IQ, OQ, PQ

By
Dr. V. P. Shedbalkar
Pharma Edge Centre (I) Pvt. Ltd.
Mumbai

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 Analytical Instrument Qualification

Analytical Instrument Qualification (AIQ) is documented

evidence that an instrument performs suitably for its
intended purpose and that it is properly maintained and
calibrated. Use of a qualified instrument in analyses
contributes to confidence in the veracity of generated
data.

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Components of data quality

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Analytical Instrument Qualification

• Qualification of instruments is not a single,

continuous process but instead results
from many discrete activities
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

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DQ

Timing and Prior to purchase of a new type

Applicability of instrument

Assurance of vendor’s DQ

Assurance of adequate support

availability from manufacturer
Activity

Instrument’s fitness for use in

laboratory

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IQ

Timing and At installation of each

Applicability instrument (new, old, or existing
unqualified)

System description
Instrument delivery
Utilities/facility/environment
Activity
Network and data storage
Assembly and installation
Installation verification
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OQ

Timing and Applicability After installation or major repair

of each instrument

Secure data storage, backup, and

archive

Activity
Instrument functions tests

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PQ

After installation and

Timing and Applicability
Activity
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periodically at specified
intervals for each
instrument
Preventive maintenance
and repairs
SOPs – operation,
calibration, and
maintenance
Prepare PQ Protocol
and acceptance criteria
Performance checks
Responsibility

1. Users:-
• Analysts
• Supervisors
• Managements
2. QA:-
• Understand Qualification process
• learn instrument application
• Review the process and documentation
• Whether it meets regulatory requirements

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Responsibility

Manufacture : DQ
• Use validation procedures to manufacture the
equipment
• Notify Hardware & Software defects discoverer
after a products release
• After users training
• Installation support
• Build preventive maintenance plan

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Software Validation

• Firmware
• Instrument Control, Data acquisition and
processing software
• Stand alone software

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Change Control

• Manufacturers add new features

• Correct known defects
• All changes may not always benefit user
• Adopt only the changes deemed useful
• Change control follows DQ/IQ/OQ/PQ

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Change Control…..

• DQ : Evaluate changed parameters

• IQ : Install the changes during IQ
– Determine which are the existing OQ and PQ
tests needed revision, deletion or addition as
result of this installed change
• OQ : Perform revised OQ testing
– Ensures instruments effective operation after
the change is installed
• PQ : Perform revised PQ testing

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Documentation

• 1. Static Documents
• Instrument catalogue
• Order copy
• Airway Bill
• Custom documents
• Packing list
• Any factory certificates
• Manufacturers manual
– Installation
– Operation
– Service, maintenance
• List of spares

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Documentation

2. Dynamic Documents
• Documents which are generated during OQ and
PQ
• Preventive maintenance
• Logbooks – Provides running records

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Thank You!

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