Master Validation Plan SOP

and Approval Template

Master alidation Plan
Approval Form
 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

 Facility/Project Name –– Master Validation Plan

Document #:[MVP Document Number]

4.0 Plant Operating Description

Provide design philosophy for maintaining supporting and maintaining product quality, including what standards
and regulations the plant is intended to meet. Specify high level description intended product types/production.
Note material, personnel and waste flow.

The manufacturing facility is constructed to [design basis for plant]. The facility is located in [location];
classified as a [description/classification] production facility per [standards]. The facility has the capability to
produce [product description]

Building construction and design consists of [facility design philosophy] to facilitate [product description].
Supporting utility systems include:
• Heating, ventilation, and air conditioning (HVAC)
o [Classification, Capacity & specifications]
• Water [grade]
o [Classification, Capacity & specifications]
• Compressed air
o [Classification, Capacity & specifications]

[List other utilities with grade & specifications]

• Dust collection
• Temperature controlled rooms
• Plant Steam
• Gases
• Cleanser/Sanitizer/Sterilizer

Brief Project/Plant history, and description of plant zones.

4.1 Plant Layout

Describe Plant Layout for each zone:

• Raw material receipt, testing, storage & release process

• Processing layout including cleaning & equipment storage
• Warehouse, storage and staging
• Personnel, Plant Access, Production Space, Gowning, Office, Team/Locker, Rest rooms,
Housekeeping & Training space

[Form Number] [Form Version #] Effective Approval Date: A3

 Facility/Project Name –– Master Validation Plan

Document #:[MVP Document Number]

4.2 Process Flow

Describe entire process flow, such that someone could understand the operation without touring it:

• Incoming/Receiving
• Warehousing/Temperature Controlled Space
• Software Systems used in release
• Production process description
• Cleaning/Sanitizing equipment
• Quality checks, product testing & release.

5.0 Project Phases / Facilities, Utilities & Equipment to be Qualified

This document provides a summary of all critical systems [Facility/Project].

This [project/facility] includes the following critical systems:

5.1 Facilities and Utilities

• List systems
• Purified Water System

5.2 Process Equipment

• List unit operations
• Mix Tank

5.3 Packaging Equipment

• List packaging equipment
• Filler

[Form Number] [Form Version #] Effective Approval Date: A4

 Facility/Project Name –– Master Validation Plan

Document #:[MVP Document Number]

6.0 Qualification Requirements and Approach

6.1 Facilities / Utilities Qualification Requirements
The following tables summarize the facility and utility systems that require qualification in
[Project]. Installation (IQ), Operational (OQ), and/or Performance (PQ) qualification protocols
can be written individually or as one combined protocol. Equipment will be validated as
systems wherever possible and practical and will be qualified per equipment qualification SOP
[Qual SOP].

[Justification for Qualification approach] [Risk Assessment reference].

Table 1: Qualification Requirements – Facility/Utilities

Building / System Name Required Qualification

System 3 IOQ Protocol / IOQ Report 3

System 4 IOQ Protocol / IOQ Report 2

6.2 Process Equipment Validation Requirements

The following tables summarize the [processing equipment] validation requirements in
[Project/Facility]. Installation (IQ), Operational (OQ), and/or Performance (PQ) qualification
protocols can be written individually or as one combined protocol. Equipment will be qualified
as systems wherever possible and practical and will be qualified per equipment qualification
SOP [Qual SOP]

[Justification for Qualification approach] [Risk Assessment reference]

Table 2: Qualification Requirements – Process Equipment

Building / System Name Required Qualification

Equipment 2 IOQ Protocol / IOQ Report 1

Equipment 2 IOQ Protocol/IOQ Report 2

6.3 Packaging Equipment Qualification Requirements

Packaging Equipment Qualification Requirements

[Form Number] [Form Version #] Effective Approval Date: A5

 Facility/Project Name –– Master Validation Plan

Document #:[MVP Document Number]

7.0 Product Validation Requirements

Process (PV) and packaging validation (PkV) will be performed on [the following products or products family].
Validation is performed to demonstrate that the manufacturing process is reproducible and can consistently
deliver product that meets release specifications. A family or grouping approach will be used whenever
possible and/or practical to validate products.

7.1 Process Validation Requirements & Rationale

Based on [rationale], the validation strategy will require process validation, packaging validation,
cleaning and sanitization validation. Validation will utilize increased levels of sampling and testing to
demonstrate the manufacturing process [is robust, define]. The [Product/Process Validation
Procedure] (VAL-SOP-XX) describes the general expectations and approaches used during process
and packaging validation activities. Additionally, it identifies the plans for documenting, with a high
degree of assurance, that manufacturing processes are capable and reproducible. [Rationale &
Justification for Process Validation Requirements, based on demonstrated product knowledge.
Reference process development work and data]

A family grouping approach will be employed wherever practical, based on process similarity and
product type. [Rationale & Justification for family selection] [Risk Assessment reference].
[ie. Justification provided for the similarity of process steps or product characteristics to group the
family of products. Scientific rationale included in reasoning for why product groupings were chosen,
which could be based on various factors, such as: similar process steps, similar raw
materials/ingredients, like base pre-mix with colorant or fragrance variation, etc.]

