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Validation Master Plan: Validation Master Plan

Template

Document information, authorship and approvals

Author signs to confirm technical content
Prepared by: Job title: Signature: Date:

Subject matter expert reviewer signs to confirm technical content

Reviewed by: Job title: Signature: Date:

Quality representative signs to confirm document complies with quality management system
Authorised by: Job title: Signature: Date:

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Contents
1. Introduction 3
1.1. Validation Policy 3
1.2. Location 3
1.3. Scope 3
1.4. General Schedule 3
2. Validation Responsibilities 4
3. Site Description 5
3.1. Facility 5
3.2. Equipment 5
3.3. Process 5
4. Specific Process Considerations 7
5. Validation Requirements 7
5.1. Requirement Specification 7
5.2. Equipment Criticality & Risk Assessment 8
5.3. Equipment Qualification 10
5.4. Process & Product Validation 10
5.5. Cleaning Validation 11
5.6. Test Method Validation 11
5.7. Computer Systems Validation 12
5.8. Routine Revalidation 12
6. Acceptance Criteria 13
7. Validation Schedule 13
8. Standard Operating Procedures 13
9. Documentation 14
9.1. Validation Templates 14
9.2. Documentation Management 14
10. Change Control 15
12. Definitions 16
13. Referenced Documents 16
14. Attachments 16

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1. Introduction

1.1. Validation Policy

The validation policy is intended to convey the attitude of the company and, in particular,
senior management, to validation. It should both emphasise an intent to perform
validation where appropriate and define the relevant regulatory framework.
This section can be developed within the VMP, or extracted and expanded upon in a
stand-alone policy document.
Company Name is committed to ensure that manufacturing achieves continuous quality
outcomes, as well as compliance with all relevant regulatory requirements. Validation, in
accordance with Good Manufacturing Practice (GMP) principles, forms a key strategy in
this commitment. Validation at the site is performed in accordance with the Therapeutic
Goods Administration (TGA) code of GMP (PIC/S Guide to GMP for Medicinal Products,
PE009). The PIC/S Guide requires that:
• validation should reinforce GMP
• it should follow defined procedures
• results and conclusions be recorded
• new processes and equipment should be validated
• significant changes should be validated
• critical processes should undergo periodic revalidation to ensure ongoing capability.
All relevant aspects of GMP manufacture at the site, including facility, equipment,
computer systems, processes, test methods and cleaning require qualification and/or
validation in line with these PIC/S requirements.

1.2. Location
This Validation Master Plan (VMP) describes the validation requirements for the Company
Name Validation Master Plan Template located at Company Address.
The company address listed under 1.2 should be the full site address, including street
number. Other references to company address may reference the city name only.

1.3. Scope
This section should describe the limitations of the VMP – The scope should be all inclusive
within the VMP boundaries (the site, facility or other defining feature of the VMP).
All relevant aspects of GMP manufacture at the Company Address site, including facility,
equipment, computer systems, processes, test methods and cleaning are subject to
qualification and/or validation in accordance with this VMP.

1.4. General Schedule

When a VMP is first prepared, there is usually a specific trigger and it’s usually
accompanied by a body of required validation work. On first creation, this general
schedule section should describe that initial body of work in terms of general timing.

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The VMP will be regularly updated, this section should always reflect a broad description
of the timing and activities of known upcoming validation work, and a brief summary of
historic work completed under the VMP.
The construction and commissioning for the Company Address site is to occur during the
first 3 quarters of 2011. The bulk of the validation effort is expected to take place in the
second half of 2011. Some recurrent validation and qualification work will be ongoing for
the life of the facility.

2. Validation Responsibilities
This section should define in detail the breakdown of validation responsibilities. In smaller
companies, this table may include very few entries (eg. quality, operations, delegated
staff). In larger companies, the table is likely to include many other roles (subordinate QA
staff, dedicated validation staff, production, engineering, regulatory affairs, metrology, QC
staff, etc.). It may also be useful to include a validation department organisational chart
for very large organisations.
Validation at Company Name is considered a function of the Quality Department. The Site
Quality Manager has overall responsibility for the validation program. Specific
responsibilities are allocated in accordance with the table below:

Role Responsibilities

Site Quality Manager Ensure all GMP critical equipment and processes are validated.
Prepare or delegate preparation of validation protocols and reports.
Review completed validation documentation.
Participate in and approve the resolution of non-conformances.
Review existing validation protocols.
Maintain this Validation Master Plan.
Notify relevant personnel when validation is due.
Train staff on validation protocols and procedures.
Custodian of all validation and associated documents and tooversee
validation studies.

