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USP 1058 AIQ Risk Based Instrument Qualification Guidelines

This document discusses guidelines for risk-based analytical instrument qualification (AIQ) according to USP <1058>. It proposes categorizing instruments into groups A, B, and C based on their risk level. Group A instruments have no measurement capability and lowest risk, requiring only observation. Group B instruments require calibration. Group C instruments require full qualification due to their complex and highest risk nature. The document recommends developing a single, harmonized qualification protocol for each type of instrument, regardless of manufacturer, to simplify the qualification process. This approach can provide benefits such as faster, better, simpler and cheaper qualification.

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1K views1 page

USP 1058 AIQ Risk Based Instrument Qualification Guidelines

This document discusses guidelines for risk-based analytical instrument qualification (AIQ) according to USP <1058>. It proposes categorizing instruments into groups A, B, and C based on their risk level. Group A instruments have no measurement capability and lowest risk, requiring only observation. Group B instruments require calibration. Group C instruments require full qualification due to their complex and highest risk nature. The document recommends developing a single, harmonized qualification protocol for each type of instrument, regardless of manufacturer, to simplify the qualification process. This approach can provide benefits such as faster, better, simpler and cheaper qualification.

Uploaded by

luroguita
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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USP <1058> AIQ Risk-Based Instrument Qualification Guidelines

GxP Multivendor Lab Instrument Qualification Strategy

Objective: Understanding and Optimizing


Qualification Using Risk-Based Guidelines

Methodology: Components of Data Quality

Right Instrument
for The Work:
Suitable for use
Capable of work
Validated range of use

A harmonized protocol format simplifies the lab compliance managers tasks,


making it easier to understand, control, document and defend qualification data
as well as manage preventative maintenance (PM) and service.

Simplified 4Q Model

Is it designed to
your user
requirements?
Design
Qualification

Major Areas of
USP <1058> AIQ
Analytical Instrument
Qualification

Simplification of the Process:


Straightforward
Easy to understand
Harmonization

Flexibility in
determining what is
done in OQ and PQ

Risk Management:
Grouping Instruments into
A / B / C categories

Improving compliance and productivity within a laboratory


environment can be achieved by employing uniform protocols for
similar types of instruments from different manufacturers.

Group A: Includes standard equipment with no measurement capability

Example: A single qualification protocol can be devised for


qualification of standard HPLC systems from Agilent, Waters,
Shimadzu, PerkinElmer, and other vendors.

Simple / lowest risk

Employing a uniform protocol from instrument-to-instrument:

Standard equipment designed with no measurement capability or


requirement for calibration
Specification: As defined by manufacturer
Conformance with requirements verified and documented by observation
of operation
Examples: Magnetic Stirrers, Vortex Mixers, Sonic Baths, Shakers,
Class A Pipettes, Nitrogen Evaporators

2 Definition of
DQ / IQ / OQ / PQ

Roles & Responsibilities


Users
QA
Vendors

Group A: Observe

or requirement for
calibration. The manufacturers specification of basic functionality is accepted as the user
requirement.

Major Components of USP <1058> AIQ

1 Component of data quality:


USP <1058> AIQ is the
foundation of data integrity

One Straightforward Qualification Protocol

7
4

DQ

Before Purchase
What must it
do?
Specifications
Dynamic
This is the User
Requirements

Has it been
Installed
correctly?
Installation
Qualification

Does it
work as you
expected?
IQ

At Installation
Environment
Services
Review After
Installation
Performed by
Vendor or User

Operational
Qualification

Will it continue
to work
correctly?
OQ

Before Use
You Approve
You Review
When Done
Performed by
Vendor or User
SOP & Training

Performance PQ
Qualification
Ongoing
Does it
Continue to
work?
Event
Management
(PM)
Performed by
Vendor or User
Ongoing
compliance