Where a worst-case product is utilized to represent a product family, the rationale or characteristics
as a worst-case will be documented in individual process validation documents. Thus, as a
representative product is utilized during validation, the product family is considered validated as a
result. There are [number of product families] product families to be validated in [Plant/Facility]. The
product families are: [list].

Table 3: Process Validation Requirements

Product Formulation Number and Description
Product Family Formula Number –– Product Description Validation Requirement

Formula # – Product Name 1

[Number] batches of [product] will be
challenged to represent the [product family].
Formula # – Product Name 2
Product Family Formula # – Product Name 3

Formula # – Product Name 4

Formula # – Product Name 5

The validation protocols will also define the batch size, number of batches, sampling
requirements, which may require additional sample points and/or additional tests be performed.

[Form Number] [Form Version #] Effective Approval Date: A6

 Facility/Project Name –– Master Validation Plan

Document #:[MVP Document Number]

7.2 Packaging Validation Requirements & Rationale

Validation will utilize increased levels of sampling and testing to demonstrate the packaging
process [is robust, define].

[Rationale & Justification for Packaging Validation Requirements, based on demonstrated product
knowledge. Reference process development work and data].

A family grouping approach will be employed wherever practical, based on process similarity
packaging parameters. [Rationale & Justification for family selection] [Risk Assessment reference].

[ie. Justification provided for the similarity of process steps or product characteristics to group the
family of products. Scientific rationale included in reasoning for why product groupings were
chosen, which could be based on various factors, such as: similar process steps, similar raw
materials/ingredients, like base pre-mix with colorant or fragrance variation, etc.]

Where a worst-case product is utilized to represent a product family, the rationale or characteristics
as a worst-case will be documented in individual packaging validation documents. Thus, as a
representative product is utilized during validation, the product family is considered validated as a
result.

There are [number of product families] product families to be validated in [Plant/Facility]. The
product families are: [list].

Table 4: Process Validation Requirements

Packaging Number and Description

Product Family Packaging / SKU Product Description Validation Requirement

[SKU] - Product Name 1 [Number] batches of [product] will be challenged to

represent the [product family].
[SKU] - Product Name 2
Family Name [SKU] - Product Name 3

[SKU] - Product Name 4

[SKU] - Product Name 5

The validation protocols will also define the batch size, number of batches, sampling
requirements, which may require additional sample points and/or additional tests be performed.

[Form Number] [Form Version #] Effective Approval Date: A7

 Facility/Project Name –– Master Validation Plan

Document #:[MVP Document Number]

8.0 Cleaning and Sanitizing Validation

Cleaning and Sanitizing validation is performed for processes used to clean and sanitize product-contact
equipment surfaces. Cleaning and sanitizing processes are validated by using the representative or worst-case
product for each applicable product family for each applicable cleaning SOP/equipment group.

The [Cleaning and Sanitizing Validation Procedure] (VAL-SOP-XX) describes the general expectations and
approaches used during cleaning and sanitizing validation activities. Additionally, it identifies the plans for
documenting, with a high degree of assurance, that cleaning and sanitizing processes are effective when
utilized with product contact equipment surfaces.

Product families are determined based on the following criteria: [list family criteria]
Product solubility in the appropriate cleaning solution (aqueous, solvent, alcohol), base products which contain
allergens, the toxicity of a component or marker (if applicable), the solubility of the component or marker (if
applicable) and the past history of how easy/difficult the product is to clean and the frequency in which the
product is manufactured.

[Worse case product(s) and justification] [Risk Assessment reference]

The table below identifies the product families for the products manufactured in [Project/Facility].

8.1 Cleaning Validation Requirements

Equipment & procedure grouping with justification.

Product Family Description

Product Family Name 3 Family description and characteristics 3

Product Family Name 4 Family description and characteristics 4

[Form Number] [Form Version #] Effective Approval Date: A8

 Facility/Project Name –– Master Validation Plan

Document #:[MVP Document Number]

Table 6: Cleaning Validation Requirements

Cleaning SOP/SW Validation

Product Family Worst Case Product(s) Procedure
Numbers Requirements

Product Family Worst Case Product Procedure Cleaning SOP/SW Cleaning Validation
Numbers Protocol & Report

8.2 Sanitization Validation Requirements

Sanitizing processes are validated for each applicable sanitizing SOP and equipment group.
Equipment that is of identical or similar design, geometry, operating principle and materials of
construction may be grouped when performing validation, provided that the same sanitizing
procedures are used for the grouped equipment.

