GE P&W Sievers Technology Transfer Protocols User Manual

GE Power & Water

Fact Sheet

Water & Process Technologies

Analytical Instruments

Sievers Technology Transfer Protocols

A QSO Product for Upgrading from Legacy Sievers TOC Analyzers
to the 900 and 500 RL Models

In the drug industry, implementing changes
or change management is often discussed
in terms of resources, documentation, and
time spent on the manufacturing process
or the nal product. However, changing
from legacy technology to new technology,
in addition to implementing a process for
new TOC analyzers, requires a structured
procedure and tools.

To help with this objective, GE Analytical
Instruments has released Technology Tran­sition Protocols that facilitate the change
from the Sievers 400 ES to the 500 RL, and
from the Sievers 800 to the 900 Series Labo­ratory TOC Analyzers. Since the transition to a new TOC
analyzer can take a signcant time commitment, GE’s
unique validation protocols (tools) can greatly accelerate
this conversion.

Aligning with the Current Best
Practices Process

By denition, the International Conference of
Harmonization (ICH) describes a form of technology
transfer in ICH Q10 as “activities or validation steps
associated with the transfer of process knowledge
or data between departments, manufacturing sites,
or related technologies/ equipment.” However,

this document states that “this
knowledge forms the basis for the
manufacturing process, control
strategy, process validation approach
and ongoing continual improvement.”
It is important to note, though, that
without a clear path in transitioning to
new TOC technologies, this can be a
multifaceted process.

In addition to ICH Q10, the United
States Pharmacopeia (USP) has come
forward in USP <1058> Analytical
Instrument Qualication to provide

additional guidance by highlighting
a transition to new technology associated with
analytical instruments. USP <1058> suggests that this
type of transition involves a form of “change control”
that should evaluate elements of design, as well as
operational and performance qualication. Figure 1
highlights GE Analytical Instruments’ rationale and
justication for developing these transition protocols.

Key Components of GE’s
Transition Protocols

TOC instruments have historically been employed to satisfy
compendial requirements involved in the measurement of
organic contamination in pharmaceutical waters. When

Figure 1. The Transition Process for New TOC Technologies

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 instrumenta­tion technology comparison

• Similarities in system suitability results to satisfy
compendial specications

• An equivalency study of accuracy and precision
verication to satisfy regulatory guidelines

Table 1 summarizes each element, scope, justication
and rationale for the transition process incorporated in
these specic 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, scientic approach designed to eciently
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 oor 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
oers a one-day on-site validation service and specic
reference standards to ensure an ecient transition
to new TOC technology. Furthermore, these transition
protocols can be fully integrated into GE Analytical
Instruments VSPs and on-site validation services oering.
To explore these and other GE Analytical Instrument
products, please visit www.geinstruments.com or contact
your local representative.

Table 1. GE Analytical Instruments’ Transition Protocols for the On-Line and Laboratory Analyzers

Elements Scope Justification & Rationale

Design Demonstration of ‘like-for-like’

technology comparison

Operation Comparison test of the operational

suitability of the two analytical
instruments

Performance Equivalency test of validation

characteristics for performance of
the two analytical instruments

Transfer Documentation to summarize both

methods are ‘like-for-like’ in design,
operation, and performance

The Americas

GE Analytical Instruments
6060 Spine Road
Boulder, CO 80301-3687 USA
T [phone]
T [phone]
F [phone]
[e-mail]

Europe/Middle East/Africa

GE Analytical Instruments
Unit 3, Mercury Way
Urmston, Manchester
UK M41 7LY
T [phone]
F [phone]
[e-mail]

www.geinstruments.com

© 2011. General Electric Company. All rights reserved.

Compare oxidation and detection techniques
based on the design of the TOC technology
and vendor specifications

Demonstrate that the transition to the new
instrumentation is suitable and operates
under actual conditions of use

Justify that the transition to the new
instrumentation provides comparable results
based on accuracy and precision with the
same check standards

The ‘like-for-like’ technology incorporated in
both instruments and results from the
comparison tests further facilitates the
transfer from one technology to another.

Asia Pacic

GE Analytical Instruments
7/F, Building 2, No. 5 Hua Tuo Rd.
ZhangJiang Hi-Tech Park, Pudong
Shanghai, China 201203
T +(8621) 38777735
F +(8621) 38777469
[e-mail]

300 00236 Rev A

MC11-188