Operations Manager Allocate suitably trained personnel to perform activities during

validation studies.
Provide technical advice to support the preparation and execution of
validation protocols.
Participate in the resolution of non-conformances.
Implement corrective actions arising from validation exercises

Staff delegated to Prepare validation plans, protocols and reports as directed by the
validation tasks Quality Manager
Perform validation activities as directed by the Production Manager.
Advise management if their level of training in and understanding of
validation tasks is not appropriate to perform them.

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Role Responsibilities

Validation Act as delegate for any of the above roles as appropriate and
consultants commensurate with the experience and skills of the consultant.

3. Site Description
It is important to define the facility, equipment and processes which the master plan
covers. This is not intended to be an itemised list of validatable items, but rather gives an
overview of the type of manufacture conducted

3.1. Facility
Company Name manufactures aseptically prepared, sterile injectables, terminally sterilised
infusion bags, non-sterile powders, creams and ointments, capsules and tablets at the
Company Address facility. There are three distinct manufacturing areas (liquids, creams
and powders), each featuring several interconnected clean rooms of varying grades. Each
manufacturing area provides a background environment suitable for the operations
performed.
All three areas are serviced by a common operations room and store area. In addition to
general warehouse space, the store area includes a 2-8°C cold room, and a -20°C freezer.
Personnel flow is common into the store and operations rooms, however, entry to the
manufacturing areas is by a dedicated change/airlock. Materials flow is facilitated by pass
through mechanisms between each area of differing grade.
Refer to drawing no. XXXXXX for a graphical representation of the facility layout.

3.2. Equipment
The Company Address facility features several key items of equipment to facilitate the
manufacture of product. The key items of equipment include:
• Laminar flow and cytotoxic cabinets for aseptic manipulations
• Aseptic liquid vial filling/capping machine
• Bag filler
• Cream filler
• Mixing tanks
• Homogeniser
• Powder mixer
• Powder filler
• Process autoclave
• Tablet press
• Encapsulator
• Blister packer

3.3. Process
If the company’s processing is similar or the same for all products, it is appropriate to
summarise the basic steps here. If there are various processing techniques, processing
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instructions should be referenced here instead. These may be specific product

manufacturing instructions, or processing step SOPs if available.
Company Name prepares a wide range of products using various processes. The key
processes are referenced below:
• Dispensing
• Gowning
• Mixing
• Filling
• Tabletting
• Encapsulation
• Freeze drying
• Container closure
• Quarantine and release
OR if the company has one basic process, a table such as this may be more appropriate:
Step Description

Non-sterile Personnel entering the store and operations areas gown appropriately for
gowning the work to be conducted

An order is verified and batch documents and labels generated and

Receive order
checked

Personnel in the operations room collect starting materials for the order
Collect Starting
into a batch tote bin according to the batch document and transfer to the
Materials
preparation room

Sterile
Operators gown for aseptic processing in the C/B grade airlocks.
Gowning

Decontaminate Personnel in the preparation room decontaminate the starting materials

starting with biocidal agent and transfer them to the manufacturing suites via the
materials pass through hatch

Set-up Personnel in the manufacturing suite aseptically prepare the cytotoxic

preparation safety cabinet or laminar flow cabinet – start-of-worksession clean,
process consumables require (needles, syringes, diluent etc).

Prepare in
accordance Personnel in the manufacturing suite aseptically prepare or manufacture?
with batch the product in the cytotoxic safety cabinet or laminar flow cabinet
documents

Label finished Personnel in the manufacturing suite transfer the finished product to the
product dedicated cabinet trolley (move from A to B) and label the product.

The finished product and batch documents are transferred from the
Transfer to
manufacturing suite to a quarantine bench within the operations room via
quarantine
the pass-through hatch prior to inspection and release.

