What Is A Validation Master Plan
What Is A Validation Master Plan
What Is A Validation Master Plan
-It should define the validation philosophy and organisation for the project.
-Additionally, clients may decide this is a useful place for documenting some of
the pre-qualification activities.
*This section gives an overview of the sections of a validation master plan and
what should be included in these sections.
-Introduction
-Aim
-Responsibilities
The Introduction - explains what the project is, where it occurs and the reason it
is required. It should clearly state the central aim in the project and focus on a
commitment to cGMP and validation.
The Aim -should include notification of the project team and regulatory
authorities about the project, facility layout, utilities, equipment, systems and the
processes that the facility is designed to house. Also, the aims should state the
approach that's to be taken on the project and lay out the assorted roles and
responsibilities involved.
The Responsibilities- this section should introduce the project team members
(by job title) and will define the role each member will play in the project.
The Description - this section should avoid details, especially engineering detail
and it should focus on highlighting cGMP related aspects. Some of the elements
contained in the Description section are described below:
1. Facility
This is a key component of the VMP. It should explain the rationale for:
-Layout
-Personnel Flow
-Equipment Flow
-Area Classifications
-Finishes
2. Utilities
3. Equipment
This section should list only the KEY equipment to be used in the facility. It
should label each piece of equipment as critical and non-critical and
explain the difference between these labels. **Critical equipment is
equipment that plays a direct role in manufacturing the product.
It should identify which equipment is new and which is pre-existing
(legendry).
It should explain the role of the equipment, cycles, critical parameters and
other pertinent information.
It should address the suitability of the materials of construction/ finishes of
any product contact parts.
5. Computer Systems
6. Validation Strategy
This section explains the rationale for the approach to validate the facility
It also introduces any specific company policies and procedures
It explains every qualification process and describes the activities required
for each one
This section explains the difference between critical and non-critical
systems
It compiles a matrix of systems to identify the qualifications that need to be
applied to each
This section also describes the methods of documenting various validation
activities. It includes flow charts, when appropriate, to assist the reader
It explains the format and content. It gives instructions for the preparation
of documents including who is responsible, when they will be drawn up
and gives instructions for their review and approval
It describes a method for numbering documents
This section explains how various document types are controlled and how
changes will be managed
Validation Assurance Systems
Validation Report
The validation master plan clearly states that the OVERALL VALIDATION
REPORT is to be written at the completion of the project. This overall
validation report will summarize all of the DQ, IQ, OQ, PQ Computer
Systems Validation work and other important information.
A FMECA is central to the risk assessment and is carried out on each individual
part of the process. This will list the following for each activity:
Risk Analysis
Risk analysis should be conducted via cross functional team meetings covering
the following four criteria:
Probability - the likelihood that a failure will occur in the process. This
parameter is rated on a scale as follows:
3. High - will occur several times during the lifetime of the system
Risk Priority
The risk priority is estimated on the likelihood of detection in conjunction with the
risk class and can be used to define the priority for further mitigating risks.
Following implementation of mitigations, the revised risk priority should be low in
order to proceed with that activity in the process.
Most important in this assessment are risk priority at medium. Since it is not low
potential risk mitigations are required. Execution of this agreed risk mitigation
results in a revised risk priority of Low. This means no further work is required on
this parameter prior to actual validation runs.