TRAINING ON QUALIFICATION &

VALIDATION
SUNTARA COSMETICS PVT. LTD.
PREPARED BY:
PRATHAM CONSULTANTS

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• Introduction
• Qualification & Validation
• Validation: Approaches to Validation
• Scope of Validation
• Qualification
• Documentation
• Validation Master Plan
• Qualification and Validation protocols
• Qualification and Validation reports
• Qualification Stages

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• Design Qualification
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Requalification
• Revalidation
• Periodic Revalidation
• Revalidation after change
• Change Control
• Personnel

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• Validation is and essential part of GMP, and an element of QA.
• Basic Principles include:
– Safety, Quality and efficacy of products
– Built into the product – as it cannot be “inspected or tested into a product”
– Critical steps in the process need to be validated.
• Need for confidence that the product will consistently meet
predetermined specifications and attributes.
• Documentation associated with Validation
– SOP’s
– Specifications
– Validation Master Plan (VMP)
– Qualification protocols and reports
– Validation protocols and reports

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Validation work requires considerable resources such as:
• Time
– Work is subject to rigorous schedules
• Money
– May need specialized personnel and expensive technology.
• People
– Collaboration of experts from various disciplines.
– A multidisciplinary team, comprising of Quality Assurance, Engineering,
Production, Quality Control (other disciplines, depending on the product and
process to be validated)

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• Qualification and validation are essentially components of
the same concept
• The term “Qualification” is normally used for equipment,
utilities and systems
• The term “Validation” is normally used for processes.
• In this sense, “Qualification” is part of “Validation”

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• Two basic approaches:
– Evidence obtained through testing (prospective and concurrent
validation)
– Analysis of accumulated (historical) data (retrospective
validation)
• Whenever possible, prospective validation is preferred.
• Retrospective validation is no longer encouraged
• Retrospective validation is not applicable to sterile
products

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• Validation requires an appropriate and sufficient
infrastructure including:
– organization, documentation, personnel and finances.
• Involvement of management and quality assurance
personnel
• Personnel with appropriate qualifications and experience
• Extensive preparation and planning before validation is
performed
• A specific programme for validation activities in place
• Validation done in a structured way according to
documentation including procedures and protocols.
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• Validation should be performed:
– For new premises, equipment, utilities and systems, and
processes and procedures;
– At periodic intervals; and
– When major changes have been made.
• Validation in accordance with written protocols.
• A written report on the outcome to be produced.
• Validation over a period of time, e.g.
– At least three consecutive batches (full production scale) to
demonstrate consistency. (Worst case situations should be
considered.)

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• Demonstrate suitability for new manufacturing formula
• Process, materials and equipment to prove consistent
yield of a product of the required quality
• Significant changes (facilities, equipment, processes) -
should be validated
• Risk assessment approach used to determine the scope
and extent of validation needed

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• Qualification should be completed before process validation is
performed
• A logical, systematic process followed
• Start from the design phase of the premises, equipment, utilities
and equipment
• Major equipment and critical utilities and systems normally require
IQ, OQ and PQ.
• Some equipment, utilities and systems require only IQ and OQ as
the correct operation could be considered to be a sufficient
indicator of its performance.
• The equipment, utility and system should then be maintained,
monitored and calibrated according to a regular schedule.

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• Contains key elements of the validation programme.
• Consider, clear and contain at least:
– A validation policy
– Organizational structure of validation activities.
– Summary of facilities, systems, equipment and processes
validated (and to be validated)
– Documentation format (e.g. protocol and report)
– Planning and scheduling
– Change control and references to existing documents

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• Describe the study to be performed:
– The objectives of the study
– The site of the study
– The responsible personnel
– Description of SOPs to be followed
– Equipment to be used
– Standards and criteria for the products and processes
– The type of validation

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• Protocol contents:
– The processes and/or parameters
– Sampling, testing and monitoring requirements
– Predetermined acceptance criteria for drawing conclusions
• Description (how results will be analyzed)
• Protocol approved prior to use - changes approved
prior to implementation of the change

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• Written reports on the qualification and validation
performed
• Reflect protocols followed and include at least:
– Title and objective of the study; reference to the protocol;
details of material
– Equipment, programmes and cycles used; procedures and test
methods
• Results evaluated, analyzed and compared against the
pre-determined acceptance criteria.
• The results should meet the acceptance criteria.
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• Deviations and out-of-limit results should be
investigated. If these are accepted, this should be
justified. Where necessary further studies should be
performed.
• Responsible departments and QA to approve
completed report, including the conclusion

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• There are four stages of qualification:
– Design qualification (DQ);
– Installation qualification (IQ);
– Operational qualification (OQ); and
– Performance qualification (PQ).
• All SOPs for operation, maintenance and calibration
should be prepared during qualification.
• Training provided and records maintained.