[Equipment grouping rationale] [Risk Assessment reference]

Table 7: Sanitizing Validation Requirements

Equipment Sanitizing Document Sanitizing SOP Validation Requirements

Equipment Family 1 Sanitizing SOP 1 SV Protocol & Report 1

Equipment Family 2 Sanitizing SOP 2 SV Protocol & Report 2

[Form Number] [Form Version #] Effective Approval Date: A9

 Facility/Project Name –– Master Validation Plan

Document #:[MVP Document Number]

9.0 Software Validation Requirements

9.1 Facilities / Utilities Qualification Requirements
The following tables summarize the facility and utility systems that require qualification in [Project].
Installation (IQ), Operational (OQ), and/or Performance (PQ) qualification protocols can be written
individually or as one combined protocol. Equipment will be validated as systems wherever
possible and practical and will be qualified per equipment qualification SOP [Qual SOP].

[Justification for Qualification approach] [Risk Assessment reference].

Table 8: Qualification Requirements – Facility/Utilities

System Name System Purpose Required Validation

System 3 System Purpose 3 IOQ Protocol / IOQ Report 3

System 4 System Purpose 2 IOQ Protocol / IOQ Report 4

10.0 Project MVP Production Lot Release Requirements

The following table represents all the requirements for release of each product manufactured as the
result of [Project].

[Form Number] [Form Version #] Effective Approval Date: A10

 Facility/Project Name –– Master Validation Plan

Document #:[MVP Document Number]

Table 9: Production Lot Release Requirements

Product Formulation Number and Description Lot Release Requirements

Formula Number /
Product Description / Family Validation Closure
Number of Batches

Formula Number/ Product Description /

Number of Batches Family [List Validation Criteria]
No validation testing is required for the following
products, this family validated by [Representative
• Equipment Qualification
Product]. • Facility Qualification
• Utility Qualification
• Process Validation
• Packaging Validation
• Cleaning Validation
• Sanitizing Validation

List of remaining family products

11.0 Schedule
List project or validation milestones and requisite timing.

12.0 References
• Validation Policy: DOC-####
• Equipment Qualification SOP: DOC-####
• Facility Qualification SOP: DOC-####
• Utility Qualification SOP: DOC-####
• Cleaning and Sanitizing Validation SOP: DOC-####
• Good Documentation Practices SOP: DOC-####
• Plant/Project Standards: DOC-####
• Quality Manual: Reference

[Form Number] [Form Version #] Effective Approval Date: A11

 Facility/Project Name –– Master Validation Plan

Document #:[MVP Document Number]

13.0 Roles and Responsibilities

Validation activities will be administered and/or carried out based on the roles and responsibilities in the
[Roles SOP/Standard]. Responsibilities for the activities associated with the validation and qualification
requirements are outlined below.

Table 10: Roles and Responsibilities

Department Responsibilities

Department Name 1 Responsibilities 1

Department Name 2 Responsibilities 2

Department Name 3 Responsibilities 3

Department Name 4 Responsibilities 4

Department Name 5 Responsibilities 5

Department Name 6 Responsibilities 6

14.0 Revision History

Revision # Reason For Change Date

Revision # Reason for Change 00/00/0000

[Form Number] [Form Version #] Effective Approval Date: A12

Master alidation
SOP Form
 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

 Master Validation Plan SOP
SOP Document #

SOP Rev #: , Effective Date:

Validation Protocol A written plan stating how validation efforts will be

conducted. Includes test parameters, equipment/product
characteristics, and acceptance criteria to provide
documented evidence that a system, process or
equipment meets specifications or intended use.

Acceptance Criteria Specified indicators or measures employed in assessing the

ability of a component, structure, or system to perform its
intended function.

Equipment Qualification Documented evidence demonstrating that equipment is

designed/selected adequately, installed properly and
operates/performs for its intended purpose. Adequate
controls are confirmed, and the equipment is shown to be
in a state of control

Facility Qualification Documented evidence demonstrating that a production

facility is designed, selected and constructed adequately to
support manufacturing and not adulterate the product.

Utility Qualification Documented evidence demonstrating that a production

utility is designed/selected adequately and
operates/performs for its intended purpose to support
manufacturing and not adulterate the product.

Installation Qualification Documented verification that all aspects of a system,

(IQ) facility, utility or equipment that can affect product quality
are installed according to specifications and design criteria.

Operation Qualification Documented verification that all aspects and functions of a

(OQ) system, facility, utility or equipment that can affect
product quality operate properly within all anticipated
operating ranges as required by the process, capability,
procedures and design specification.

