Transcript Validation and Qualification Overview 2007

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Validation and
Qualification Overview
Mike Garry
Software Product Manager
Spectroscopy Software Platform Team
Customer Regulatory Requirements
 Control in the generation and
archiving of analytical data
 Rigorous documentation
 Is the system “Fit for purpose”?
 Controlled by predicate regulations
that apply:
• cGMP, GLP for Pharma
• ISO 9000 for non-Pharma
 In the pharmaceutical industry this
requires complete system validation
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GLP vs. cGMP
GLP
cGMP
• Good Laboratory Practices
• 21 CFR Part 58
• Required for non-clinical
studies supporting NDA
submissions
• Often used as general
guidelines for laboratory
quality management
• current Good
Manufacturing Practices
• 21 CFR Part 210 & 211
• Required for all aspects of
manufacturing, processing,
and packaging of a drug
• Used for quality control in
drug manufacturing
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What is Validation, Anyway?
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Validation of a Spectrometer
 Process of ensuring that the
complete system (more than just
the spectrometer) is fit for a
specific process or application
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Instrument
Software
Method
SOPs
 cGMP and GLP requirement
 Typically performed by instrument owner, however;
• Thermo Fisher Scientific provides the customer with tools that are
needed to complete validation
• Thermo Fisher Scientific can also provide custom spectrometer
validation services to do complete end-to-end validation through
our Spectroscopy Validation Program
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The FDA’s View
Confirmation by examination and provision of objective
evidence that... specifications conform to user needs
and intended uses, and that the particular
requirements implemented… can be consistently
fulfilled.
- FDA Guidance Document (1999)
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The Big “V” View of Validation
User
Requirements
Specifications
User
Acceptance
Testing
Functional
Specifications
System
Testing
Design
Specifications
Integration
Testing
Build
System
This is the process we use to design and develop products.
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Qualification vs. Validation
 Qualification is a stage in the validation process
 Qualify individual areas of a process
• For example FT-IR instrument used for drug development
 The exact requirements for qualification and validation will
vary depending on the environment used
• R&D vs. clinical laboratory vs. production facility
 Four parts of qualification (The 4 Q’s)
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Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
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Instrument Life Cycle Management –
How Thermo Fisher Scientific Helps
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Qualification Steps - Example
Customer is ultimately responsible, they look to vendors to provide the tools!
DQ
IQ
OQ
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PQ
Design Qualification (DQ):
Customer’s Responsibility
 Done before system purchase
 User defines critical features and
specifications of the system
 They must ensure the instrument
specifications meet the analytical
method requirements
 Must compare environmental needs
of instrument to conditions of
proposed location
 They typically analyze the vendor’s
product development process
• Questionnaires
• Audits
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Design Qualification (DQ):
Vendor’s Responsibility
 Document hardware/software development process
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Product Development Process (PDP)
ISO 9001 certification
Quality system
Hardware and software validation
 Product design, manufacturing, testing, and support
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Traceability
Design process
Development process
Data and bug tracking
Change control notice
Problem escalation
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Installation Qualification (IQ)
 Verification and documentation that the instrument is:
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received as ordered and specified in DQ
defect and damage free
installed properly in the correct environment
meets manufacturer’s specifications
 Includes all aspects of the instrument set-up:
• hardware, software, documentation, log book present
• power up, software control, data output
 Performed by customer or vendor
• trained and certified service technician (proof required)
• ValPro Installation Certification services provide factory traceability
• may include checklists or testing scripts
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Operational Qualification (OQ)
 Verifies that the hardware & software operate according to
specifications
• system performance tests
• done as part of IQ
• tests that the • spectrometer runs as a spectrometer
• software runs as expected
• accessories operate properly
• operators trained in basic instrument use
 Thermo Fisher Scientific provides tools and services to
complete OQ of spectrometer (Installation Certification)
 Repeated after major service, moves or annually as
determined by the instrument owner
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Operational Qualification (OQ)
 Verifying that the software/hardware operates according to
specifications
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routine performance tests
frequency defined by system owner
generally includes a subset of the IQ test
tests that the spectrometer runs as a spectrometer
 Responsibility of customer
• define SOPs
• define tests to run and frequency
 Thermo Fisher Scientific provides tools and services to
complete OQ of spectrometer (Installation Certification)
 For software this is a detailed functionality test
• plan for verifying that the software operates according to
specifications
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Performance Qualification (PQ)
 Tests and documents system to be adequate for specific task as it relates
to the manufacturing process
• unique to every location and use
• includes spectroscopic method verification (system suitability)
• documents system is fit-for-purpose
• SOPs (Standard Operating Procedures) must established and followed
 Includes ongoing performance verification tests and re-qualification
• Intervals determined by the system owner
 Tailored to:
• user
• experiment
• SOP for instrument use
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Qualification & Validation Tools
 ValPro System Qualification for
laboratory FT-IR & Raman
 ValPro System Qualification for
Antaris FT-NIR and IGS
 Include:
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DQ documentation
IQ and OQ procedures
Qualification tests
Traceable standards
 Services available include:
• Installation certification
• System operation certification
• Provided by certified engineers
 Validation services available through
the Spectroscopy Validation Services
Group
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Software Qualification Products
 OMNIC DS Software OQ
• Detailed tests of 21 CFR Part 11 features of OMNIC and Thermo
Security Administration software.
• Comes in bound manual and PDF format
• Included with OMNIC DS package
 OMNIC Test Scripts for Software OQ
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Detailed tests for most common OMNIC commands and operations
Tests general OMNIC operation
Same test scripts that are performed when OMNIC is released
Document format for manual execution and signoff
Documents provided in PDF and DOC format
Additional charge for this package
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