc.

Major Deviation : The deviation could or may have a significant impact on critical
attributes of the product.

For example: Raw material is received in a damaged container, manometer readings in

the sampling booth are crossed the action limits etc.

Minor Deviation:The deviation is unlikely to have a detectable impact on critical attributes

of the product.

For example: Line Clearance is not taken from QA, physician sample wrongly printed with
price, etc.

Critical Attribute :A critical attribute is one that defines the product and contributes to
safety, identity, purity, strength or quality. Critical attributes are usually detectable
during product testing.

Unplanned Deviation: An accidental or unanticipated non-conformance or deviation

observed or noticed during or after the execution of an activity. An unplanned deviation
can be a critical or major or minor in nature.

For example: deviation in failure of procedure, utility, material, equipment or any system is
occurred. We can consider it as any change from the previous or our written procedure.

Planned Deviation : Any deliberate or intentional non-conformance or deviation Planned

prior to the execution of an activity, which is to be undertaken following documented,
justifiable and approved rationale. No critical or major deviation, which has potential to alter
the quality of the product, shall be planned.

For example: Calibration or validation is not carried out as per schedule due to delay for
various reasons.

Procedure
Deviations may be classified into following two categories:
Planned Deviation
Un-planned Deviation

Unplanned & Planned deviations shall be sub classified on the basis of their impact of
product quality in critical, major or minor.

Planned Deviation (Planned Deviation Report)

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Any departure from established and approved procedures observed or noticed
prior to the execution of an activity, such as SOPs, STPs, processes, systems,
standards and protocols, which is done under compulsion or for continuous
quality improvement programs will be categorized as planned deviation.
No critical or major planned deviation shall be allowed, which has potential to
alter the quality of the product, only minor deviation shall allow to plan.
Such a planned deviation shall be taken / implemented only after proper
evaluation, risk assessment and pre-approval from Quality Assurance.
Such planned deviation shall be properly reported, assessed / evaluated for its
impact on product quality, process performance or GMPs.
Any personnel from concerned department shall initiate the “Planned Deviation
Format” by detailing the reason for deviation as per Annexure I.
The department head shall review the proposal of planned deviation,
justification given for its potential impact on the product quality and compliance
to regulatory requirements for necessity / feasibility of the deviation, by
providing supporting data.
After review by concerned Head of department, the proposal shall be
forwarded to Plant Head.
After review by Plant Head, the proposal shall be forwarded to QA for review
and approval.
QA shall assign a unique number to each planned deviation as follows:
The numbering system for a planned deviation shall consist of ten (10)
alphanumeric characters.
For example, PDR/16/001 shall be assigned to the first planned deviation of
year 2016.
In the above planned deviation report number, the 1st, 2nd & 3rd characters
‘PDR’ stand for ‘Planned Deviation Report’.
The 4th character “/” is a forward slash.
The 5th & 6th characters ‘16’ represent the last two digits of the year 2016.
The 7th character “/” is again a forward slash.
The 8th, 9th & 10th characters ‘001’ represent sequential number.
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.
Head QA shall assess the requirement for any additional testing or checks for
quality monitoring of the Planned Deviation and documents for the same.
QA shall consult Regulatory Affairs, where applicable, for any planned
deviation before providing approval. The RA may provide inputs as necessary
based on GMP and regulatory requirements.
Head QA shall approve / reject the Planned Deviation with appropriate
recommendations.
If approved, the deviation shall be applicable for a defined number of batch (es)
or defined number of days as mentioned in the Planned Deviation Report.
After QA approval, the concerned department shall implement the planned
deviation and the observations and data generated shall be documented.
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 QA shall review the implementation and documented data obtained from
respective departments to ensure that the recommendations are complying
with quality profile of the batch (es) impacted by the deviation. This data shall
support with the “Planned Deviation Report”.
The closure of planned deviation shall be the responsibility of the Department
Head and Head-QA.
If the deviation is related to the batch which is for sale, then the batch shall be
released only after QA approval and closure of deviation.
Recommendations may be conferred during the review.
If the planned deviation in the process / procedures leads to improvement in
the product quality / process / assurance / GMP, then the deviation / change
can be made permanent by following the change control procedure (SOP on
change control procedure).
In conclusion, Head of concerned department and Head QA shall close out the
deviation.
QA shall maintain a logbook for the approved planned deviations as per
Annexure III.

Unplanned Deviation (Unplanned Deviation Report)

While carrying out day-to-day activities, there is a probability of unplanned
deviations (unforeseen deviations) occurring. Such unexpected events may be
related to any procedures, processes, systems, equipment and utilities. These
deviations may occur for many reasons, such as following (not all inclusive):
Equipment failure / Breakdown / Malfunctioning.
Power supply failure / interruption.
Accident in the plant.
Breakdown in support services / utilities.
Documentation Errors
Laboratory failure / Error.
An unplanned deviation report (UDR) shall be initiated as a part of the approved
system for handling of deviations, in order to provide a mechanism for ensuring the
recording of the deviation and assess the impact on product quality. If required,
corrective and preventive action shall be performed to ensure product quality.
User department shall make request for issuance of unplanned deviation Format to
Quality Assurance department through Issuance from.
Any individual on the job shall inform concerned department supervisor regarding the
occurrence of deviation and details of initial observations.
The concerned department personnel shall fill the details of the unplanned deviation
along with cause and investigation details as per Annexure II and forward the same
to department head for review, assessment and comments.
While review, concerned head of the department shall incorporate corrective and
preventive action based on assessment. Then the ‘Unplanned Deviation Report’ shall
be forwarded to Plant Head for review.
Then ‘Unplanned Deviation Report’shall be submitted to the QA for review and
approval.
QA shall assign a unique number to each unplanned deviation report as follows;

