The document outlines a validation master plan (VMP) essential for ensuring compliance with good manufacturing practices in pharmaceuticals. It describes validation as a quality assurance process that guarantees the safety, efficacy, and quality of products by validating critical steps in manufacturing. The VMP serves as a comprehensive guide to document the manufacturer's validation activities, including methodologies, qualifications, personnel responsibilities, and change control processes.

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K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1
Validation Master Plan
A Seminar as a part of curricular requirement
for I year M.Pharm II Semester
Presented by
G.HIMABINDU (Reg.no:20L81S0703)
Pharmaceutical analysis
Under the guidance of
Dr. P.Ramalingam M.Pharm, Ph.D.
Director – R&D Division,
Professor of pharmaceutical analysis and medical chemisry
President – IPA local branch - anantapuramu

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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2
• Validation
• Validation master plan
• Who perform the validation master plan
• Contents of validation master plan
Contents

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Validation
• Validation is an essential part of Good manufacturing
practices(GMP).
• It is therefore, an element of quality assurance programme
associated with particular product or process.
• The basic principles of quality assurance have as their goal the
production of products that are fit for their intended use.

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• Quality, safety, efficacy must be designed and can be built in to the
product.
• Quality cannot be inspected or tested in to the product.
• Each critical step of manufacturing process must be validated.
• The concept of validation was first proposed by two Food and drug
administration officials.
• Tedbyers and Bud loftus, in 1979 in USA to improve the quality
of pharmaceuticals.
Principles as follows:

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US-FDA :
Confirmation by examination and Provision of objective evidence that
the particular requirement for a specific intended use can be
consistently fulfilled.
WHO:
Validation is defined as the documented evidence that provides high
degree assurance that specific method or process or systems will
consistently produce results meeting the predetermined acceptance
criteria.
Definitions

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Schedule M
• The defined process, materials and equipment specified shall be
demonstrated yield a product consistently of the required quality.
US FDA included Some form of validation around 1970s (process
validation under 21 CFR Parts 210 and 211).

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Definition:
• The VMP is a high-level document that establishes an umbrella
validation plan for the entire project and summarizes the
manufacturer’s overall philosophy and approach, to be used for
establishing performance adequacy.
• It provides information on the manufacturer’s validation work
programme and defines details of and time scales for the validation
work to be performed, including a statement of the responsibilities
of those implementing the plan.
Validation Master Plan

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VMP

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K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Key elements:
• A validation policy
• Organizational structure of validation activities
• Summary of facilities, systems, equipment, process validated and
to be validated.
• Documentation format (e.g. Protocol and report format)
• Planning and scheduling
• Change control
• References to existing documents.

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Who perform the VMP?
Members:
• Validation manager,
• Quality Assurance department
• Member from production
• Member from Engineering (utilities)
• Member from QC lab
• Member from HVAC department
• Member from product development lab

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V
M
O
D
E
L

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• Introduction
• Methodology
• Qualification:
 Design qualification (DQ)
 Installation qualification (IQ)
 Operational qualification (OQ)
 Performance qualification (PQ)
• Personnel
• Schedule
• Preventive maintenance
• Change control
• Documentation
Contents of VMP:

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The introduction of a VMP should include following details:
• A description of facility, its premises and equipment, and its purpose.
• Intension and scope of validation.
• Other relevant site policies and plans, like factory or corporate policy
statements on GMP, QA, etc.,
Introduction:

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• The VMP document serves as a guide with company’s
overall approach towards performing validation and
qualification activities, in accordance with:
 WHO
 cGMP
 cGLP
Objective:

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Validation master plan ensures that:
• To demonstrate that the facility is capable of meeting process or
product parameters in repeatable manner.
• The critical programs for utilities, qualification, process
validation have been established, in accordance with the product
requirements.

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• This section should address the predetermined requirements by
identifying the standards that are applied to the facility.
• It also involves planning and execution of documents such as,
protocols, records, or other.
• The standards will involve three elements:
• Regulatory and guidance documents
• National standards
• Company standards.
Methodology:

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• This section encompasses all aspects of the design, procurement,
installation, and commissioning process.
• The extent of qualification and re-qualification shall be decided
based on critical nature of equipment and system.
Qualification:

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• The very first part of the validation of any new equipment
Site, system or facilities could be the design qualification.
• It comprises the documented verification of equipment and
manufacturing facilities.
Design Qualification:

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• The objective of this qualification is to establish evidence
that all key factors of the process equipment.
• It should be coherent to the manufacturers approved specification
along with recommendation of supplier of the equipment.
Installation Qualification:

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• The objective of this qualification is to establish the evidence that
process control limits and action levels as per predetermined
requirements.
Operational Qualification:

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• The objective of this qualification is to establish evidence that the
process, under anticipated conditions, consistently meets the
specified requirements.
Performance Qualification:

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• The CFR 21 states that each person engaged in and
each person responsible for supervising the manufacturing,
processing and holding a drug product.
• All employees shall be trained on good manufacturing practices
(GMP).
• Training evaluation should be carried out with proper training
records as per standard operating procedures.
• The training includes validation activities and calibration as per
international regulations.
Personnel:

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• The work programme is essential and should be prepared at an early
stage.
• A good plan will contain all necessary features which are to be
considered during execution of a plan.
• It ensures that all the personnel involved in the VMP are not only
aware of engineering targets but also the validation targets.
Schedule:

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• This is the responsibility of site maintenance and operation
department.
• It embodies all maintenance and support activities necessary to
ensure the validated status of the systems.
• For standard procedure refer SOP for preventive maintenance of
equipments.
• Part of review process must conclude and examination of any change
recording.
Preventive maintenance:

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• 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:
 Detail of change requested
 Reason for proposed change
 Impact and risk assessment of change.
Change control:

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• Some of the major and minor changes are:
Major changes: For a substance of microbiological and chemical
quality evaluation.
• Addition or deletion of step in manufacturing process.
• Change in quality of raw materials used in formulation
manufacturing process.
• Change in input quantities of formulation manufacturing process.

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• Minor changes:
Change in references( name/company name/address)
of manufacturing site.
• Change or updating the method of analysis used to test the substance.
• Change in supplier of starting and packaging material.
• Change in batch size.

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• Each change control contains 7 digits.
CC-001/18
• First 2 digits represent change control code (CC).
• 3,4,5 digits represent sequential change control number (001).
• 6,7 digits represent the current year (18).

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• 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.
Documentation:

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• In case of any additional information added to the existing protocol
addendum or supplement should be prepared.
• Supplement or addendum shall be retained along with the existing
protocol.

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• U.S. Food and drug administration, 21CFR 601.12 (a), April 1, 2000.
• International pharmacopoeia.
• 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 edition, 2003 pg no. 144-155.
References

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