Validation services and additional products, Elements scope justification & rationale – GE P&W Ultrapure and Drinking Water TOC Analyzers - Sievers Technology Transfer Protocols User Manual
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transitioning to “newer or updated versions” of these
analyzers, regulatory bodies have suggested that a series
of protocols be conducted when transferring to the new
instruments, technologies, or methods in order to ensure
that the new approach is suitable for the intended use per
current Good Manufacturing Practices (cGMPs).
The overall intent of GE Analytical Instruments’ Technology
Transfer Protocols is to align with ICH best practices that
the “new method, instrument, or equipment needs to
demonstrate that it performs equivalently to, or better
than, the previous validated method, instrument, or
equipment.” To achieve this goal, the protocols have been
designed emphasizing:
• “Like-for-like” methods through an instrumenta-
tion technology comparison
• Similarities in system suitability results to satisfy
compendial specifications
• An equivalency study of accuracy and precision
verification to satisfy regulatory guidelines
Table 1 summarizes each element, scope, justification
and rationale for the transition process incorporated in
these specific protocols.
Quality System Optimization (QSO)™ —
Accelerating the “Change” Process
The new transition protocols are part of GE Analytical
Instruments’ Quality System Optimization (QSO)
program. In 2010, QSO was introduced to the
pharmaceutical and biopharmaceutical industries as
a risk-based, scientific approach designed to efficiently
implement TOC analyzers for real-time release (RTR)
testing of pharmaceutical water. QSO provides the
framework for transitioning TOC testing from the
laboratory to the production floor within an integrated
compliance foundation. This type of “platform” was
used to design these transition protocols to accelerate
the process of changing from legacy technology to a
new technology.
Validation Services and Additional Products
In addition to these documents, GE Analytical Instruments
offers a one-day on-site validation service and specific
reference standards to ensure an efficient transition
to new TOC technology. Furthermore, these transition
protocols can be fully integrated into GE Analytical
Instruments VSPs and on-site validation services offering.
To explore these and other GE Analytical Instrument
products, please visit www.geinstruments.com or contact
your local representative.
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Elements
Scope
Justification & Rationale
Design
Demonstration of ‘like-for-like’
technology comparison
Compare oxidation and detection techniques
based on the design of the TOC technology
and vendor specifications
Operation
Comparison test of the operational
suitability of the two analytical
instruments
Demonstrate that the transition to the new
instrumentation is suitable and operates
under actual conditions of use
Performance Equivalency test of validation
characteristics for performance of
the two analytical instruments
Justify that the transition to the new
instrumentation provides comparable results
based on accuracy and precision with the
same check standards
Transfer
Documentation to summarize both
methods are ‘like-for-like’ in design,
operation, and performance
The ‘like-for-like’ technology incorporated in
both instruments and results from the
comparison tests further facilitates the
transfer from one technology to another.
Table 1. GE Analytical Instruments’ Transition Protocols for the On-Line and Laboratory Analyzers