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Qualification Vs Validation
Qualification Vs Validation
Pharmaceutical Manufacturing
OBJECTIVES
• Discuss the requirements for Qualification
and Validation in Pharmaceutical
Manufacturing
• Appreciate the need for Validation
OUTLINE
• Definitions
• Validation documentation
• Qualification
• Types of validation
• Approaches
• Life cycle concept of validation
• Conclusion
INTRODUCTION
• Safety, quality and efficacy are built
into the product – cannot be
"inspected or tested into a product"
• Need for confidence that the product will
consistently meet predetermined
specifications and attributes
WHAT IS VALIDATION?
• “Validation is defined as the collection &
evaluation of data, from the process
design stage through commercial
production, which establishes scientific
evidence that a process is capable of
consistently delivering quality product.”
• Documenting that a process or system
meets its pre-determined specifications
and quality attributes
WHAT IS VALIDATION?
• EU GMP - it is “Action of proving, in accordance
with the principles of Good Manufacturing
Practice (GMP), that any procedure, process,
equipment, material, activity or system actually
leads to expected results.”
• The US FDA defines “Validation as establishing
documented evidence which provides high
degree of assurance that a specific process will
constantly produce a product meeting its pre-
determined specification and quality attributes.”
WHAT IS QUALIFICATION
• Performed to establish confidence that process
equipment and ancillary systems are capable of
consistently operating within established limits
and tolerances.
• Provides documented evidence that the subject
equipment has been installed as per
specification (manufacturer’s recommendation)
and will attain and maintain critical process
parameters repeatedly and reliably.
• A subset of validation, typically done as part of a
larger validation effort.
Comparison between Qualification and
Validation
• Validation and Qualification are essentially
components of the same concept.
• Qualification is normally used for equipment,
utilities and systems
• Validation is normally used for processes and
methods
• In this sense, qualification is often a part (the initial
stage) of validation but the individual qualification
steps alone do not constitute process validation.
• Process validation cannot take place without first
carrying out qualification
WHY VALIDATION?
• Assures Quality
• Regulatory Requirement
• Reduces Cost
Financial losses
Systems
equipment
• What to
Qualify/Validate
Responsibility
✓ Responsibility for
qualification and
validation is a multi-
disciplinary one which
includes:
✓ Heads of
Production and QC
✓Heads of
Engineering and
Contractors/suppliers
✓Respective
responsibilities
clearly defined in the
VMP.
Training
Calibration Certification
Change
control GMP Process
under control
Review
periodically
Pharm.(Mrs) Edosa Ogbeide 22
Commissioning
• Include equipment start- • Supplements validity and
up, adjustments, fine- regulatory compliance
tuning, cycle • checks to verify the
development, testing system or equipment is
and documentation built to design
flexibility. specifications
• Leaves the equipment in • No safety issues
a “State of Control”, • Takes place at the
which ensures the manufacturer’s premise
equipment is ready for (FAT) or User/Client’s
formal qualification, Premise (SAT)
testing, and approval.
Design qualification (DQ)
• Process of completing and documenting
design reviews to illustrate that all quality
aspects have been fully considered at the
design stage.
• To ensure that all the requirements for the
final systems have been clearly defined at the
start.
• In other words, has it been designed and
selected correctly?
Design qualification (DQ)
Before purchasing, a manufacturing
equipment
• Collection of data about similar equipment
available in the market
• Assessing your needs
• Resources to buy, operate, space and
maintenance they would need, etc.
• Making the decision
Installation Qualification (IQ)
• 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.
• To ensure that all aspects (static attributes)
of the facility or equipment are installed
correctly and comply with the original
design.
Installation Qualification (IQ)
Considerations include:
• Equipment design features (i.e. materials of
construction cleanability, etc.)
• Installation conditions (functionality, utilities, wiring,
etc.)
• Calibration, preventative maintenance, cleaning
schedules; safety features
• Supplier documentation, prints, drawings and
manuals, software documentation
• Environmental conditions (such as clean room
requirements, temperature, humidity)
• Spare parts list
Installation Qualification (IQ)
E.g., a manufacturing equipment
48
Pharm.(Mrs) Edosa Ogbeide
The Lifecycle concept of Process
Validation
• The Lifecycle concept links product and
process design, qualification of the
commercial manufacturing process and
maintenance of the process in a state of
control during routine production
• A science- and risk-based approach to verify
and demonstrate that a process operating
within predefined specified parameters
consistently produces material that meets all
its critical quality attributes.
Validation Maintenance
V M
A 1
A
I Change
2 Management Program
L
I N
D T
3 re-qualification
Periodic
A E
T N
I A
Periodic Validation Review
O N
N C
E
Eqmt
Facilities ****Note: Eqmt= equipment
Utilities
Processes
VALIDATION