Как написать эффективный мастер план по валидации

How To Write An Effective Validation
Master Plan
By Joy McElroy
A validation master plan (VMP) outlines the principles involved in the qualification of a
facility, defining the areas and systems to be validated, and provides a written program
for achieving and maintaining a qualified facility. Master plans are written to assist an
organization with validation strategies or to provide control over a specific process.
The VMP is different from a validation procedure (SOP), which describes the specific
process for performing validation activities. The VMP is beneficial for planning
purposes because it identifies anticipated resource needs and provides key input into
scheduling of project timelines. It documents the scope of the validation effort including
impacted product, processes, procedures, facilities, equipment, and utilities.
What Is A VMP?
A VMP is a document that details the way a company will operate, who has control over
the various aspects of the validation activities, and how production, quality control, and
personnel management will be directed. The VMP allows companies to agree upon and
document an overall validation strategy, which can be provided to regulators to serve as
clear justification for the validation effort. The VMP allows manufacturers to show they
are in control of their quality system and focused on quality.
Functions Of The VMP
The VMP has several functions:
 Management education – Upper management is not always aware of the

necessity for validations and qualifications. They are focused on the company’s
finances and business processes. The VMP educates management by presenting
an assessment of the potential impact of manufacturing processes on product
quality.
 Project monitoring and management – The VMP includes validation
schedules and timeline for project completion.
 Auditing the validation program – The VMP describes all activities
involved in the validation of processes and the qualification of manufacturing
equipment and utilities. It provides the facility’s approach and strategy to
validations, as well as a timeline for completion of validation activities in
accordance with criticality.
 Planning purposes – The VMP identifies anticipated resource needs and
provides key input into scheduling of project timelines.
 Documenting the scope of the validation effort – This includes impacted:
o product,
o processes,
o procedures,
o facilities,
o equipment, and
o utilities.
15 Critical Components Of A VMP
All VMPs must include the following:
1. Title page and authorization (approval signatures and dates) – The

title page must include the title, document number, and version. It must clearly
identify the necessary management approval signatures, including those from
QA.
2. Table of contents – The table of contents provides a guide to the substance of

the VMP. It should contain all the major areas of the VMP and where to find
them within the document.
3. Abbreviations and glossary – Abbreviations and glossary serve to define

technical or organizational terms that may be unfamiliar to the reader.
4. Validation plan – The VMP serves to identify what should be validated, and
where, when, how, and why the validation should be performed. The validation
plan must include a breakdown of the process into several parts and identify
which processes are critical to the quality of the product and therefore require
validation.
5. Purpose and approach to validation – The purpose provides an overview

of each process and describes the validation approach along with supporting
rationale. It needs to be concise but still detailed enough to enable end users to
quickly understand the what the document addresses.
The validation approach defines the purpose of the VMP in demonstrating the
critical equipment, systems, and processes perform as designed and intended.
The approach assures all validations will be conducted prospectively following
written and approved protocols. It addresses change control and qualification of
equipment and systems and ensures they will be conducted in a manner
consistent with policies and procedures. The approach states that specific
equipment, systems, and processes to be validated will be determined based on a
documented risk assessment.
6. Scope of validation – The scope of the VMP addresses all activities related to
equipment, utilities, processes, systems, and procedures that may impact product
quality at the manufacturing facility. It must address specific systems,
equipment, utilities, and procedures to be qualified, and processes to be validated
shall be determined based on documented risk assessment. Clearly spell out what
and who is (and is not) in the scope. All readers must have the same
understanding of the starting point and the coverage of the VMP.
7. Roles and responsibilities – This section defines the responsibilities of the

validation department for preparing validation protocols, task reports, change
control documents, and validation SOPs, and for maintenance and storage of all
validation-related documents. Manufacturing and engineering will approve the
VMP and all validation protocols, protocol deviations, change control documents,
and reports. QA will review and approve the VMP, validation protocols, task
reports, protocol deviations, change control documents, and SOPs for consistency
with cGMPs, consistency with policies and procedures, and approval to
implement.
8. Outsourced services – This section covers the selection and management of

