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Dear Reader,
Welcome to the first v:kit
newsletter of 2007. In this publication we aim to keep users and
distributors updated on the latest developments in the equipment
qualification arena.
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Presentation
on equipment qualification using v:kit
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At the
IVT conference on Equipment Qualification & System Validation in
Laboratory and Manufacturing Environments held in Amsterdam, The
Netherlands on December 5-7, 2006 Steve Luke from NLG and Karl Fitt,
Analytical Manager, Chemical and Pharmaceutical Development, Evotec (UK)
Ltd presented the following session:
INTERACTIVE
SESSION 11 Wednesday, December 6, 2006 3:30 PM - 5:00 PM HPLC
Qualification Case Study: An Example From the Real World
For
those not able to attend this conference you can now view the
presentation by clicking here.
If you
are interested in a v:kit presentation on equipment qualification for
your company or customers, then use the link below.
I am interested
in an NLG presentation on equipment qualification
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Have
your say on new v:kit features
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v:kit is a continually evolving product and as part of this
process we would like to give you the opportunity to contribute your
opinions
Please
give each of the features below a score out of 5, where
1 = Not a useful product feature
and
5 = A very desirable product feature
- Data disc CD-ROM
replaced with USB key
- A common user interface
for HPLC and GC v:kit
- Test procedures
integrated into the software
- A comments field
available for each test
- The option to have your
own company logo appear in the software
- An inlet pressure
accuracy and tightness test for GC v:kit
- A quicker to deliver UV
linearity test for HPLC v:kit
- A quicker to deliver
detector linearity test for GC v:kit
Please also let us know about any
features not listed above that you would like to see in v:kit.
You can copy and paste the features
above into an e-mail and send them with your scores via the e-mail link
below.
Take advantage of this
opportunity to influence the future of v:kit!
Send your
scores
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Compliance Watch
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Here are two recent examples of FDA warning letters.
One cites non-conformance with cGMP the other with GLP. Both are related
to the calibration/qualification of equipment.
6.
INCELL failed to adequately maintain and calibrate equipment used to
generate, measure, or assess data in nonclinical laboratory studies. [21
CFR § 58.63 (a)].
The [redacted] reader used to generate stability data requires periodic
quality control tests of linearity and precision. These tests have not
been performed and an appropriate interval for the performance of these
tests has not been established to assure acceptable performance of the
[redacted] reader.
1.
Failure to routinely calibrate, inspect, or check automatic, mechanical,
or electronic equipment according to a written program designed to assure
proper performance [21 CFR 211.68(a)]. Specifically, your [redacted]
lacks qualification according to a written plan to assure all parts of
the system, including the pump, power supply, electric components, vacuum
hold and cryogenic jacket, will operate properly for their intended use
every time [see Form 483 (483) Observation 1].
Read
the full warning letters at:
http://www.fda.gov/foi/warning_letters/g6187d
.htm
http://www.fda.gov/foi/warning_letters/g6172d
.htm
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See v:kit at Pittcon 2007
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NLG
Analytical will once again be exhibiting v:kit, our unique product for
the qualification of analytical instruments, at Pittcon 2007.
The
Pittcon exhibition will be held this year in Chicago, IL from Monday,
February 26 to Thursday, March 1.
Our
booth number this year is 1984.
Click
here to view the floor plan.
We will
be exhibiting the full range of established and new v:kit products,
including:
- HPLC v:kit
- HPLC v:kit for PQ
- HPLC v:kit flow meters
- HPLC v:kit auto_flow
- GC v:kit
- GC v:kit for headspace
- GC and HPLC instrument
parts
See our program entry - here.
If you are visiting Pittcon this year we
would be pleased to see you at our booth. Or if you prefer you can make
an appointment for a meeting off the booth.
Click here to make
an appointment
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