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• Design qualification:
– Provides documented evidence that the design specifications were met.
• Design qualification (DQ) is the process of completing and
documenting design reviews to illustrate that all quality aspects
have been fully considered at the design stage.
• The purpose is to ensure that all the requirements for the final
systems have been clearly defined at the start.
• Design Qualification (DQ) defines the functional and operational
specifications of the instrument and details the conscious
decisions made in the selection of the supplier.
• DQ should ensure that instruments have all the necessary
functions and performance criteria that will enable them to be
successfully implemented for the intended application and to
meet user requirements.
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• Installation qualification:
– Provides documented evidence that the installation was complete
and satisfactory.
• Installation qualification (IQ) is the process of checking the
installation, to ensure that the components meet the
approved specification and are installed correctly, and to
see how that information is recorded.
• The purpose is to ensure that
– All aspects (static attributes) of the facility or equipment are
installed correctly and comply with the original design.
– All of the instrumentation components are identified and checked
against the manufacturer’s component listing.
– Control and measuring devices are calibrated

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• Operational qualification:
– Provides documented evidence that utilities, systems or equipment and all
its components operate in accordance with operational requirements.
• Operational qualification (OQ) is the process of testing to ensure
that the individual and combined systems function to meet
agreed performance criteria and to check how the result of
testing is recorded.
• The purpose is to ensure that all the dynamic attributes comply
with the original design.
• Each of the instrument’s function are checked to ensure that
they conform to the manufacturer’s specifications.
• This includes the use of certified, traceable electrical simulators
and standards to verify that the equipment is processing input
signals correctly.

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• Performance qualification:
– Provides documented evidence that utilities, systems or equipment
and all its components can consistently perform in accordance with
the specifications under routine use.
• Performance qualification (PQ), also called process qualification, is the
process of testing to ensure that the individual and combined systems
function to meet agreed performance criteria on a consistent basis and
to check how the result of testing is recorded.
• The purpose is to ensure that the criteria specified can be achieved on
a reliable basis over a period of time.
• The performance of the equipment for its routine analytical use is
checked to ensure that this complies with its specification.
• The temperature sensor readings are compared with a certified
reference thermometer. After calibration, the conductivity sensor
readings are compared using certified, traceable control standards.

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• In accordance with a defined schedule.
• Frequency to be determined (e.g. on the basis of
factors such as the analysis of results relating to
calibration, verification and maintenance)
• Periodic and after changes
– E.g. changes to utilities, systems, equipment; maintenance
work; and movement.
• Part of change control procedure

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• Processes and procedures - to ensure that they remain
capable of achieving the intended results
• Periodic revalidation, as well as revalidation after
changes
• In accordance with a defined schedule
• Frequency and extent determined using a risk-based
approach together with a review of historical data

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• To assess process changes that may occur gradually
over a period of time, or because of wear of equipment
• Consideration given to
– Master formulae and specifications.
– SOP’s
– Records (e.g. of calibration, maintenance and cleaning)
– Analytical methods

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• After change that could have an effect on the process,
procedure, quality of the product and/or the product
characteristics. (Considered as part of the change
control procedure)
• Extent depends on the nature and significance of the
change(s)
• Changes should not adversely affect product quality or
process characteristics

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• Changes of equipment which involve the replacement
of equipment on a “like-for-like” basis would not
normally require a validation.
• For example, installation of a new centrifugal pump to
replace an older model would not necessarily require
revalidation.

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• SOP followed – as changes may have an impact on a
qualified utility, system or piece of equipment, and a
validated process and/or procedure.
• Describe the actions to be taken, including the need for
and extent of qualification or validation.
• Changes should be formally requested, documented
and approved before implementation.
• Records should be maintained.

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• Demonstrate that personnel are appropriately
qualified, where relevant.
• These include, for example:
– Laboratory Analysts,
– Personnel following critical procedures,
– Personnel doing data entry in computerized systems,
– Risk Assessors.

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