This document discusses deviations that can occur during pharmaceutical manufacturing processes. It defines deviations as variations from predefined and approved procedures that could impact product quality. There are two types of deviations: planned deviations that are pre-approved, and unplanned deviations called incidents. Incidents are further classified as quality-impacting or non-impacting. The document outlines the process for reporting deviations, including documenting details of the deviation, reviewing and approving by quality assurance, and identifying and implementing corrective and preventive actions.

1. Presented By:
Mr. Sachin Ramdas Naksakhare
Roll No:-537 M.Pharm Sem-I
Dr. D .Y Patil Institute Of Pharmaceutical Science and
Research, Pimpri, Pune
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Introduction
Deviation
Types of Deviation
1] Planned Deviation
2] Unplanned Deviation
Content of Deviation Format
Reference

3.  Process deviations can be defined as variation,
in the production or any other process, from
the predefined procedure.
 Such deviations may adversely affect the
desired quality of the pharmaceutical product.
 A deviations should be generally avoided and if
exceptionally required then such deviations
must be justified and properly authorised and
recorded.
 If a particular type of deviation is occurring
frequently then such deviation must be fully
investigated and if required this may be
permanently changed through a change control
procedure.
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4.  Deviations are measured differences
between observed value and expected or
normal value for a process or product
condition, or a drifting from a documented
procedure or standard specification.
 A deviation may occur during sampling and
testing, raw materials and finished product
acceptance and manufacturing.
 A deviation is an activity performed
differently and/or modified than that
specified in an approved document.
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5.  There are two types of deviations
1. Planned Deviation
2. Unplanned Deviation/ Incidents
Unplanned deviation are again of two type.
i] Quality Impacting Incident
ii] Quality non-Impacting Incident
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6.  Planned deviations, which are described and
pre-approved deviation from the current
operational document/system, covering a
specified period of time or number of
batches.
 Planned deviation shall be approved before
execution.
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7.  Concerned department officer, executive can
raise the deviation by all details which are
mentioned in deviation form.
Details like:-
1) Document/Material/Product description
2)Item code/Document No./Batch No.
3)Current procedure
4)Proposed deviation
5)Reason for deviation and justification for
deviation
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8.  Concerned department head shall review
deviation.
 In case of any additional information
required on the deviation , department head
send back the form to the initiator.
 If the deviation is found acceptable’
department head shall make the comments
on the deviation and send to QA for further
evaluation.
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9.  QA Manager is responsible for approve or
reject.
 QA Manager shall evaluate the deviation
and send the deviation format to other
department(QC ,Engineering )if require for
their opinion.
 QA manager shall evaluate deviation report
along with the opinion of the other
department heads for the impact of
deviation.
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10.  Unplanned deviation also called as incident
.
 Incident can be defined as unplanned or
uncontrolled event in the form of non-
compliance from the designed system or
procedures at any stage manufacturing,
packaging , testing & storage of drug
product due to system failure or equipment
breakdown or manual error.
1.Unplanned deviation are again of two type
i] Quality Impacting Incident
ii] Quality non-Impacting Incident 10

11. i] Quality impacting incident:-
 Quality impacting incidents are errors or
occurrences during execution of any activity
which will affect the Quality, Purity,
Strength of the drug product.
ii] Quality non-impacting incident:-
 Quality non-impacting incident are errors
or occurrences during execution of any
activity which may have no impact on the
Quality, Purity, Strength of a drug product.
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13.  Whenever any incident occurs, the identifier
together with the department head shall
evaluate the impact of the incident on the
Quality, Purity and Strength of the product.
 For the Quality impacting incident the
identifier shall immediately notify the QA.
 All documents or operations which give an
information about the cause of the incident
shall be investigated.
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14.  To identify the root cause five generic
causes shall be considered and investigated
according to that
a) Material
b) Method
c) personal
d) Equipment
e) Environment
 Identify the probable causes, which may be
the reason of incident.
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15.  Deviation No.
 Department
 Document/Material/Equipment/ Product
 Document No./Equipment No./Batch No
 Current procedure and Proposed procedure
 Reasons and justifications.
 Corrective and preventive action
 Initiator Name, signature and date.
 QA Manager opinion: Approve/Reject
 Verification of CAPA by QA team.
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16.  Manohar A. Potdar “Pharmaceutical Quality
Assurance, Nirali Prakashan , Second
edition, December, 2007, Page No.:6.9
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