This document provides a standard operating procedure for managing validation exceptions at a pharmaceutical company. It outlines responsibilities for identifying, documenting, investigating, approving, and closing exceptions. The procedure involves documenting exceptions in a non-conformance template, evaluating their criticality, developing corrective or preventive actions, and obtaining approval from relevant parties. The goal is to properly handle exceptions to provide continuous quality improvement and ensure validation studies and systems meet requirements before release.

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Managing Validation Exceptions
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Standard Operating Procedure
Managing Validation exceptions
References :
TGA Regulations (Australian Code of Good Manufacturing Practices for Medicinal Product, annex ii).
Prepared by department no:XXX
Validation Improvement Specialist
(date) Fatima Grangeiro Landim (FGL)
Reviewed and Approved by:
Quality Control Labs Manager
(date) QC Manager
Quality Assurance
(date) Quality Assurance Officer (Initial)
(date)

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Managing Validation Exceptions
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Table of Contents
1 Purpose and Scope..............................................................................3
2 Responsibilities ....................................................................................3
3 Definitions and Abbreviations ............................................................... 4
4 Procedure ............................................................................................ 5
5 Procedure overview .............................................................................5
5.1 Documenting the exception into the non conformance Template 5
5.2 Filling out the non conformance Report: ........................................6
6 Exception/Deviation Report ..................................................................1

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1 Purpose and Scope
The purpose of this Standard Operating Procedure (SOP) is to describe the process
of reporting, investigating, analysing, documenting and closing of Validation
exceptions (non conformance).
The purpose of properly documenting exceptions, investigations, and implemented
actions is to provide data for a continuous quality improvement within quality
management system.
Management and control of validation exception are a critical aspect of Validation
and qualification studies.
This Sop must identify why something went wrong and what has been done to make
sure it does not happen again.
This SOP must be used only to control validation exceptions, any changes to
production/operational systems must be covered by SOP XXX “Managing Change
control”.
2 Responsibilities
Person Responsibilities Final action
responsible
Identify the potential problem or non conformance during Validation
Validation the validation studies; Specialist
executor
Document validation exception or non conformance.
Review any critical or no critical exception, approve all Sign and date
systems changes required to close a validation exception; closed
exception.
System owner Ensures that all validation exceptions or changes are
closed prior to system being released for operation.
Evaluate the effectiveness of the correction (if applicable);

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Person Responsibilities Final action
responsible
Ensures that all validation exceptions are documented, Sign and date
investigated, auctioned, mitigated and reviewed and closed
approved by all relevant parts. exception.
Project Develop a plan to prevent the occurrence.
Manager Evaluate the effectiveness of the corrective/preventive
action (if applicable);
Review any corrective or preventive actions raised for the
relevant exception.
Ensures that all validation exception and project changes Sign and date
Validation are documented; closed
Manager exception.
Review any corrective or preventive actions raised for the
relevant exception.
Verify that all tasks are completed and a preventive plan is Sign and date
in place (if applicable); closed
Quality Verify the effectiveness of the action taken for the related exception.
Assurance exception;
Review and approve all system changes and correction for
the purpose of closing out all validation exceptions.
3 Definitions and Abbreviations
Definitions/Abbreviation Full text/ Explanation
Action to eliminate the cause of a detected deviation during
Corrective action
validation exercises, processes, equipments, facilities, etc.
Preventive action Action to prevent occurrence during a non conformance situation.
CFR Code of Federal Regulation
GAMP Good automated Manufacturing Practice
Generalization of quality guidelines - Good manufacturing
GXP practice, good laboratory practice, good documentation practice,
good clinical practice, good safety practice, etc.

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4 Procedure
This procedure details a process of controlling critical or non critical validation
exceptions (non-conformances) during the validation phases of the system lifecycle.
5 Procedure overview
The following steps are an overview of the key sections in the management of
validation exceptions.
1. Identify an exception during validation exercises;
2. Evaluate the criticality of the exception;
3. Raise a validation exception;
4. Document the validation exception in the approved template ;
5. Obtain the exception number (Project number + 01for first project exception);
6. Create an excel sheet and document exception number, description, status
for every project validation exception;
7. Reviewing the validation exception for errors;
8. Document into exception template, the exception number, person who raised
exception, date of exception was raised, exception details, exception
criticality, corrective/and or preventive actions, any impact assessment has
been performed.
9. Documented exception signed and dated by the author and submitted to the
approval team (refer to responsibility matrix on section 2 of this document).
5.1 Documenting the exception into the non conformance
Template:
1) Identification: After the exception is identified, a full report must accurately
describe the situation.
A detailed explanation of the problem must be in clear language, if necessary further
information such as drawings, data sheets, calibration certificate, etc should be
attached to the exception report as an evidence that the problem exist.
2) The situation/exception was identified and documented, a full evaluation of the
problem must be done and also documented (an in depth root cause analysis).
The evaluation of the situation is necessary to determine the criticality of the
problem, and if further actions need to be implemented.
The result of the evaluation must document the impact that the problem may have in
the system, safety, cost, and product quality.
3) Corrective /and or preventive actions.

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If the problem needs further investigation and actions to be closed, the result of the
investigation must be fully documented. A remedial action can be achieved until a
permanent solution is implemented.
An identification of the appropriate actions documented and fully verified.
A follow up section must be present into the exception template , and if the problem
can be closed without further investigation or actions to be implemented, the
exception can be reviewed, approved closed by the relevant personnel.
4) Submit the hardcopy for review, any change to the submitted document must be
documented and document updated (if necessary);
5) If action documented into the non conformance report were unsuccessful, further
actions must be documented (if applicable), and again report must be submitted for
review and closure by the System owner, Project Manager and QA representative.
6) If non conformance report was cancelled, document the details of the cancelled
report. Submit report for review and approval/closure by the System owner, Project
Manager and QA representative.
7) Previous investigation that relates to the same deviation must be reviewed to
determine if the problem is new or is the recurrence of the same previous problem
investigated during the execution of the same or other projects.
5.2 Filling out the non conformance Report:
Exceptions Final action
Document exception into non Provide evidence: What, When, Who, Where and
conformance template How much.
Define problem; Review evaluate information gathered
from the problem description.
Investigate Clearly identify cause (s) of the problem, or any
contributing factors.
Describe the actions, the action responsible, deadlines
Planning actions (if applicable) for actions to be completed, necessary documents or
tools to finalise actions.
Actions verifications Verify that the proposed actions will satisfy the
requirements for the open exception.
Approved and closed Verify that the reviewed and approved exception is
exceptions closed and non further actions are necessary.

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6 Exception/Deviation Report
Deviation Report
Protocol number :
Number of deviation:
Deviation description :
Signed by: Date: Init:
Reason and proposal of corrective action:
Signed by: Date: Init:

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Managing Validation Exceptions
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Conclusion:
Signed by: Date: Init:
QA Approved by: Date: Init:

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Change History
Edition Effective date Description of change Revised without
changes
Date / Sign.
1.0 January 2011 Initial version