EXAMPLE

VALIDATION MASTER PLAN

Company:

Company Name*

Facility/Location:
Document #

VMP- #####

Revision 0 (First Draft)

* Throughout this document, items shown in italics are to be replaced with

the appropriate name or description.

Protocol Number: APA MVP-01

Prepared For:
IVT VALIDATION WEEK
Oct. 28-30, 2009

VALIDATION MASTER PLAN

TABLE OF CONTENTS
1.0

APPROVAL

2.0

PURPOSE

3.0

SCOPE

4.0

RESPONSIBILITIES

5.0

VALIDATION APPROACH

6.0

GENERAL ACCEPTANCE CRITERIA

7.0

FACILITY AND PROCESS DESCRIPTION

8.0

SUPPORTING DOCUMENTS AND SOPS

9.0

VALIDATION SCHEDULE

10.0

DIAGRAMS

11.0

RELEASE FOR USE

12.0

PERIODIC REVIEW

VALIDATION MASTER PLAN

1.0

APPROVAL
The approval of this Validation Master Plan shall be the responsibility of the <facility>
Validation Steering Committee (VSC) comprised of the following functional areas of the
<Company Name>.

___________________________________________
Author

_______________
Date

___________________________________________
Engineering Manager

_______________
Date

___________________________________________
Production Manager

_______________
Date

___________________________________________
Quality Assurance Manager

_______________
Date

VALIDATION MASTER PLAN

2.0

PURPOSE This Validation Master Plan serves as a summary of the overall strategy for the
validation of <facility>. The Validation Master Plan provides an overview of the each process
and describes the validation approach along with supporting validation rationale.

3.0

SCOPE

This VMP addresses the all activities related to equipment, utilities, processes, systems, and procedures
that may impact the product quality at the <facility> of the <company>. Specific systems, equipment,
utilities, and procedures to be qualified and processes to be validated shall be determined based on
documented risk assessment.
4.0

5.0

RESPONSIBILITIES
4.1

The Validation Department are responsible for preparing validation protocols, task
reports, change control documents, and validation SOPs, and for maintenance and storage
of all validation related documents.

4.2

The Plant Validation Steering Committee (VSC) (including principals from

manufacturing, QA, and Engineering) will approve the Validation Master Plan and all
validation protocols, protocol deviations, change control documents, and reports.

4.3

The <responsible individual> will review and approve SOPs for literary correctness,
technical correctness, and approval to implement.

4.4

Quality Assurance will review and approve the Validation Master Plan, validation
protocols, task reports, protocol deviations, change control documents, and SOPs for
consistency with cGMPs, consistency with <Company> policies and procedures, and
approval to implement.

4.5

Support for executing, reviewing, and approving protocols is provided by various

departments:

VALIDATION APPROACH
The purpose of the validation plan is to demonstrate that the critical equipment, systems, and
processes perform as designed and intended. All validation will be conducted prospectively
following written and approved protocols. Change control and qualification of equipment and
systems will be conducted in a manner consistent with <Company> policies and procedures.
Specific equipment, systems, and processes to be validated will be determined based on a
documented risk assessment.
5.1

Validation Protocols
Validation protocols will be identified and approved in accordance with <SOP>.
Protocols and change control documents will be drafted and approved prior to execution.
Execution of tasks associated with one qualification phase (e.g., IQ) must be completed
prior to initiating the tasks in the next phase, except that reviews and approvals are not
required to be completed before initiating the next qualification phase. Where one

VALIDATION MASTER PLAN

protocol execution follows another protocol execution, (i.e., IQ followed by OQ followed
by PQ) it is not necessary to execute post protocol approval prior to executing the
subsequent protocol. However, the <responsible individual> will be responsible for
monitoring and assessing any open issues and providing documented approval to proceed
to the subsequent protocol. Protocol deviations will be documented within each protocol
and reviewed and approved by the <responsible individual> and QA. Task reports will
be prepared to summarize the objectives and results of each qualification phase.
5.2

Change Control
All changes with potential impact on validated systems and/or processes shall be
addressed by established change management procedures <Change Control SOP>.

These changes shall be assessed against prior validation studies. A rationale must
be documented when no further validation is required.
5.3

Deviations
Deviations that occur during validation shall be documented and investigated in
accordance with <company> procedures or as defined in validation protocols.
Corrective actions taken or corrective action plans shall be reviewed and
approved prior to, or concurrent with, approval of the validation report.

