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



SBU Pharma Liquid Training

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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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Life Cycle Equipment

DQ IQ OQ PQ PV

Qual.

Report

Val.

Report

Training Training

GMPOperation

ChangeControl




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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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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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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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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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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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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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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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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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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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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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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

13 Validation Phases

Documents

Transcript of 13 Validation Phases