Performance Documented verification that all aspects of a system,

Qualification (PQ) facility, utility or equipment that can affect product quality
produce the required output over an extended period
under typical operating conditions and interferences.

Process Validation (PV) Documented evidence intended to examine the chemical

characteristics of the formula during the entire production
process, to ensure it meets specified strength, potency,

[SOP Number] [SOP Version #] Effective SOP Approval Date: B2

 Master Validation Plan SOP
SOP Document #

SOP Rev #: , Effective Date:

purity and/or quality attributes. All operations that may

impact product characteristics must be examined.

Cleaning Validation (CV) Documented evidence which provides a high degree of

assurance that an approved cleaning procedure will
remove from equipment product and cleansers below
acceptable limits, such that it is suitable for processing a
product.

Sanitizing Validation Documented evidence which provides a high degree of

assurance that an approved sanitization procedure will
reduce microbes and provide equipment contact surface
bioburden reduction below acceptable limits, such that it
is suitable for processing a product.

Critical Equipment Equipment that has direct product contact/impact or

ensures proper labeling and traceability of the product.
Equipment which can affect the strength, identity, purity,
potency, quality and/or quality of the product.

Software Validation Confirmation by examination and provision of objective

evidence that software specifications conform to user
needs and intended uses, and that the particular
requirements implemented through the software can be
consistently fulfilled.

Critical Process A process parameter that must be controlled within

Parameter (CPP) predefined limits to ensure the product meets its pre-
defined quality attributes

Critical Quality Attribute A CQA is a physical, chemical, biological, or microbiological

(CQA) property or characteristic that should be within an
appropriate limit, range, or distribution to ensure the
desired product quality.

[SOP Number] [SOP Version #] Effective SOP Approval Date: B3

 Master Validation Plan SOP
SOP Document #

SOP Rev #: , Effective Date:

4.0 Procedure
The MVP will provide a documented plan for qualification and validation of a facility/project, which
identifies layout of the operation, associated equipment, utilities and systems to be validated. The
MVP provides an organized summary of the facility/plant validation programme, including the
extent of qualification/validation activities via protocols, SOPs, acceptance criteria &
responsibilities.

The MVP will also provide the design philosophy for maintaining supporting and maintaining
product quality, including what standards and regulations the facility is intended to meet. Within
each section of the MVP, provide justification and rationale for the validation approach and
requirements of each validation element.

4.1 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].

4.2 Scope
Provide the product(s) description/list and validation elements within the scope of the MVP.
Provide a list of the validation elements, for example:
• Facility Qualification
• Utility Qualification
• Production Equipment Qualification
• Process Validation
• Packaging Validation
• Cleaning Validation
• Sanitizing/Sterilizing Validation
• Software Validation

4.3 Definitions and Acronyms

Provide a listing of relevant definitions and/or acronyms.

[SOP Number] [SOP Version #] Effective SOP Approval Date: B4

 Master Validation Plan SOP
SOP Document #

SOP Rev #: , Effective Date:

4.4 Plant Operating Description

Provide the plant/facility design philosophy for maintaining supporting and maintaining product
quality, including what standards and regulations the plant is intended to meet. Include the
location of the facility/project.

Reference applicable standards utilized to design and construct the facility, including intended
capabilities and classifications to adequately support product quality.

Specify a high-level description intended product types/production. Note the flow of material,
personnel and waste into/within/out of the facility, utilizing diagrams where helpful (optional).
Provide a brief Project/Facility history, with a description of plant zones. List supporting utilities
with classifications, capabilities and specifications, as well as facility classification.

4.5 Plant Layout

Describe Plant Layout for each zone:

• Raw material receipt, testing, storage & release process

• Processing layout including cleaning & equipment storage
• Warehouse, storage and staging
• Personnel, Plant Access, Production Space, Gowning, Office, Team/Locker, Rest rooms,
Housekeeping & Training space

4.6 Process Flow

Provide a sufficiently detailed description of the process flow, to characterize the manufacture of
product. Describe the process flow in a methodical and organized manner. Mention all major
unit operations, how they are utilized, and relevant process steps. Also include what controls are
in place to control the quality, status, and release of materials and stock at relevant phases of
manufacture. Include all relevant aspects of processing to define the manufacturing process,
including (but not limited to):

• Incoming/Receiving
• Warehousing/Temperature Controlled Space
• Software Systems used in release
• Production process description
• Cleaning/Sanitizing equipment
• Quality checks, product testing & release

[SOP Number] [SOP Version #] Effective SOP Approval Date: B5

 Master Validation Plan SOP
SOP Document #

SOP Rev #: , Effective Date:

5.0 Master Validation Plan Elements

Specify the extent of qualification/validation required to support manufacture of the product safety,
identity, strength, purity, potency, and quality of the product via protocols, SOPs, acceptance
criteria & specifications.