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 The reference number for an unplanned deviation report shall consist of ten (10)
alphanumeric characters.
For example, UDR/16/001 shall be assigned to the first unplanned deviation of year
2016.
In the above unplanned deviation report number, the 1st, 2nd & 3rd characters ‘UDR’
stands for ‘Unplanned Deviation Report’.
The 4th character “/” is a forward slash.
The 5th & 6th characters ‘16’ represent the last two digits of the year 2016.
The 7th character “/” is again a forward slash.
The 8th, 9th & 10th characters ‘001’ are a sequential number.
QA shall maintain a logbook for the unplanned deviations as per Annexure III.
The filled form shall be forwarded to QA head after review by QA.
Head – QA & Head – concerned department shall assess unplanned deviation
for its impact on product quality. Details shall be documented as per Annexure
II.
Head QA may recommend for performing any additional studies, if required.
If the deviation does not affect product quality, Head – QA shall allow further
processing of the batch in question.
If there is probability of product quality getting affected, Head – QA shall assess
the impact on product quality before allowing further processing of the batch.
Product may be “Quarantined” in sealed containers, if required. Containers
shall be labeled, indicating product name, Batch No., Manufacturing Date,
Expiry Date & Batch size. The labeled containers shall be kept in secured
quarantine area.
Head – QA along with the Head of concerned department shall investigate &
find out the root cause of the problem that resulted in the deviation as per SOP
on CAPA.
Based on the investigation, the proposed corrective and preventive action shall
be taken to avoid any such reoccurrence and the same shall be implemented.
If required Formulation Research & Development (FR&D) shall be consulted by
QA to review impact on product quality and decide upon the future course of
action(s).

Closure of Deviation
In conclusion, Head – QA shall close the deviation by reviewing and assessing the
impact of deviation on the quality of the product.
Any supporting data and comments required to close the deviation (e.g.stability data)
shall be recorded or attached to the deviation report.
The time line for closure of deviation (planned or un-planned) shall be not more than
30 working days. If required, extension should be taken.
Both planned and unplanned approved deviations shall be controlled by QA and the
same shall be documented in the respective BMR also.

(Note: The planned deviation shall be implemented after the approval of QA).

Forms and Records (Annexures)

Planned Deviation Report – Annexure-I
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 Unplanned Deviation Report – Annexure-II
Logbook for Planned/Unplanned Deviation Reports – Annexure-III

Distribution
Master Copy- Quality Assurance
Controlled Copies -Engineering, Human Resource, Production, Quality
Assurance, Quality Control, Regulatory Affairs, Warehouse
History

Date Revision Number Reason for Revision

– 00 New SOP

Annexure – I

Planned Deviation Report

1.0 Review by Department Head (Comments):

Reviewed by Name Signature Date

2.0 Review by Plant Head (Comments):

Reviewed by Name Signature Date

QA Review / Approval
Comments received from QP attached: Yes /No / NA
Any additional studies required: Yes / No
Stability Studies, Additional Quality Testing,Others

___________________________________________________________________________

QA Comments:

___________________________________________________________________________

Deviation: Approved Rejected

The Planned Deviation is limited to time / No. of Batches: _________________

Review by Head – QA Name Signature Date

Implementation of Deviation
Deviation implemented by (department)
:_______________________________
Observations (If any):______________________________________________

Data Generated (If any):

_________________________________________________

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 Quality Profile of batches affected (If applicable):
_____________________________

Implemented By Name Signature Date

Department Head

QA Review of Implementation & Closure

QA comments:
____________________________________________________

All recommendations fulfilled: Yes /No

If No, Justification:
______________________________________________________

Data generation completed: Yes / No

If No, Justification:
______________________________________________________

Can the Deviation/Change be made permanent through change control? Yes/ No

Remarks (If any):
_______________________________________________________

Affected batch can be released? Yes/No

Closure Approved By Department Head / Nominee Name Signature Date

Closure Approved By Head-QA/ Nominee

Annexure – II

Unplanned Deviation Report

Date
_______

Deviation Initiation

1.1 Unplanned Deviation ________________ (to be assigned by QA)

Report No.:

1.2 Deviation Reported

By
(Department):

1.3 Product Name: Batch No.: _________ Market: ___________

___________

1.4 Batch Size: Mfg. Date: _________ Expiry Date: _______

______________

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 1.5 Deviation related to: Procedure Process Equipment Standard
Batch Size
Others( If any) specify:

1.6 Potential Impact On Quality Yield GMPs Manufacturing

Process Others ( If any) specify :

1.7 Deviation Details:

1.8 Cause for Déviation

1.9 Investigation Details:

1.10 Proposed Corrective

Action

1.11 Proposed
Preventive Action

Initiated Name Signature Date

By

2.0 Review by Department Head (Comments):

Reviewed by Name Signature Date

3.0 Review by Plant Head (Comments):

Reviewed by Plant Head Name Signature Date

4.0 QA Review for implementation of CAPA (Comments):_____________

Details of any additional studies Required / Performed:

Reviewed by QA Name Signature Date

5.0 Review & Deviation Closure by Head – QA (Comments):

Reviewed by Name Signature Date

Head-QA

Annexure -III

Log Book for Planned/Unplanned Deviation Reports

Sr. Date PDR/UDR Deviation Initiated Expected date Approved Closed Remarks
No. No. Related By for / out on
to & Deptt. Implementation Rejected (sign/date)

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