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Step Description

The product is inspected and released according to quality and product

Inspection and
requirements before being packed and transferred to the released area
release
within the double-door pass-through refrigerator.

Prepare for Personnel in the store area pack the labelled product in shippers and
dispatch complete transit documentation

4. Specific Process Considerations

This section is intended to highlight specific or unusual issues with the company’s
processes which need to be addressed.
Product development and stability trials have shown that Product A is sensitive to
temperatures above 8°C. After formulation, it has been determined that the product has a
maximum period of 16 hours at 25°C before product degradation may compromise the
shelf life (refer development report XXXX). As a result, the process has been developed
such that post formulation filling to cold storage quarantine must occur within 8 hours.
This time allowance will be a major focus of validation efforts.
Process simulations are required for all aseptic processes.
Products X, Y and Z are prone to de-mixing when mixed for extended periods (refer
development report XXXX). Validations will define mixing time ranges for all powder
products.

5. Validation Requirements

5.1. Requirement Specification

5.1.1. User Requirement Specification
User Requirement Specification (URS) defines, clearly and precisely, what Company Name
requires of a system or equipment. It should define the broad compliance, operational
and processing requirements, as well as constraints and life-cycle requirements.
URS is required for all new GMP equipment items requiring validation at Company Name.
The specification should be developed, even if it is retrospective to equipment order, as it
aids in defining qualification requirements. Refer to SOPXXX- Validation for further
information.
5.1.2. Functional Specification
Functional Specification (FS) defines what the equipment should do and what functions
are to be provided in a final equipment design.
FS is optional at Company Name, but is recommended for bespoke equipment or
equipment where Company Name has significant customisation requirements. FS is
usually prepared by the supplier and reviewed and approved by Company Name.
FS documents should be based on Company Name generated URS documents.

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5.1.3. Design Specification

Design Specification (DS) is the detailed description of the equipment design and should
contain sufficient detail for the system to built and maintained.
DS is optional at Company Name, but is recommended for bespoke equipment or
equipment where Company Name has significant customisation requirements. Like FS, DS
is usually prepared by the supplier and reviewed and approved by Company Name.
DS documents should be based on Company Name generated URS and prior approved FS
documents.

5.2. Equipment Criticality & Risk Assessment

Equipment used for GMP purposes at the site will be subject to a criticality and risk
assessment to determine the extent of qualification required. Equipment shall be assessed
for criticality according to its designated impact and risk priority.
The criticality and risk assessment shall be performed as part of User Requirement
Specification in accordance with SOPXXX – Criticality & Risk Assessment for Validation.
5.2.1. Impact
The impact of equipment on product shall be categorised as direct, indirect, safety or no
impact, as defined below:
Direct impact – Equipment which is product contact, or which controls or maintains a
critical process parameter, or both
Indirect impact – Equipment which is not product contact, but which has an impact on
the performance or operation of direct impact equipment, or which is essential to meeting
the requirements of a GMP compliant process
Safety impact – Equipment which is not product contact, does not impact on the
performance or operation of direct or indirect impact equipment and whose primary
function is a safety requirement for operators during GMP manufacture.
No impact – Equipment which is not product contact, does not impact on the
performance or operation of direct or indirect impact equipment, is not safety equipment
and is not essential to meeting the requirements of a GMP compliant process.
Some examples of equipment with typical impact categorisation are provided in the table
below. This table is intended to be indicative only. Each item of equipment should be
assessed for impact individually and the findings justified in writing, regardless of the
categorisation in this table:

Equipment Examples

Direct Impact Indirect Impact Safety Impact No Impact

mixing tanks raw material and Toxic gas detectors pipettes

consumable
product transfer Dust extraction trolleys
refrigerators and
pumps
freezers Safety barriers scissors/clamps
laminar flow and
Unfiltered HVAC Emergency stops retort stands
safety cabinets
systems
Personnel protection manual cleaning
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Equipment Examples

Direct Impact Indirect Impact Safety Impact No Impact

product storage most laboratory equipment equipment (non-
refrigerators and equipment product contact
Fire suppression
freezers surfaces)
production balances systems
filling equipment
centrifuges
autoclaves
automated cleaning
process water equipment
generators
Filtered HVAC systems

