The document discusses analytical instrument qualification, including the revision of USP chapter 1058. It describes the qualification process which involves design qualification, installation qualification, operational qualification, and performance qualification. It also covers roles and responsibilities, software validation, and change control, which are important aspects of ensuring analytical instruments are qualified and performing as intended.

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Analytical Instrument Qualification
USP chapter 1058 revision

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Analytical Instrument Qualification is the collection of documented evidence that an instrument
performs suitably for its intended purpose. Data Integrity and Data Security are both crucial
aspects of Analytical Instrument Qualification.
Multiple ways to demonstrate that an instrument is qualified and under control:
• Qualification
• Calibration
• Validation
• Maintenance
USP 1058 is a general guidance describing a scientific, risk-based approach to Analytical
Instrument Qualification. ‘Instrument’ refers to any apparatus, equipment, instrument or
instrument system used in pharmacopeia analysis.
Context

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2017 revision includes:
• Focus on an integrated risk-based approach
• Further clarification of certain elements
• Aligning the chapter with USP’s today usual phrasing
The classification in three groups A, B and C depending on the complexity of the instruments has
proven to be sound and will be retained.
Timeline
Publication is planned for December 2017
Context

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AIQ forms the base for generating quality data,
with each layer adding to the overall quality
Components of Data Quality
Quality
control
check
samples
System suitability
tests
Analytical method validation
Analytical Instrument Qualification

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• Analytical Instrument Qualification Process
• Roles and Responsibilities
• Software Validation
• Change Control
Index

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Analytical Instrument Qualification Process

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Not a single, continuous process but a series of interconnected activities over the lifetime of the
instrument:
• Generating the User Requirement Specification (URS)
• Qualification activities to establish fitness for purpose:
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Framework may be extended for complex systems to include(*):
• Functional Specifications (FS)
• Factory Acceptance Testing (FAT)
• Site Acceptance Testing (SAT)
Analytical Instrument Qualification
Process
(*) Not discussed any further in this presentation

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• Documented evidence to define the functional and operational specifications and intended
purpose of the instrument
• Performed by instrument manufacturer or user
• Minimal for commercial off-the-shelf instruments
Design Qualification (DQ)

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• Documented evidence to establish that an instrument is delivered as designed and specified,
properly installed in the selected environment and that the selected environment is suitable for
the instrument
• For any instrument that exists on site but has not been previously qualified, or not qualified to
current industry standards, existing documents should be collated and a risk assessment should
be undertaken to determine the best approach
• Typical activities in IQ:
• Instrument delivery
• Description
• Assembly and installation
• Software installation, network and storage
• Installation verification - testing
Installation Qualification (IQ)

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• Documented evidence to demonstrate that an instrument will function according to its
operational specification testing in the selected environment
• OQ demonstrates fitness for the selected use and should reflect URS
• Testing activities may consist of the following test parameters:
• Fixed parameters
à Fixed parameters such as length, height, weight or pressure. Such fixed parameters which cannot
change over the lifecycle of an instrument do not need to be retested later
• Software functions
• Secure data storage, back up and archiving
• Instrument function tests
• Software configuration
Operational Qualification (OQ)

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• Documented collection to demonstrate that an instrument consistently performs according to
the specifications defined by the user, and is appropriate for the intended use
• PQ verifies the fitness for purpose of the instrument under actual conditions of use
• Testing activities may consist of the following parameters:
• Performance checks
• Preventive maintenance and repairs (including calibration)
• Practices for PQ, change control, and periodic review
Performance Qualification (PQ)

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Roles and Responsibilities

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• Final responsibility for:
• Specifying their needs and ensuring that a selected instrument meets these needs
• Maintaining data quality and integrity
• The qualification of instruments and validation of systems
• The maintenance of the instrument in a qualified state through routine performance of PQ
• Users can be advised by:
• Instrument manufacturers or suppliers
• Validation specialists
• Quality Assurance personnel
• Consultants
• Users should be adequately trained in the instrument's use, and their training records should be
maintained as required by the regulations
Users

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• Role remains the same as for any other regulated activity
• Quality personnel have to assure that:
• The AIQ process meets all compliance requirements
• All processes are being followed
• Intended use of the equipment is supported by complete, valid and documented data
Quality Unit

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Quality or Technical Agreement required between user organisation and manufacturer, supplier,
service agents or consultant who supplies the calibration, maintenance, qualification or validation
services.
This agreement has to define the scope of work and the two parties’ responsibilities.
Manufacturers, Suppliers, Service Agents
and Consultants

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Software Validation

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It’s becoming increasingly difficult to separate hardware and software parts of modern analytical
instruments. To avoid overlapping and potential duplication, software validation and instrument
qualification can be integrated into a single activity.
Classification:
• Firmware
• Instrument Control, Data Acquisition and Processing Software
Software validation

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Firmware is considered a component of the instrument itself.
In some cases, firmware can be capable of fixed calculations on the acquired data. These
calculations must be verified by the user.
In some cases, firmware can allow user-defined programs for the instrument’s operations. These
need to be defined and verified for the intended purpose by the user. Any user designed programs
should be placed under change control and if possible restricted to authorised personnel.
Firmware

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Three types:
• Non-configurable software
• Configurable software including tools from supplier(s) to modify the business process
• Configurable software with custom additions
Supplier should develop and test the software according to a defined life cycle and provide users
with a summary of the carried-out tests. Ideally, the software development is carried out under a
quality management system.
Instrument Control, Data Acquisition and
Processing Software

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Change Control

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A change control process has to be put in place to guide the assessment, execution and
documentation of any changes to the instrumentation (including repair, maintenance and
relocation).
Change control applies to all qualification activities and it can follow the general qualification
process.
Change control

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General Chapter <1058> “Analytical Instrument Qualification” draft – USP Pharmacopeial Forum
Sources

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