Master Validation Plan SOP

and Approval Template

 Facility/Project Name –– Master Validation Plan

Document #:[MVP Document Number]

Table of Contents –– Master Validation Plan Approval Form

Master Validation Plan Approval Form...................................................................................................................A1

1.0 Purpose............................................................................................................................................................A2
2.0 Scope...............................................................................................................................................................A2
3.0 Definitions and Acronyms................................................................................................................................A2
4.0 Plant Operating Description.............................................................................................................................A3
4.1 Plant Layout.........................................................................................................................................A3
4.2 Process Flow.......................................................................................................................................A4
5.0 Project Phases / Facilities, Utilities & Equipment to be Qualified....................................................................A4
5.1 Facilities and Utilities............................................................................................................................A4
5.2 Process Equipment..............................................................................................................................A4
5.3 Packaging Equipment..........................................................................................................................A4
6.0 Qualification Requirements and Approach......................................................................................................A5
6.1 Facilities / Utilities Qualification Requirements.......................................................................................A5
6.2 Process Equipment Validation Requirements.......................................................................................A5
6.3 Packaging Equipment Qualification Requirements................................................................................A5
7.0 Product Validation Requirements....................................................................................................................A6
7.1 Process Validation Requirements & Rationale.......................................................................................A6
7.2 Packaging Validation Requirements & Rationale...................................................................................A7
8.0 Cleaning and Sanitizing Validation..................................................................................................................A8
8.1 Cleaning Validation Requirements........................................................................................................A8
8.2 Sanitization Validation Requirements....................................................................................................A9
9.0 Software Validation Requirements.................................................................................................................A10
9.1 Facilities / Utilities Qualification Requirements.....................................................................................A10
10.0 Project MVP Production Lot Release Requirements...................................................................................A10
11.0 Schedule......................................................................................................................................................A11
12.0 References...................................................................................................................................................A11
13.0 Roles and Responsibilities...........................................................................................................................A12
14.0 Revision History...........................................................................................................................................A12

[Form Number] [Form Version #]

 Facility/Project Name –– Master Validation Plan

Document #:[MVP Document Number]

Master Validation Approval Form

The following signatures are necessary for approval of the [Facility/Project Name] Master Validation Plan, for the
production of [Description of Products] at the [Company], [Location] facility.

Electronic Archival Number: E#

Department, Author –– Title

Printed Name: Name

Date: 00/00/0000
Signature:

Approved By:

Manufacturing – Lead/Management Title

Printed Name: Name

Date: 00/00/0000
Signature:

*Engineering – Lead/Management Title

Printed Name: Name

Date: 00/00/0000
Signature:

*Research & Development – Lead/Management Title

Printed Name: Name

Date: 00/00/0000
Signature:

*Project Manager – Lead/Management Title

Printed Name: Name

Date: 00/00/0000
Signature:

Quality Assurance / Compliance – Lead/Management Title

Printed Name: Name

Date: 00/00/0000
Signature:

*optional

[Form Number] [Form Version #] Effective Approval Date: A1

 Facility/Project Name –– Master Validation Plan

Document #:[MVP Document Number]

1.0 Purpose
The purpose of this Master Validation Plan is to outline the validation and qualification requirements associated
with the [project statement] or production of [Description of Products] at the [Company], [Location] facility.

This document supports Validation Policy [Validation Policy] within [Company] and will address all areas of
validation and qualification required for the [Facility].

2.0 Scope
The scope of this Master Validation Plan is for the production of [Description of Products]. The Master Validation
Plan will outline the validation and qualification requirements for Process, Packaging, and Manufacturing
Equipment; Facilities and Utilities; Cleaning and Sanitizing; Software Validation; Lab Equipment and Test Methods
per Validation Policy[Validation Policy].

• Facility and Utility Installation Qualification (IQ) Operational Qualification (OQ), and Performance Qualification
(PT) required to support the manufacture [Description of Products.
• Critical equipment and their associated control systems will be subjected to Installation Qualification (IQ),
Operational Qualification (OQ), and where applicable, integrated Performance Qualification (PQ).
• Cleaning and Sanitizing validation will be assessed and performed for all production equipment and products
manufactured in [Facility].
• Products will be validated for Process (PV) and Packaging (PkV).
• Supporting software systems will be validated

3.0 Definitions and Acronyms

Acronym Definition

Acronyms Definitions

[Form Number] [Form Version #] Effective Approval Date: A2

 Master Validation Plan SOP
SOP Document #

SOP Rev #: , Effective Date:

