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Regulatory requirement
Validation / qualification
Validation
The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes
Qualification
A process of assurance that the specific system, premises or equipment are able to achieve the predetermined acceptance criteria to confirm the attributes what it purports to do
Tend to think of qualifying equipment, systems etc. and validating processes and procedures
Validation / Qualification
predetermined specifications and quality attributes……
Validation / qualification
CAR
4 wheels……….
Family car……………
One to pull boys/girls with……......
Why validate?
To demonstrate a state of control over the processes, equipment, and facility systems
To reduce errors, and generation of inaccurate results
Ensure results are reproducible
Regulatory requirements
Validation activities should be:
• Planned
• Follow approved protocol with defined acceptance criteria set out in advance of validation
• Fully documented with any changes and deviations noted and investigated as appropriate
• Should consider ‘state’ of processes , equipment etc
• Performed by suitably trained personnel
Validation / qualification
QC controls
Analytical method
validation
Equipment used in analytical method
qualification
Ongoing verification
Stages… eg buying as new piece of equipment for the labUser Requirement SpecificationSet out what you want from the piece of equipment
Design QualificationIf bespoke piece of equipment
Installation QualificationTo ensure installed and working properly with all required services
Operational QualificationTo ensure the equipment operates to the standards you require and in compliance with URS
Performance QualificationThe equipment is challenged to demonstrate is can work reproducibly within the specified working range
Introduction of iPS
Train staff
Buy equipment against your requirements
Source reagents and determine supplier suitability
Write protocols
Perform work
Document results
Produce summary report
………………………………………..Aims, hypothesis, results and conclusion
Introduction of iPS
Validation protocols (VMP)
Equipment qualification
Flow cytometer
Illumina Reagent qualification
Light cyclerQualification of
ancillary material egheat block
Assay validation
Flow Cytometry Flurochrome selection & qualification
NGS
PCR
Introduction of iPS
Validation protocols (VMP)
Equipment qualified
Flow cytometer
Illumina Reagent qualification
Light cyclerQualification of
ancillary material egheat block
Assay validation
Flow Cytometry
NGS
PCR
Regulatory requirements – Assay validation
Specificity
Accuracy and precision
Linearity
Repeatability
Reproducibility
Limit of detection
Limit of quantification
Robustness
VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY ICHQ2(R1)
Introduction of iPS
Validation protocols (VMP)
Equipment qualified
Flow cytometer
Illumina Reagent qualification
Light cyclerQualification of
ancillary material egheat block
Assay validated
Staff trained
SOPs in place
Flow Cytometry
NGS
PCR
Process validation
Other considerations
Calibration
Maintenance
Moving labs
Tech transfer between labs
Scale out and scale up
Cell and Gene Therapy Catapult12th Floor Tower Wing Guy’s HospitalGreat Maze Pond London SE1 9RT
+44(0)20 3728 9500
Cell and Gene Therapy Catapult is a trading name of Cell Therapy Catapult Limited, registered in England and Wales under company number 07964711.
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