5.2.2. Assessed Risk

Each URS (refer Section 5.1.1) contains a series of requirements which have various
levels of risk to product quality. At development of URS, each requirement shall be
assessed for risk and categorised in accordance with SOPXXX – Criticality & Risk
Assessment for Validation.
Each requirement will subsequently be assigned a risk priority of High, Medium or Low.
5.2.3. Qualification Assessment
Once the impact and risk priority of equipment has been resolved, the following table
should be used to determine the minimum extent of qualification work required:

Highest Rated Risk Priority in URS

Impact High Medium Low

Direct Impact IQ, OQ, PQ IQ, OQ, (PQ) IQ, (OQ)

Indirect Impact IQ, OQ, (PQ) IQ, (OQ) (IQ)

Safety Impact IQ, (OQ) (IQ) Not Required

No Impact Not Possible Not Possible Not Required

Where a qualification level is bracketed in the table above, the testing is optional based
on assessment. A decision should be made on a case-by-case basis as to the benefit of
such testing to product quality, personnel safety and/or process characterisation. This
decision should be justified in writing in relevant plans or protocols for the qualification
project.
In addition to the guidance table above, the risk priorities assigned to each user
requirement shall be used to determine the type and level of testing required during
qualification to demonstrate mitigation of the risk.

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5.3. Equipment Qualification

5.3.1. General
All equipment performing a GMP function at the site shall be subject to equipment
qualification. Qualification shall be categorised in accordance with the following industry
standard terminology:

Qualification Phase Purpose

Design Qualification Verifies the final design against the user, functional and/or design
(DQ) specifications to ensure that all specified design elements have been
included and that the design meets the relevant regulatory and
statutory requirements.

Installation Verifies that the equipment/system/process is installed correctly,

Qualification (IQ) supplied as specified, integrated into the site calibration and
maintenance systems and available for use.

Operational Verifies that the equipment/system/process is operating correctly,

Qualification (OQ) compliant with Company Name’s functionality requirements and
integrated into the site training systems and QMS.

Performance Verifies that the equipment/system/process is continuously meeting

Qualification (PQ) Company Name’s performance criteria for routine use and
performing adequately for routine use in commercial production.

The extent of qualification required for each equipment item shall be determined by the
criticality and risk assessment described in section 5.2. Equipment shall not be used for
GMP purposes until the completion of the assessment and its recommended qualification
steps.
5.3.2. GMP Equipment
A list of equipment which has undergone, or is planned to undergo criticality assessment
and qualification can be found in the Validation Schedule (refer to Section 7 and
Attachment 1).

5.4. Process & Product Validation

5.4.1. General
All products and processes requiring validation shall be subject to a validation plan (either
a stand-alone document, or incorporated in the protocol), which will determine the
appropriate method and extent of trials based on risk (refer SOPXXX – Criticality & Risk
Assessment for Validation). Typically, no less than three consecutive, successful trials will
be required to demonstrate a valid process.
Statistical methods, as well as industry best practices should be employed as part of the
risk and criticality assessments.
5.4.2. Process Details
It may be useful to list all processes subject to process validation by SOP reference. The
example text gives an idea of what sort of processes are expected

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Process validation involves validation of specific GMP critical manufacturing processes

defined within operating procedures.
The following processes are subject to process validation at Company Name:
• aseptic processes
• visual inspection processes (both manual and automatic)
• gowning procedures for aseptic processing
• terminal sterilisation processes
• packaging
• transport
5.4.3. Product Details
Product validation involves validation of the manufacturing process defined by
manufacturing instructions.
The following products are subject to process validation at Company Name:
• MBRXXX – Product A
• MBRXXX – Product B
• MBRXXX – Product C