Roles and Responsibilities

Users

Vendor / Supplier / Manufacturer

Ultimately responsible especially


definition of requirements
Attest to scientific validity of AIQ
Consultants, validation specialists, and
QA can assist
Must maintain the qualified state via PQ

Instrument design and manufacture


Quality manufacturing processes
Notification of all known users about
defects
Offer user training
Invite user audits as necessary

QA
Understand and review AIQ process

harmonized, uniform AIQ protocols

Examples: HPLC, GC, LCMS,


UV/Vis, Autoclave, Incubator, Ovens,
Freezers, Refrigerators, FTIR,
Dissolution

Right Method:
Parameters
Selectivity
Sensitivity
Suitability

One step in reducing the complexity of the qualification process is to harmonize


the process by developing one generic protocol - using USP <1058> AIQ
Analytical Instrument Qualification guidelines on risk-based compliance for all
instruments of the same type, regardless of manufacturer.

10

Gain the advantage of faster,


better, simple, cheaper
qualification by using uniform
and consistent protocols for
all similar instruments - no
matter the manufacturer.

Instrument Suitability:
Point of Use test
Resolution Etc.

Lab instruments are daunting to manage and qualify since they are generally
manufactured by different vendors, stretch across differing model years, and
may be combined in varied multivendor configurations, such as an LC/MS/MS
with an injector made by company X, an HPLC pump made by company Y, and
a triple quadrupole mass spectrometer from company Z.

Introduction to Groups A, B, and C

Quality Control:
QC Samples
Control Charts
Control results

Reducing the burden of compliance while also protecting regulatory status


is paramount in todays GxP environment. The key is devising a compliance
program that addresses instruments ranging from sophisticated LC/MS/MS to a
simple pH meter or hotplate while ensuring the process is cost effective and
efficient.

This presentation will review procedures and recommendations regarding the


level and degree of compliance required for various lab equipment based on
risked-based USP <1058> AIQ Categories A, B, and C and provide an overview
of harmonizing instrument qualification.

Results: Faster, better, simpler, cheaper qualification through

Group B: Calibrate

measured values as well as


equipment controlling physical parameters (such as temperature, pressure, or flow) that need
calibration. The user requirements are typically the same as the manufacturers specification of
functionality and operational limits.

Simplifies testing by creating standard tests and procedures


Consistent test procedures enable faster testing and quicker
turnaround
Uniform paperwork enables faster reviews and approvals as
well as audits

11

Conclusion

Group B: Includes standard equipment and instruments providing

Many of these instruments also have own USP general chapters, for example:
<21> Thermometers, <31> Volumetric apparatus, <41> Weights and
balances
Examples: Balances, pH Meters, Thermometers, Variable Pipettes, Flow
Meters, Pressure Meters, Water Baths, Timers, Centrifuges

Qualification is performed to document that


instruments are suitable for their intended use
and that they do what you expect them to do.

Qualification reduces risk Business and Compliance

Group C: Qualify

Group C: Includes instruments and computerized analytical systems where user requirements for
functionality, operational, and performance limits are specific for the analytical application.

Risks. Both can dramatically affect customers


businesses.

Business risk is the FAILURE of the instrument


to perform as intended.

Compliance risk concerns employing improper


Complex / highest risk
Full qualification process required for complex instruments and
computerized systems
Specific function and performance tests
Complicated undertaking and may require assistance of specialists
Examples:
Dissolution, HPLC, GC, LCMS, Spectrometers
Liquid Handling Systems, Robotics, Plate Readers
FTIR, Particle Size Analyzers, Sequencers

Lab Compliance Solutions, 2647 Gateway Road Suite 105 No. 460, Carlsbad CA 92009 www.LabComplianceSolutions.com

standards and procedures during instrument


qualification.

USP <1058> AIQ simplifies lab instrument


compliance by categorizing instruments
on a risk-based guideline, low risk to
high risk.

Reduce costs and improve efficiency by maximizing the use of vendor


documents and employing Protocol Harmonization.
Lab Relocation Poster, May 2011

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