Pharmaceutics

1. Validation Master Plan
Guided By:
Dr. Hetal Patel
Assistant Professor
Deaprtment of Pharmaceutics
Presented By:
Pinal Patel
(202204100410015)
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INTRODUCTION
Validation master plan has all details about the all validation programs of the manufacturing facility. It has the summary
of the validation strategy of the facility including the design validation, IQ, PQ, OQ, cleaning validation, process validation
and computerized system validation.
A Validation Master Plan (also referred to as the VMP) is a document which outlines the principles tied to the
qualification of a certain facility, defining the systems and areas which need validation and provides a written guideline
on how to achieve and then maintain a qualified facility.
VMP is basically a summary of the validation strategy. It is a crucial segment of Good Manufacturing Practice regulated
pharmaceutical practice because it supports a structural approach to GMP validation projects.

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Purpose
The purpose of a VMP document is to show that all systems, equipment and processes work as intended and to have a
validation based on written and already approved protocols. They are sometimes named after their functional areas such
as a Software Master Plan or a Site Validation Master Plan.
Importance
Having a VMP is of crucial importance for a facility, as Food and Drug Administration inspectors look at Validation Master
Plans in order to see whether a certain facility has an organized and well-thought—out validation strategy. That is why a
VMP should contain logical reasoning behind every included or excluded system associated with a validation project. The
reasoning, of course, has to be based on risk assessment and have good grounds.
The current standard for writing a VMP is GAMP 5. GAMP (short for Good Automated Manufacturing Standard) is a
pharmaceutical industry guide specially designed for those involved in the manufacture or use of automated systems.
One of the core principles of GAMP is that quality should never be tested on a batch of products; it should rather be
incorporated into each and every step of the manufacturing process.

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How to write validation protocol?
Every Validation Master Plan should include:
. All validation activities (currently performed, future ones and those already completed)— Schedule and priority of
validation activities
. Description of the validation policy of the company.
. An overview of the scope of work, as well as a description of products, facilities and processes
. Copies or details of related VMPs, relevant documents/reports/protocols- Personnel responsible for plan approval,
review or reference tracking systems.
. Change control
. Appendices or references to any planned validation training programs.
Validation Master Plan should be simple to navigate and understand and therefore split into different sections.

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How to write validation protocol?
Every Validation Master Plan should include:
. All validation activities (currently performed, future ones and those already completed)— Schedule and priority of
validation activities
. Description of the validation policy of the company.
. An overview of the scope of work, as well as a description of products, facilities and processes
. Copies or details of related VMPs, relevant documents/reports/protocols- Personnel responsible for plan approval,
review or reference tracking systems.
. Change control
. Appendices or references to any planned validation training programs.
Validation Master Plan should be simple to navigate and understand and therefore split into different sections.

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Who perform the VMP?
• Validation manager
• Member from Quality Assurance department
• Member from production
• Member from Engineering department
• Member from QC lab
• Member from HVAC department
• Member from product development lab

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Content of Validation Master Plan
• Introduction
• Methodology
• Qualification:
o Design qualification (DQ)
o Installation qualification (IQ)
o Operational qualification (OQ)
o Performance qualification (PQ)
• Personnel
• Schedule
• Preventive maintenance
• Change control
• Documentation

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INTRODUCTION
This section is written as an introduction to the validation process and the facility, and it is intended to set the scene
The introduction of a VMP should include following details:
o a description of facility, its premises and equipment, and its purpose intention and scope of validation
o other relevant site policies and plans, like factory or corporate policy statements on GMP,QA etc.
METHODOLOGY
This section should address the predetermined requirements by identifying the standards that are to be applied to the
facility.
These are then used in the development of the acceptance criteria that are used to judge the validation.
It also involves planning and execution of documents such as, protocols, records, reports, or other. The standard will
involve three elements:
• Regulatory and guidance documents
• National standards
• Company standards

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PERSONNEL
• The CFR 21 states “ Each person engaged in and each person responsible for supervising the manufacture,
processing, packaging or holding a drug product shall have the education, training, and experience, or a combination
thereof, to enable that person to perform the assigned functions.”
• The VMP should lay down the principles for personnel requirements. It must address the aspects like; experience of
personnel (written biographies or CV), in-house training reports, etc.,
• Documenting the training is essential and is a requisite of the GMPs.
SCHEDULE:
• The work program is essential and should be prepared at an early stage.
• A good plan will contain all the necessary features which are to be considered during execution of a plan and
determines the control of the project.
• It ensures that all the personnel involved in the VMP are not only aware of the engineering targets, but also the
validation targets.

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PREVENTATIVE MAINTENANCE
This is the responsibility of Site maintenance and Operation dept. This activity should be performed during the design
phase, and the documentation required should be, included in the requisition.
DOCUMENTATION
For effective use of documents they should be designed and prepared with utmost care.
As per SOP it shall:
• Have a clear title
• Have a particular identification number
• Have the effective date
• Be approved by authorized persons.
APPENDICES
The appendix is mostly used VMP to hold the information of type of documents and formats that will be used in the
execution stage

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CHANGE CONTROL
• A strict change control procedure should be followed as per the standard procedure.
• All changes shall be formally requested, documented and accepted by the representatives of quality assurance.
• Change control format comprises of the following:
o Detail of change requested
o Reason for proposed change
o Impact and risk assessment of change.

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REFERENCES
• U.S. Food and drug administration, 21CFR 601.12 (a), April 1, 2000.
• Pandey m.a.g. Validation technology in pharmaceutical industry. A Review Journal of drug discovery
and development -2018,2(1), (30-34). • B.t. Loftus and Nash, pharmaceutical process validation,
drugs and pharmaceutical sciences, vol-129, 3
• https://www.pharmaguideline.com/2019/03/how-to-write-validation-master-plan.html