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Transcript of 13 Validation Phases
8/6/2019 13 Validation Phases
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SBU Pharma Liquid Training 2002
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Validation Phases
Validation Phases
By Alain Kupferman
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Validation Phases
Qualification / Validation Activities Design Qualification
Installation Qualification
Operation Qualification
Performance Qualification
Product Validation / Process Validation
There are no FDA approved machines
FDA does not approve or prohibit specific equipment and materials
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Validation Phases
Life Cycle Equipment
DQ IQ OQ PQ PV
Qual.
Report
Val.
Report
Training Training
GMPOperation
ChangeControl
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Validation Phases
Design Qualification Definition of critical pharmaceutical parameters
necessary for a good, reproducible function of the equipment
adapted to the needs of the product to be manufactured
in line with current regulations
Description
Role in process
Materials
Output / Range / Sizes
Controls (I,C,R,A)*
*(Indicate, Control, Record, Alarm)
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Validation Phases
Installation Qualification
I.Q. is a stage in the process validation exercise normally executed by the
engineering group.
The installation of equipment, piping, services and instrumentation is undertaken and
checked to engineering drawings (Piping & Instrument Drawings, P.&I.D.) and plant
functional specifications developed during the project planning stage.
I.Q. will involve the identification of all system elements, service conduits and gaugesand a documented record that all installed equipment satisfies the planned
requirements.
Identification and documenting of maintenance requirements for each installed item
and the collection and collation of supplier operating and working instructions,
maintenance and cleaning requirements should form the minimum documentationand records for a satisfactory Installation Qualification.
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Validation Phases
Performance of formal IQ IQ requires a formal and systematic check of the installed equipment
against equipment supplier's specifications.
As-built check
Check against PID
All equipment should be identified with serial number, label, tag. Formal check using IQ test document
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Validation Phases
Installation Qualification IQ Issue overall IQ plan
Identify key documents and specifications
Develop IQ protocols
Use change control
Identify calibration requirements
Consider pre-delivery check (FAT)
Perform formal IQ
Detail preventative maintenance
Issue IQ report
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Validation Phases
Development of IQ, OQ, PQ, ... protocols formal document
specifies tests and testing activities
Use change control
Company system
Control updates to specifications
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Validation Phases
Identify key documents and specifications P & I Ds
Engineering Drawings
Layout Drawings
Equipment Data Sheets and Specifications
Valves
Indicators
Pumps
Filters
Equipment Certificates
Equipment Labels
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Validation Phases
Identify calibration requirements Confirm calibration of calibrating equipment with reference to
national standard
Calibrate measuring devices used in OQ where no confirmation of
calibration exists
Calibrate measuring devices related to installed equipment
Identify calibration requirements for measuring devices for future
use of equipment
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Validation Phases
Operation Qualification
O.Q. is an exercise oriented to the engineering function, generally referred
to as commissioning.
Critical variable (parameter) studies of the operation of the equipment and
systems will define the critical characteristics for operation of the system or
sub-system.All testing equipment should be identified and calibrated before use.
Test methods should be authorised. implemented and resulting data
collected and evaluated.
An effective change control procedure should be operational and encompass
the whole project from the pre-planning stage through to the final acceptance
of the process validation exercise
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Validation Phases
Operation Qualification OQ
issue OQ plan
identify critical features, limits, modes
design the OQ tests and issue OQ protocols
check installation, calibration and commissioning are complete
perform OQ tests, possibly in simulation mode
issue OQ report
release the equipment for use
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Validation Phases
Consider pre-delivery check
For large or complicated pieces of equipment a manufacturer may
elect to carry out a pre-delivery check at the supplier's assembly
plant. (FAT)
The pre-delivery check is not a substitute for IQ
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Validation Phases
Which points are critical to the Auditor ?
Design Process
Qualification / Computer Validation
Maintenance Planning and Implementation
Calibration
Change Control Deviation Control
Requalification
Operation of equipment
Data Integrity
Training programs