any qualification activities or calibrations performed by an outside vendor. These
services must be clearly spelled out in the VMP.
9. Deviation management in validation – The VMP must address the

procedure for documenting deviations. Ensure it states that deviations occurring
during validation shall be documented and investigated in accordance with
procedures or as defined in validation protocols, and that corrective actions
taken, or corrective action plans, shall be reviewed and approved prior to, or
concurrent with, approval of the validation report.
10. Change control in validation – The VMP must state that all changes with
potential impact on validated systems and/or processes must be addressed by
established change management procedures.
11. Risk management principles in validation – Risk management principles

should be stated in the validation master plan as they apply to process validation,
from the design and development of the process to maintaining the validated
state of the process through its entire lifecycle.
12. Training – The VMP must state that all personnel involved in the performance
of qualification and validation activities must be trained in the tasks they will be
performing.
13. All validations – These include premises, utilities, processes, cleaning,

equipment, analytical method, computer validation, revalidation, and
qualification. Provide a general description of the facility and specifications in the
VMP. Include all the major areas included in the validation plan such as the
central plant, manufacturing areas, and material storage. Include reference
drawings or attachments as necessary, and identify critical areas of the facility,
such as GMP versus non-GMP areas. Describe manufacturing and cleaning
processes to be validated, and include descriptions of major steps and equipment
used in the process. General acceptance criteria must be met for a given piece of
equipment, system, or process to ensure that it is operating properly and meeting
its specific acceptance criteria as defined in the specific protocol for the
equipment, system, or process.
14. Validation matrix – The validation matrix should list the required validations
throughout the facility in order of criticality. By matrixing the validations, a
validation schedule can be implemented to carry out and execute the most
important validations and qualifications first.
15. References – The VMP must list documents impacting or providing guidance
for the writing and execution of validation and qualifications.
Writing The VMP
A team-writing approach for VMPs is advantageous because it ensures comprehensive

knowledge from different perspectives. Team-writing involves people from diverse parts
of the operation, which helps ensure all processes, equipment, utilities, and systems are
addressed in the VMP. Team-writing also trains trainers, the people who write the VMP.
Having participated in the in-depth decision-making about the VMP, the initiator knows
it intimately and is more likely to be an effective trainer.
When writing a VMP, keep in mind that it should be as lengthy as necessary to relay the
necessary information, and an incomplete VMP sets the organization up for failure.
Conclusion
An effectively written VMP is critical to an organization’s success as a quality

manufacturer as well as to regulatory compliance. Poorly written VMPs are the source of
numerous 483s and warning letters issued by the FDA. VMPs must be written in a
concise, to the point, and comprehensible manner. Write as if the reader has no prior
knowledge — this will result in simple, specific terms. Always write in active voice using
present-tense verbs, and never give the reader a choice by using words like “may” or
“should.” Be direct and decisive. A well-written and organized VMP will give clear
direction and instruction for avoiding deviations and ensure the manufacture of quality
products.
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How To Write An Effective Validation

Functions Of The VMP

The VMP has several functions:

 Management education – Upper management is not always aware of the

15 Critical Components Of A VMP

All VMPs must include the following:

1. Title page and authorization (approval signatures and dates) – The

2. Table of contents – The table of contents provides a guide to the substance of

3. Abbreviations and glossary – Abbreviations and glossary serve to define

5. Purpose and approach to validation – The purpose provides an overview

7. Roles and responsibilities – This section defines the responsibilities of the

8. Outsourced services – This section covers the selection and management of

9. Deviation management in validation – The VMP must address the

11. Risk management principles in validation – Risk management principles

13. All validations – These include premises, utilities, processes, cleaning,

Writing The VMP

A team-writing approach for VMPs is advantageous because it ensures comprehensive

An effectively written VMP is critical to an organization’s success as a quality

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