5.4

Standard Operating Procedures

Standard Operating Procedures will be drafted, identified, and approved in accordance
with <Standard Operating Procedures>. However, in cases where the SOP is expected
to be modified as a result of qualification findings, it is acceptable to have only the
<responsible individual> approve the draft SOP for use during testing. Upon completion
of qualification the modified SOP will be approved by according to <Standard
Operating Procedures>. Draft SOPs used during testing will be maintained with the
protocol.

5.5

Documentation
Documentation must be available that describes the system or process to be validated.
The documentation will be used to perform the risk assessment to determine which
systems or process steps require validation and will serve as the basis for defining
validation acceptance criteria.
The documentation required for each activity will be defined within the protocol steps for
that activity. All observations and results shall be documented in a manner that allows
for objective determination of pass/fail status. All protocols shall define the expected
results and acceptance criteria. Computer printouts, charts, or other supporting
documents shall be attached to or reference in the completed protocol. Protocol
deviations shall be annotated in the protocol.
Protocols will be uniquely identified according to <SOP>. All validation documents will
be maintained according to <SOP>.
Reports should be written summarizing the results of execution of protocols after each
validation phase (e.g., IQ, OQ, PQ). Each report should include a summary of the results
obtained, analysis of the results, summary and resolution of any deviations observed,
conclusions, and raw data supporting the conclusions.

VALIDATION MASTER PLAN

Validation Documentation should be organized and retained to allow for easy retrieval.
The documentation should be retained in accordance with <company> document
retention policies and procedures.

6.0

5.6

Calibration All test equipment and instruments used in the execution of validation
tasks must be calibrated and within their calibration period.

5.7

Training
All personnel involved in the performance of qualification and validation activities must
be trained in the tasks they will be performing. Personnel responsible for the
maintenance or operation of equipment to be qualified must be trained and qualified prior
to executing the qualification studies.

GENERAL ACCEPTANCE CRITERIA

General acceptance criteria must be met for a given piece of equipment, system, or process to
ensure that it is operating properly and meeting its specific acceptance criteria as defined in the
specific protocol for the equipment, system or process.
Qualification protocols define the specific acceptance criteria that must be met to demonstrate
that the equipment or system was properly designed, installed, and operates. When
commissioning activities are performed in lieu of qualification tasks, the commissioning activities
should be verified during qualification rather than repeating the commissioning tasks.

7.0

FACILITY AND PROCESS DESCRIPTION

7.1

Facility Description:

Provide a general description of the facility and specifications. Include all of the
major areas that are included in the validation plan (central plant,
manufacturing, material storage, etc.) Reference drawings or attachments as
necessary.
Identify critical areas of the facility (GMP vs. non-GMP areas). Include zoning
and area classifications for GMP areas.
7.2

Process Descriptions:

Process Name and Description: Include a general description of the major steps
and type of equipment used in the process.
8.0

SUPPORTING DOCUMENTS AND SOPS

Standard Operating Procedures which apply to the validation master plan include:
SOP #

Calibration, Monitoring and Preventive Maintenance.

SOP #

Change Control and Deviations.

SOP #

Documentation Guidelines.

VALIDATION MASTER PLAN

9.0

SOP #

Equipment Cleaning and Verification.

SOP #

Equipment ID Numbers.

SOP #

Preparation of Specifications.

SOP #

Vendor Certification.

VALIDATION SCHEDULE
Attach a schedule of validation events. The schedule should include the following
information:
Responsibility for each task.
Human resource requirements for each task.
Contractor or vendor support if needed.
Test equipment requirements for major items or test equipment that is not readily
available.
Milestones and interdependent tasks.

10.0

DIAGRAMS
Diagrams of the <facility> depicting the facility and equipment layout should be attached
to this VMP.

11.0

RELEASE FOR USE

Prior to releasing the equipment, system or process for general production use the
following criteria must be met:
Approved SOPs shall be available for the use, control, and maintenance of
equipment, systems, and processes;
Critical instruments must be calibrated and entered into the <facility> calibration
program;
Critical system components must be entered into the <facility> preventive
maintenance program; and
Training requirements must be established for personnel.

12.0

PERIODIC REVIEW
The Validation Master Plan should be reviewed at least annually to ensure that it is
maintained current with the equipment, systems, and processes at the <facility>.
Validated systems and processes should be reviewed periodically according to risk
assessment to determine the need to re-validate. The results of the periodic review shall
be documented, reviewed, and approved by the <facility> Validation Committee.