Within each element, provide justification and rationale for the validation approach and
requirements of each validation element. Provide a description of risk analysis or risk-based
approach utilized in developing the validation approach where applicable (optional). Provide a list
of validation and protocol requirements for each validation element. Reference supporting
development programs, and relevant qualification/validation procedures where applicable.

5.1 Facilities, Warehousing & Storage

State the validation requirements for the facility, warehouse(s), and other product impactful storage
locations. Provide justification, and risk-assessment (optional), for the validation approach. List,
or reference a master list, for each element and validation protocol number (with status).
Reference Facility and Storage qualification procedures which dictate and support the validation
activities.

Examples can include (but are not limited to):

• Production Facility
• Incoming / Intermediate / Bulk / Finished Good Warehousing
• Controlled Temperature / Refrigeration Units
• HVAC for air quality, temperature & humidity control

5.2 Utilities
State the validation requirements for each product supporting utility, including critical testing
requirements as applicable (ie, Purified Water system testing for 30 consecutive days). Provide
justification, and risk-assessment (optional), for the validation approach. Provide a list, or reference
a master list, for each systems, equipment ID and validation protocol number (with status).
Reference Facility and Storage qualification procedures which dictate and support the validation
activities.

Utility examples can include (but are not limited to):

• RO Water System
• Steam
• Compressed Air
• Gases

[SOP Number] [SOP Version #] Effective SOP Approval Date: B6

 Master Validation Plan SOP
SOP Document #

SOP Rev #: , Effective Date:

5.3 Production Equipment

Qualification will be performed on Critical equipment to ensure it operates and performs
according to its intended use. Provide the validation requirements for each critical production unit
operation (ie, Mix Tank).

Provide a list, or reference a master list, for each system, equipment ID and validation protocol
number (with status). Provide justification, and risk-assessment (optional), for the validation
approach.

Examples can include (but are not limited to):

• Mix Vessels & Agitators
• Product Coder
• Product Transfer Pumps
• Product Filler

5.4 Product/Process Validation

Process (PV) (template notes, packaging validation if applicable) and packaging validation (PkV)
will be performed to demonstrate that the manufacturing process is reproducible and can
consistently deliver product that meets release specifications.

State the products/product families requiring validation. Provide the Rationale & Justification for
Process Validation Requirements, based on demonstrated product knowledge. Reference
process development work and data as applicable for support.

If a family approach is utilized, provide Rationale & Justification for the family selection.
Justification can be provided for the similarity of process steps or product characteristics to group
the family of products. Scientific rationale included in reasoning for why product groupings were
chosen, which could be based on various factors, such as: Critical Processing Parameters
(CPPS), similar process steps, similar raw materials/ingredients.

Where a worst-case product is utilized to represent a product family, the rationale or

characteristics as a worst-case will be documented. Note the basis for defining batch size,
number of batches, sampling requirements, which may require additional sample points and/or
additional tests be performed.

State the validation requirements for each critical production unit operation (ie, Mix Tank).
Provide a list, or reference a master list for each formula/SKU and associated validation protocol
number.

[SOP Number] [SOP Version #] Effective SOP Approval Date: B7

 Master Validation Plan SOP
SOP Document #

SOP Rev #: , Effective Date:

5.5 Cleaning Validation

Cleaning Validation will be performed to demonstrate that the cleaning process(es) is/are
reproducible and can consistently remove product and cleanser to acceptable limits.

State the cleaning families requiring validation. Provide the Rationale & Justification for selection
of the families. Reference cleaning development work as applicable for support.

Provide Rationale & Justification for the family selection. Scientific rationale included in reasoning
for why cleaning families were chosen, which could be based on various factors, such as:
cleanser, Maximum allowable carryover (MACO), raw material/components similarity, solubility,
and coupon studies.

Where a worst-case product is utilized to represent a cleaning family, the rationale or

characteristics as a worst-case will be documented. Note the basis for defining acceptance limits,
MACO, markers for cleanliness, product/raw toxicity, cleanser toxicity.

State the validation requirements for each cleaning family. Provide a list, or reference a master
list, for each cleaning process and associated validation protocol number.

5.6 Sanitizing Validation

Sanitizing Validation will be performed to demonstrate that the sanitizing process(es) is/are
reproducible and can consistently reduce microbes/bioburden to acceptable limits.

State the equipment groups requiring sanitizing validation. Provide the Rationale & Justification
for selection of the groups. Reference development work as applicable for support.

Provide Rationale & Justification for the equipment groupings. Scientific rationale included in
reasoning for why equipment groups were chosen, which could be based on various factors, such
as: sanitizer, concentration, contact time, equipment geometry/size, coupon studies. Note the
basis for defining acceptance limits, and reference the environmental monitoring program.