5.5. Cleaning Validation

All cleaning and sanitation procedures relating to product contact equipment, or those
necessary to maintain environmental classifications are required to be validated. Such
procedures may include, but are not limited to:
• Equipment Clean-In-Place (CIP) procedures
• Manual equipment cleaning procedures
• Facility cleaning procedures
Cleaning procedures may be validated on a “worst case” basis, where contaminants, with
scientific justification, may be grouped together and the validation performed on one or
two worst case contaminants.
Worst case contaminants shall be determined through assessment of toxicity and
solubility/cleanability and justified in cleaning validation plans and/or protocols.
Introduction of new products or other potential contaminants shall be assessed to
consider their impact on the validated state of cleaning procedures

5.6. Test Method Validation

Some companies contract out all test methods. If so, test methods should still be
validated and the VMP explain the company’s policy in relation to responsibilities.
All test methods used to produce results for inclusion in GMP documentation for
registered products should be validated. Such methods may include, but are not
necessarily limited to:
• Test methods (pharmacopoeial and non-pharmacopoeial) for finished product testing
• Test methods for raw material and consumables testing
• Test methods used for stability programs

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• Test methods for In-process checks

Both chemical and microbiological test methods should be validated.

5.7. Computer Systems Validation

If the company has no GMP computer systems, this should be stated here, but a
statement as to company policy for potential future systems should also be present.
All computer systems performing critical GMP functions are required to be validated. Such
systems may include, but are not limited to:
• PLC and other automated control systems for critical equipment and processes
• Material / Enterprise Requirements Planning Systems
• Spreadsheets / databases used to make GMP decisions.
Any computer systems performing GMP functions at the site shall be subject to
validation as required by Annex 11 of the PIC/S Guide to Good Manufacturing Practice.
Where possible, Company Name intends to perform computer systems validation in
accordance with Good Automated Manufacturing Practice (GAMP), as currently defined in
GAMP 5.
Currently, the environmental monitoring system is the only computer system on site
subject to validation. Refer to Attachment 1 for testing details and scheduling.

5.8. Routine Revalidation

Routine revalidation is the scheduled re-testing and certifying of equipment, products,
procedures or methods as required by assessment.
Company Name performs routine revalidation on sterilisation processes, temperature
mapped zones and environmentally classified facilities and equipment.
The period between revalidation is defined below:

Validation Type Revalidation Frequency

Aseptic process simulation 6 months

Depyrogenation and terminal sterilisation 12 months

processes

Room temperature controlled storage 24 months

Non-room temperature controlled storage 12 months

Stability chambers 24 months

Grade A environmental zones and cabinets 6 months

Room classifications (below Grade A) 12 months

Other items may be considered for routine revalidation if recommended as a result of

initial validation outcomes.

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All other validations and qualifications are performed once and considered current until
assessed otherwise through quality risk management processes, including change control,
annual review and CAPA.

6. Acceptance Criteria
Acceptance criteria are the fundamental component of each validation or qualification
protocol. Each protocol must include acceptance criteria by which the success or failure of
the exercise can be assessed.
The following guidelines should be implemented when determining acceptance criteria:
• They must be measurable by means of observation, a traceable reference standard
instrument or test method
• They should demonstrate an appropriate level of reliability and accuracy
• They should, where possible and appropriate, be derived from user and/or vendor
defined requirements and specifications
• They should, where possible, be derived from industry recognised specifications or
targets.
• Where it is not possible to derive from industry recognised specifications or targets,
the suitability of the criterion must be justified in the protocol.
• They must be clearly defined, unambiguous and readily assessable on completion of
testing.

7. Validation Schedule
A schedule of validation activities is provided as Attachment 1 to this document. This
schedule is intended to be reviewed at least every three months and updated to reflect
the current status of validation activities on site.
The schedule lists all equipment qualification, process, test method and computer systems
validation required for the site. It provides current status, estimated completion dates and
explanations for any overdue work.