Table of Contents –– Master Validation Plan SOP Form

1.0 Purpose............................................................................................................................................B1
2.0 Scope...............................................................................................................................................B1
3.0 Definitions and Acronyms................................................................................................................B1
4.0 Procedure.........................................................................................................................................B4
4.1 Purpose...............................................................................................................................B4
4.2 Scope..................................................................................................................................B4
4.3 Definitions & Acronyms.......................................................................................................B4
4.4 Plant Operating Description................................................................................................B5
4.5 Plant Layout........................................................................................................................B5
4.6 Process Flow.......................................................................................................................B5
5.0 Master Validation Plan Elements.....................................................................................................B6
5.1 Facilities, Warehousing & Storage......................................................................................B6
5.2 Utilities.................................................................................................................................B6
5.3 Production Equipment.........................................................................................................B7
5.4 Product/Process Validation.................................................................................................B7
5.5 Cleaning Validation.............................................................................................................B8
5.6 Sanitizing Validation............................................................................................................B8
5.7 Software Validation.............................................................................................................B9
6.0 Additional MVP Elements.................................................................................................................B9
6.1 Signature List......................................................................................................................B9
6.2 Schedule & Resourcing (Optional) .....................................................................................B9
6.3 Project MVP Production Lot Release Requirements ........................................................B10
6.4 References .......................................................................................................................B10
6.5 Roles & Responsibilities ...................................................................................................B10
6.6 Revision History................................................................................................................B10
 Master Validation Plan SOP
SOP Document #

SOP Rev #: , Effective Date:

1.0 Purpose
This standard work describes the rationale and methods used to draft and maintain
Master Validation Plans (MVPs) at Company Name . This Standard Work outlines the
process, content and rationale for facility and project MVP documents.

2.0 Scope
This standard work provides guidance for Master Validation Plans utilized to document the
validation approach, requirements and justification for the qualification and validation of a facility
or project, including but not limited to:

• MVP Purpose and Scope

• Building and Facility Layout
• Process Description and Flow
• Qualification/Validation of:
o Facility & Utilities
o Production Equipment
o Manufacturing Processes
o Cleaning & Sanitizing
o Software Systems
• Supporting GMP quality systems to maintain a validated state

3.0 Definitions and Acronyms

Acronym Definition

Master Validation Plan Documented plan for qualification of a facility/project,

which identifies layout of the operation, associated
equipment, utilities and systems to be validated. Provides
extent of qualification/validation activities via protocols,
SOPs, acceptance criteria & responsibilities.

Validation Documented evidence that processes, procedures, and

equipment consistently lead to predetermined
expectations, specifications and quality attributes.
Collection and evaluation of data from process design stage
through commercial production, which establishes
scientific evidence that a process is capable of consistently
delivering quality products.

[SOP Number] [SOP Version #] Effective SOP Approval Date: B1

Bonus Article: Re-purposed from Journal of Validation Technology, Vol. 24, Issue 1

Validation Master Plan (VMP)

Part 1: Differences in Terminology, Content & Applications

By: Paula L. Pluta

Abstract
This discussion addresses basic considerations associated with the topic
of the Validation Master Plan (VMP). While VMP is a well-known term, its
use, structure, and content is not consistent across organizations and in the
industry. Organizations may utilize VMP very differently in their respective
sites. Further, alternate VMP terminology may be used in organizations.

This discussion identifies four different VMP types commonly used in

pharma and related industries. These include site documents, function
documents, major project documents, and single project documents.
Different terminology, content, and applications in VMPs lead to confusion.
Sites should consider developing a procedure that defines VMP and all
other terms used at their site with consideration for industry and regulatory
standards. Such a procedure will unify terminology used by personnel in the
respective areas of the site and help to clarify communications.

The site Validation Approval Committee (VAC) has a vital responsibility to

the manufacturing site and is critical to the success of the site validation
program. Whatever structure and content, the site VAC should consider
the VMP as their document. The VAC should consider themselves to be a
surrogate FDA (or other regulatory agency) auditor when they are reviewing
VMP. Clarifying and unifying VMP terminology used at a site should be
a joint responsibility of the VMP and the site validation function. The
terminology, content, and applications of VMP should be consistent with
industry and regulatory norms and expectations.

A division of UBM Americas Published on IVT Network (http://www.ivtnetwork.com)

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