State the validation requirements for each sanitizing group. Provide a list, or reference a master
list, for each sanitizing process and validation protocol number (with status).

[SOP Number] [SOP Version #] Effective SOP Approval Date: B8

 Master Validation Plan SOP
SOP Document #

SOP Rev #: , Effective Date:

5.7 Software Validation

Cite each software system, and a brief description of the systems purpose to support the product.
Provide the validation requirements for each software system. Provide a list, or reference a
master list, for each system and qualification protocol number (with status). Provide justification,
and risk-assessment (optional), for the validation approach.

Examples can include (but are not limited to):

• Computerized Manufacturing Maintenance System (CMMS)
• Laboratory Information Management System (LIMS)
• Warehouse Management System
• Manufacturing Execution System(s) (MES)

6.0 Additional MVP Elements

6.1 Signature List
The purpose of the signature list is to ensure that all functional involved in the execution and support
of the MVP and validation program are aware of the MVP requirements. At a minimum, Manufacturing
and Quality Assurance management will approve of the MVP, to ensure the application and
maintenance of the facility/project validation program. Other functions may also approve of the MVP,
as applicable, to ensure proper support of the validation and validated state of the plant/facility.

1) Plant Engineering
2) Research & Development
3) Project Management
4) Maintenance
5) Metrology
6) Change Control

6.2 Schedule & Resourcing (Optional)

List the project/facility or validation milestones, and requisite timing. Note the expected validation
resource requirements to support development, drafting, execution and closure of validation activities.

[SOP Number] [SOP Version #] Effective SOP Approval Date: B9

 Master Validation Plan SOP
SOP Document #

SOP Rev #: , Effective Date:

6.3 Project MVP Production Lot Release Requirements

The validation release requirements for product will be specified. Product release requirements
for product families, including their representative (or worst case) products as well as the
remaining products will be stated. Requirements for release could include (but may not be
limited to) successful completion of:

• Equipment & Utility Qualification

• Process Validation
• Cleaning & Sanitizing Validation
• Successful environmental monitoring program results

6.4 References
Cite references to qualification and validation procedures within the validation program. Also
reference other relevant procedures and programs required to maintain production in a state of
control. These can include (but are not limited to):

• Master Validation Plan Form: DOC-####

• Validation Policy: DOC-####
• Qualification & Validation Procedures
• Good Documentation Practices SOP: DOC-####
• Facility/Project Standards: DOC-####
• Change Control Policy: DOC-####
• Training Program: DOC-####
• Calibration/Metrology/Preventive Maintenance Program: DOC-####
• Quality Manual: DOC-####

6.5 Roles & Responsibilities

Validation activities will be administered and/or carried out based on the roles and responsibilities
in the corporate standards. Cite each department’s roles & responsibilities, or reference
applicable corporate departmental responsibilities documents.

6.6 Revision History

Track the revision history of the MVP, including dates of approval and change log. The MVP will
be maintained and stored in accordance with Corporate Records Retention guidelines.