8. Standard Operating Procedures

The following standard operating procedures are available for the preparation and
execution of validation work at the site:
Examples of SOPs which may relate to validation below. Add or delete as necessary
Document No. Title

SOPXXX Validation

SOPXXX Equipment Calibration & Maintenance

SOPXXX Media Fill Trials

SOPXXX Criticality & Risk Assessment for Validation

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9. Documentation

9.1. Validation Templates

Validation templates are available to promote consistency of format and approach to
qualification and validation exercises. Use of the templates is encouraged but not
mandatory. Internally prepared documents using an alternative document format should
cover the primary headings listed in the templates.
Alternative contents/formats provided by a third party (such as an equipment supplier)
are acceptable, provided that such protocols and reports are approved by the Quality
Manager (or delegate) and meet all applicable regulatory requirements.
The following internal templates are available for general validation purposes:
• Validation Master Plan
• User Requirements Specification
• Validation Project Plan
• Equipment Validation Plan
• Process Validation Plan
• Installation Qualification Protocol
• Operational Qualification Protocol
• Performance Qualification Protocol
• Process Validation Protocol
• Validation Summary Report
• Exception Report

There is also a suite of templates available and dedicated to computers systems

validation.

9.2. Documentation Management

There are two general approaches to validation document management:
• Validation documents may be incorporated entirely into the site quality
management system, and documents be issued, approved and controlled in the
same way that SOPs and other quality documents are controlled. For this type of
system, this section should refer heavily to the existing QMS procedures
• In many cases, it may be advantageous for validation to have its own
documentation management system, controlled by the validation department. This
ensures that the highest level of control over document delivery can be maintained
by validation, which usually results in faster approvals and other efficiencies. The
example text below is aimed at this type of system
Validation documentation management is performed in accordance with SOPXXX –
Validation. The sections below summarise the procedure.
9.2.1. Document Control
Validation documents are initiated by the Validation Manager or delegate, who updates
the REGXXX Validation Document Register, and issues sequential document numbers, in
accordance with the document type (see Section 9.2.2).
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The Validation Manager or delegate determines the appropriate level of approval for each
validation document. Once approved, the Validation Manager or delegate stores the
signed hard copy and makes copies for execution/reference as required.
If validation documents require revision, the document is updated to the next revision
number and approved by the same (or higher) level of authority as for the original
document.
Superseded documents are not archived, but filed in the project file as a record of
validation activity.
9.2.2. Document Identification
Example of an identification system below. Text should be modified as necessary.
Validation document numbers take the form of XXX-123, where ‘XXX’ indicates a 2 or 3
letter indicator of the type of document, and ‘123’ is the sequential number for that
document type, commencing at 001. The following document types are available:
• VMP – Validation Master Plan
• VPP – Validation Project Plan
• URS – User Requirements Specification
• VP – Validation Plan
• DR – Design Review
• IQ – Installation Qualification
• OQ – Operational Qualification
• IOQ – Installation and Operational Qualification
• PQ – Performance Qualification
• OPQ – Operational and Performance Qualification
• PV – Process Validation Protocol
• VSR – Validation Summary Report
• ER – Exception Report

10. Change Control

All changes to validated equipment, systems, processes and methods are subject to
change control, in accordance with SOPXXX – Change Control. For such changes, the
effect of a change on validated status must be considered and documented using FRMXXX
- Change Control Form. It is the responsibility of the representatives of the Change
Control Committee to ensure that changes either do not affect the validated status, or
that appropriate documentation and testing is included with the change to ensure that a
new validated state can be established.
Note: Changes to validation documents or revisions are not subject to document change
control as per SOPXXX – Change Control. Refer to Section 9.2.1 for details.

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12. Definitions
This section contains definition of any terms that may be unfamiliar to the reader.

Term/Abbreviation Definition

13. Referenced Documents

The following documents may assist in the understanding and execution of this plan

Document Number Document title

PE009-8 PIC/S Guide to GMP for Medicinal Products, including Annexes

14. Attachments
Attachment Title
Number

1 Validation Schedule

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Document Information
Revision History
Revision Modified by Change Description of Change
Control No.
01

Complete the above fields for each revision of this document. Ensure that there is
sufficient description of changes so that the change history of this document can be
followed. Additional columns can be added to include document/change tracking numbers
generated by your company’s systems if required (eg. change control).

Associated forms and procedures

Doc. No. Document Title

List all controlled procedural documents referenced in this document (for example,
policies, procedures, forms, lists, work/operator instructions

Associated records
Doc. No. Document Title

List all other referenced records in this document. For example, regulatory documents, in-
house controlled documents (such as batch record forms, reports, methods, protocols),
compliance standards etc.

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