SOP on Handling of Deviations

 Pharmaceutical Guidanace  April 2, 2016  QA & QC, Quality Assurance

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SOP on Handling of Deviations

Objective:

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

Scope:

This Standard Operating Procedure shall be applicable to all the departments responsible for
carrying out activities related to the manufacture of the product, in the formulation plant of
(Pharmaceutical Company Name).

Responsibility

Personnel of the 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

noti cation 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

QA Head shall be accountable for the implementation of this SOP

Abbreviations and De nitions

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:

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 Written procedures are the approved and controlled documents that 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), and
Standard Testing Procedures (STPs). General Test Procedures and various protocols followed
for the execution of validation studies, stability studies, etc.

Deviation:

Any non-conformance /disobedience in written approved procedures of quality system in the

organization.

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 signi cant 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 signi cant impact on the critical attributes of the product.

For example

The raw material is received in a damaged container,

Manometer readings in the sampling booth 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 samples are wrongly printed with price, etc.

Critical Attribute:

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 A critical attribute is one that de nes 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 critical or major or minor in
nature.

For example:

Deviation in failure of the procedure, utility, material, equipment, or any system occurs. 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, justi able, and approved rationale. No
critical or major deviation, which has the 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 delays for various reasons.

Deviation Recording Procedure:

Deviations may be classi ed into the following two categories:

Planned Deviation

Unplanned Deviation 

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

Planned Deviation (Planned Deviation Report)

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 the 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.

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 Such planned deviation shall be properly reported, assessed/evaluated for its impact on
product quality, process performance, or GMPs.

Any personnel from the 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, a justi cation given for its
potential impact on the product quality, and compliance with regulatory requirements for the
necessity/feasibility of the deviation, by providing supporting data.

After review by the concerned Head of the 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 rst planned deviation of the year 2023.

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 ‘23’ represent the last two digits of the year 2023.
The 7th character “/” is again a forward slash.
The 8th, 9th & 10th characters ‘001’ represent a sequential number.

Head QA shall review the planned deviation with respect to the impact on product quality,
necessity/feasibility of the deviation proposed, rationale/justi cation & 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 de ned number of batch (es) or a de ned
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 a quality pro le of the
batch (es) impacted by the deviation. This data shall support 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, the Head of the concerned department and the Head of 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 the 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 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.

The user department shall make a request for the issuance of an unplanned deviation Format to
the Quality Assurance department through an Issuance form.

Any individual on the job shall inform the concerned department supervisor regarding the
occurrence of deviation and details of initial observations.

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 The concerned department personnel shall ll in the details of the unplanned deviation along
with cause and investigation details as per Annexure-II and forward the same to the
department head for review, assessment, and comments.

While reviewing, the 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 ‘The 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;

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

For example, UDR/23/001 shall be assigned to the rst unplanned deviation of the year 2023.

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 ‘23’ represent the last two digits of the year 2023.
The 7th character “/” is again a forward slash.
The 8th, 9th & 10th characters ‘001’ are sequential numbers.

QA shall maintain a logbook for the unplanned deviations as per Annexure III.

The lled form shall be forwarded to the 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 performing any additional studies if required.

If the deviation does not affect product quality, the Head – of QA shall allow further processing
of the batch in question.

If there is a probability of product quality getting affected, the 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 the secured quarantine area.

Head – QA along with the Head of the concerned department shall investigate & nd out the
root cause of the problem that resulted in the deviation as per SOP on CAPA.

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 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 the
impact on product quality and decide upon the future course of action(s).

Closure of Deviation

In conclusion, the Head – of 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 timeline for the closure of deviation (planned or unplanned) shall be not more than 30
working days. If required, an 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

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

Distribution

Master Copy- Quality Assurance

Controlled Copies -Engineering, Human Resources, 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):

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 2.0     Review by Plant Head(Comments):

QA Review / Approval and QA Comments:

Comments received from QP attached: Yes /No / NA

Any additional studies required: Yes / No
Stability Studies, Additional Quality Testing, Others
Deviation: Approved/ Rejected
The Planned Deviation is limited to time / No. of Batches: ___________
Implementation of Deviation
Deviation implemented by (department):__________________________
Observations (If any):______________________________________________
Data Generated (If any): ___________________________________________
Quality Pro le of batches affected (If applicable): _________________
Implemented By Department Head
QA Review of Implementation & Closure
QA comments: _________________________________All recommendations ful lled:  Yes /No
If No, Justi cation: ______________________________________________________
Data generation completed: Yes /  No
If No, Justi cation: ______________________________________________________
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
Closure Approved By Head-QA/ Nominee

                           

 Annexure – II

Unplanned Deviation Report

Date _______

Deviation Initiation

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

Deviation Reported By (Department): ___________________________________
Product Name: ___________Batch No.: _________Market: ___________
Batch Size: ______________Mfg. Date: _________Expiry Date: _______
Deviation related to : Procedure/Process/Equipment/Standard/Batch Size/Others( If any)
speci es:

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 Potential Impact On Quality/ Yield/GMPs/Manufacturing Process/Others ( If any) specify :
Deviation Details:________________________________________
Cause for Déviation:_____________________________________
Investigation Details:____________________________________
Proposed Corrective Action:_____________________________
Proposed Preventive Action:______________________________________
Initiated By:_______________________________________________________
Review by Department Head (Comments):
Review by Plant Head(Comments):
QA Review for implementation of CAPA (Comments):_____________
Details of any additional studies Required / Performed:____________
Review & Deviation Closure by Head – QA (Comments):_____________

Annexure -III

Log Book for Planned/Unplanned Deviation Reports

Initiated Approved Closed out

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

                 

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About Pharmaceutical Guidanace
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical
Professional from India having more than 14 years of rich experience in pharmaceutical eld. During
his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila
Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd.
During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP,
WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania,
Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can
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