[SOP Number] [SOP Version #] Effective SOP Approval Date: B10

alidation Master Plan
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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Introduction
Validation Master Plan (VMP) is a universally
known term. Essentially all pharmaceutical and
related industry manufacturing sites have some
type of VMP in their facility. Despite widespread
awareness of VMP, there is great diversity re-
garding its structure, content, and application.
Meetings with validation professionals at phar-
maceutical meetings indicate much different
understandings of the VMP -- the VMP to cer-
tain individuals is not the same as the VMP to
others. The more people involved, the more
companies represented, the more industries
represented, and the geographic diversity of
attendees all contribute to increasing confusion
when attempting to discuss VMP structure,
content, and application. Validation managers
comment about frustration with inconsistent
terms used between various functional groups
even within their facilities. VMP is widely known
in general, but specifics are not universally con-
sistent.
This discussion identifies basic categorizes
of VMP as presented at pharma meetings, in
published papers, and in group and personal
discussions. Four different types of documents,
all of which are termed VMP, are addressed.
Other less frequently used terms for VMP are
also described.
VMP – Terminology & Structure
A lack of uniformity in VMP terminology
and structure is a definite impediment in discus-
sions about VMP. Validation managers attend-
ing VMP discussions at pharma meetings often
leave more confused after attending a VMP
session than before it started because of differ-
ences in terminology and structure. A participant
may describe their VMP as a comprehensive
site document while other participants
understand VMP to be the validation approach
for a specific project. The more participants in
the discussion, the greater the diversity in
opinions, and the greater the confusion.
This discussion addresses four VMP
approaches experienced by the author in pre-
sentations and discussions at pharma meetings
and in written submissions to the Journal. These
include the following:
1. VMP – Site document. This document comprises
all fundamental information about the site. It includes
specific individual sections about functions at the site.
2. VMP – Function document. This document com-
prises all fundamental information about a specific
function at the site. A VMP function document is
one of the sections in the above-described VMP site
document
The above two categories may be considered
validation overview documents describing the
general validation program at a site.
3. VMP -- Major project document. This document
comprises all information about a specific major
validation project at the site such as a new facility ad-
dition with multiple validation activities and protocols.
4. VMP -- Single project document. This document
comprises all information about a specific individual
validation project at the site. This document is one
of the sections in the above-described VMP major
project document
Documents #3 and #4 are specific validation
project documents containing project details.
The above four categories are the most
widely used terms associated with VMP. There
are numerous lesser-used terms also used with-
in organizations to describe equivalent informa-
tion. A recent industry meeting with representa-
tion from pharma, medical devices, nutritionals,
blood processing, and other validation-com-
pliant regulated industries from USA, Canada,
Puerto Rico, and other global sites reported a
variety of VMP and associated terminology.
In addition to VMP, other terms included
validation plan, qualification master plan, qual-
ification plan, project plan, validation project
master plan, qualification project master plan,
validation approach, qualification approach,
validation strategy, qualification strategy, proj-
ect strategy, project approach, and many other
terms. Some organizations do not have a specif-
ic VMP, but simply list validation documents in a
spreadsheet.
Other terms along with common asso-
ciated terms such as Factory Acceptance Test
(FAT), Site Acceptance test (SAT), Installation
Qualification (IQ), Operational Qualification (OQ),
Process Qualification (PQ), combination terms
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such as IOQ and IOPQ, and similar terms make
for potentially great confusion, both within the
site and with external auditors.
Sites should consider developing a docu-
mented and approved procedure defining terms
used at their site. Such procedure will unify
terminology used by personnel in the respec-
tive areas of the site. When developing such a
procedure, industry and regulatory norms and
expectations should be considered.
This document will further serve to clarify
terms when the site is audited by regulatory or
other outside auditors. Preparing a lexicon will
also obviate the need to make changes in nu-
merous site documents such as the FDA change
to Process Performance Qualification (PPQ)
from process validation (PV). Confusion with
inconsistencies in global regulatory documents
will be minimized with an approved site lexicon.
VMP – Site Document
The VMP site document is one of the
most common types of VMP. This document
comprises all fundamental validation information
about the site. It includes individual sections
about specific validation functions at the site.
For example, specific sections with describe the
facility design, equipment program, HVAC pro-
gram, cleaning program, manufacturing process
program, and so on. All these sections are con-
tained in a single major document or electronic
file under the responsibility of the site Validation
/ Quality function.
The site VMP is a critical document.
Early review of the VMP by regulatory audi-
tors often sets the tone for the remaining days
of inspection. A thorough and well-designed
VMP demonstrates a well-run facility. A current
/ recently-updated VMP further conveys the
message that the VMP is valued and useful to
the organization. A site that expends good effort
in the design and maintenance of the VMP will
reap benefits both internally and with external
auditions. A site VMP may be divided into indi-
vidual chapters such as the following:
� VMP Introduction, Scope, and Objectives
� Responsibilities
� Site Facility Overview and Design
� General Validation / Qualification Approach
� Facility Heating, Ventilation, and Air Conditioning
� Utilities
� Equipment
� Computer Systems
� Products and Manufacturing Processes
� Cleaning
� Analytical Methods
� Appendix
� Projects – Current and Completed
� Facility Heating, Ventilation, and Air Conditioning
(HVAC) Qualifications
� Utilities Qualifications
� Equipment Qualifications
� Computer Systems Qualifications
� Products and Manufacturing Process Validations
� Cleaning Validations
� Analytical Methods Validation
Projects
Some companies describe validation-re-
lated projects in the VMP. Other companies
prefer not to list ongoing project work. Auditors
have expressed that a documented prior com-
mitment to an ongoing project may eliminate it
as a regulatory citation, i.e., the site is aware of
the deficiency and is addressing the problem.
Appendix Reference List of Validations & Qualifications
This section lists the current complete
validation for each equipment, process, clean-
ing, and so on. When an auditor asks for the val-
idation supporting a specific topic, this section
provides the reference and facilitates access to
approved documentation.
VMP Update
The VMP site document must be updated
to retain its usability. The updating frequency
depends on the frequency of external audits.
Quarterly updates are done by many validation
managers.
VMP – Function Document
The VMP function document comprises
all fundamental information about a specific
validation function at the site. This document is
one of the sections in the above-described VMP
site document. For example, a manufacturing
process VMP would include a list of all products
manufactured at the site, product groupings, all
SOPs associated with product manufacturing,
references to all process validation, and other
relevant information.
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 This information is contained in a single
major document or electronic file under the
responsibility of the site manufacturing process
or product technical support function. A site
would thus have multiple VMP function docu-
ments dispersed among the respective depart-
ments at the site. A function VMP should con-
tain all relevant validation information associated
with the function. For example, the content of
cleaning validation function VMP may include
the following:
� Strategy and approach
� Comprehensive lifecycle approach, Science and
technical basis, Risk analysis, variation identification
and control
� Policies
� Approved procedures
� Supporting information with reference
documentation
� Product cleaning matrix
� Equivalent equipment
� Equipment surface area calculations
� Residue calculations
� Technical reports references
� Templates
� Validation commitments and timelines
� Planned validations
� Improvement projects and timelines
� Cleaning validation references
VMP – Major Project Document
Another common type of VMP document
is the major product VMP document. The VMP
major project document comprises all informa-
tion about a specific major validation project
at the site. This is significantly different than
the aforementioned site or function documents
in that it describes the respective validations
including individual protocols and results for the
major project.
For example, a new facility might include
utilities qualification, HVAC qualification, water
system qualification, equipment qualification,
manufacturing process validation, cleaning
validation of products manufactured in the new
facility, and so on – all of which would be includ-
ed in a single major document. This document
would ultimately contain the specific validation
plan, protocol, and results for utilities, HVAC,
Purified Water, equipment, manufacturing pro-
cesses, cleaning, and other validation / qual-
ification activities for the specific project. The
responsibility for this document would rest with
the site project manager for the specific project.
This VMP as described above would be a major
document likely comprising hundreds of pages.
VMP – Single Project Document
The VMP single project document com-
prises all information about a specific individual
validation project at the site. This document is
one of the sections in the above-described VMP
major project document for a given validation;
for example, the validation plan for extensions
to the Purified Water System. Literally every
validation project should have a plan – entitled
validation master plan, validation plan, validation
approach, validation strategy, or other terms.
This plan would describe:
� Statement of the validation
� What was being validated
� Why needed
� Approach to accomplish validation
� Details of work to accomplish validation
� Description of strategy and approach
� Risk analysis
� References supporting validation
� Protocols
� Approvals
The responsibility for this document
would rest with the individual project leader for
the specific project.
Validation Approval Committee
Manufacturing sites commonly have a
Validation Approval Committee (VAC) that re-
views and approves validation protocols, vali-
dation results, process and equipment changes,
and related documentation including VMP. The
VAC is a multidisciplinary group with represen-
tation from Quality Assurance, Manufacturing
Operations, Engineering, Product Technical
Support, Analytical, Microbiology, Regulatory
Affairs, Validation, and other groups as needed.
The VAC is a critical partner with the validation
function in development, review, and approval of
a VMP. The role of the VAC is extremely import-
ant. The site validation function depends on the
judgment and decisions of the VAC.
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 The VAC should consider themselves to
be a surrogate FDA (or other regulatory agency)
auditor. Whatever structure and content, the site
VAC should consider the VMP as their docu-
ment. Clarifying and unifying VMP terminology
used at a site should be a joint responsibility of
the VMP and the validation function. VMP and
other validation documents should be designed
to meeting industry and regulatory standards
and expectations.
the validation program at the manufacturing
site, the program will not be successful without
the competence, responsibility, maturity, and
full commitment of the VAC. The site validation
group and the VAC should jointly lead a site
initiative to clarify VMP terminology, content, and
application in the site, and ensure that VMP is
consistent with industry and regulatory norms
and expectations.

