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Module 1, Part 3: Process validation Slide 1 of 22 WHO EDM
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Validation Part 3:
Process validation
Supplementary Training Modules onGood Manufacturing
Practices
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Module 1, Part 3: Process validation Slide 2 of 22 WHO EDM
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Validation
Objectives
To review:
q Validation, risk analysis, and critical steps of
processing
q Points to consider in process validation of:
solid dose mixing
tablet compression
sterilization
q Finalization of validation
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Module 1, Part 3: Process validation Slide 3 of 22 WHO EDM
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Introduction
Validation
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Module 1, Part 3: Process validation Slide 4 of 22 WHO EDM
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Validation
Reliable, repeatable, undercontrol
q At least first 3 consecutive batches -
repeatable
q Must investigate failures
q The rationale should be documented if
experimental method is changed
documentdeviations, decisions and reasoning
q Does not improve processes
q Should not validate bad processes
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Module 1, Part 3: Process validation Slide 5 of 22 WHO EDM
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ValidationValidation
Design user or process requirements
Install installation qualification
Operate operational qualification
Validate performance qualificationand process validation
Review periodically (+ change control)
DQ, IQ, OQ and PQ
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Module 1, Part 3: Process validation Slide 6 of 22 WHO EDM
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Validation
Critical factors or parameters
q Need to be determined
q Need to be monitored during validation
q May affect the quality of the product
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Module 1, Part 3: Process validation Slide 10 of 22 WHO EDM
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Solid dose mixing (1)
q Homogeneity in blending the key to quality!
q Sampling strategy
q Sample site, label, container
q Storage
q Transport
q
Sample thief
Validation
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Module 1, Part 3: Process validation Slide 12 of 22 WHO EDM
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Validation
Tablet compressionvariables
q Fill volume
q
Pre-compression force, compressionforce
q Turntable speed
q Dwell time
q Granule size and feedq Ejection force, lubrication
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Module 1, Part 3: Process validation Slide 13 of 22 WHO EDM
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Validation
Tablet compressionparameters
q Mass
q Hardnessq Moisture
q Friability
q Disintegrationq Dissolution
q Thickness
Tablet coatingvariables
q Spray rate
q Inlet and outlet air tempq Coating weight
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Module 1, Part 3: Process validation Slide 14 of 22 WHO EDM
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Validation
q Lethality of
cycleq D value
q Z value
q
F valueq Fovalue min 8
Thermal Death Curve
1
10
100
90 95 100 105 110 115 120 125
Temperature (oC)
Moist heatsterilization
Z
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Module 1, Part 3: Process validation Slide 15 of 22 WHO EDM
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Validation
Sterilization validation (1)
q Sterility test
q Physical measurementsq Chemical and biological indicators
q Loading patterns
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Module 1, Part 3: Process validation Slide 16 of 22 WHO EDM
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Validation
Sterilization validation (2)
q Cooling fluid or gas
q Automated process
q Leak tests
q Control instrumentation
q Steam quality
q Heat distribution
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Validation
Dry heat sterilization
q Parameters
q Air circulation, positive air pressure, HEPA
filterq Advantages
microorganisms destroyed
depyrogenation possible
q Disadvantages poor heat transfer
higher temperatures for long periods
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Module 1, Part 3: Process validation Slide 18 of 22 WHO EDM
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Validation
Process variation
Controllable causes of variation mayinclude:
q
Temperature, humidityq Variations in electrical supply
q Vibration
q Environmental contaminants
q Lightq Human factors
q Variability of materials
q Wear and tear of equipment
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Module 1, Part 3: Process validation Slide 19 of 22 WHO EDM
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Validation
Change control
q Must be a review procedure for
validated processes
q From time to time changes may be
necessary
q Documented change control procedure
needed
q Like for like" changes do not require
re-validation
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Module 1, Part 3: Process validation Slide 20 of 22 WHO EDM
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Mixing validation liquid and soliddose
change control and scale up
q Mixer type and size
q Batch size
q
Pilot study scale upq Limit on the proportion
of the scale up
Validation
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Module 1, Part 3: Process validation Slide 21 of 22 WHO EDM
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Validation
Finalization of validation process
q Final report required
q Summarize and reference protocols and
resultsq Conclusion required: Is the process valid
q Final report should be reviewed and
approved by
the validation team
authorized person
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Module 1, Part 3: Process validation Slide 22 of 22 WHO EDM
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Validation
Group Session
q You are given a tabletmanufacturing flow chart
to studyq List the critical steps that are
required to be validated
q List the critical equipment
required to be qualified
q Identify the variables and
construct a table as directed
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