What is Validation Master Plan, Its Content & Regulatory Requirement in Computer System Validation?
What is Validation Master Plan & Is your auditors happy to seeing validation plans?
In Earlier post we understood How to Conduct a GAP Assessment in Computer System Validation process.
Now
in this article we are going to understand What
is Validation Master Plan, Its content & Regulatory requirement in
Computer system validation?
What
is Validation Master Plan?
EU
GMP Vol. 4 Annex 15 says: “The key elements of a validation program
should be clearly defined and documented in a validation master plan (VMP) or
equivalent documents.”
Validation
Master Plan helps give sense and organization to your validation efforts, and
an understanding of how it supports the goals of your facility. It makes
auditors happy because they are used to seeing validation plans.
Top
management is not always aware of the real requirements for validations and
qualifications. They generally focus on finances and business processes. The
Validation Master Plan helps educate management by presenting a summary
assessment of what it will take to get the job done.
The Validation Master Plan also
referenced as "VMP" is one of the key documents in the GMP (Good
manufacturing practice) regulated pharmaceutical industry.
According to
GMP requirements, manufacturers should plan qualification and validation within
a product lifecycle. Any changes in the facilities, equipment, utilities, and
process affecting product quality should be formally documented and the impact
on validated status should be assessed.
VMP
is a roadmap of validation activity like facility qualification and also define
system and area to be validated. Critical computerized systems should be
validated.
The Validation Master Plan is a summary of validation strategy. The purpose of the Validation Master Plan is to document the compliance requirements for the site and to ensure that sufficient resources are available for validation projects.
The
validation master plan is a document where key elements of the
qualification and validation program are identified and documented.
VMP
justifies the strategy, documenting the necessary program. It’s a “high level”
document which provides a written program to ensure a continuing state of
validation. We can say VMP is achieving and maintaining qualified facility.
All
Validation program is mention in VMP. In simple language we can describe
the major element of “Validation program”-
Validation
Master Plans should be approved by the head of Site Quality, plus other senior
department heads as appropriate. Senior management approval is necessary for
Validation Master Plans because their support is essential for the success of
the plan.
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The
validation Master Plan helps to Determine:
•
Systems, equipment, methods, facilities, etc., that are in the scope
of the plan
•
List of tests
•
Control points
•
Sampling frequency and location
•
Frequency of the re-qualification
Validation
Master Plan must Include:
•
Qualification and validation policy
•
General validation risk mitigation strategy
•
A list of all validation activities & any parallel Validation
Plans
•
A list of personnel responsible for the VMP, SOPs and protocols
•
A list relevant validation reports and documents
•
A list of personnel (roles) who provide approval
•
Current validation status for the systems within the project scope
•
The organizational structure including roles and responsibilities for
conducting qualification and validation
•
Summary of the facilities, equipment, systems, processes on-site and
the qualification and validation status
•
Compliance requirements for validation, including how the validated
state will be maintained
•
Schedule of validation activities
•
Change control and deviation management for qualification and
validation
•
Guidance on developing acceptance criteria
•
References to existing documents
•
The qualification and validation strategy, including re-qualification
•
Required validation Deliverable
Content
of Validation Master Plan:
•
Title page and authorization (approval signatures and dates)
•
Table of contents
•
Abbreviations and glossary
•
Validation policy
•
Philosophy, intention, and approach to validation
•
Roles and responsibilities of relevant personnel
•
Resources to ensure validation is done
•
Outsourced services (selection, qualification, management through life
cycle)
•
Deviation management
•
Change control
•
Risk management principles
•
Training
•
Scope of validation
•
Documentation required in qualification and validation such as
procedures, certificates, protocols, and reports
•
Premises qualification
•
Utilities qualification
•
Equipment qualification
•
Process validation
•
Cleaning validation
•
Personnel qualification such as analyst qualification
•
Analytical method validation
•
Computerized system validation
•
Establishing acceptance criteria
•
Life-cycle management including retirement policy
•
Re-qualification and Revalidation
•
Relationship with other quality management elements
•
Validation matrix
•
References
“Trust but Verify “ Ronald Reagan
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