Final Thoughts References

The above discussion describes two FDA. Guidance for Industry. Process Validation. General
Principles and Practices. January 2011.
major categories of Validation Master Plans. The
first and more commonly used category is as
Source URL
an overview document containing fundamental
http://www.ivtnetwork.com/article/validation-master-plan-vmp-part-1-dif-
information about a site validation program. ferences-terminologycontent-and-applications
This may be structured as a single document
containing information on all functions, or may
be separated as individual function documents.
The second category describes specific
validation project plans including protocols and
results for either major validation projects or
individual validation projects. These respective
different use of the same VMP terminology
causes confusion when individuals attempt to
discuss VMP topics.
Sites should consider clarifying VMP
terminology, content, and applications, and
then developing a procedure that defines terms
used at their site. Such procedure will unify
terminology used by personnel at the site. It will
further serve to clarify terms when the site is
audited by regulatory or other outside auditors.
Preparing a lexicon will also obviate the need
to make changes in numerous site documents
such as the recent FDA change to Process
Performance Qualification (PPQ) change from
PV when new terminology is implemented.
Confusion with inconsistencies in global
regulatory documents is minimized with a site
lexicon.
The VAC has a key responsibility in the
site validation program. The VAC should consider
themselves to be a surrogate FDA auditor
when they are reviewing validation documents
including VMP. They represent the last review of
a document before FDA or other auditors review
documentation. While the validation group leads
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