Hi Pat,
It is not explicit in any stability guidance. This is more of a GMP
requirements to validate all instrument, equipment used. Please see the
following:
Clause 3.19 of the PIC/S GMP guide states:
"Storage areas should be designed or adapted to ensure good storage
conditions. In particular, they should be clean and dry and maintained
within acceptable temperature limits. Where special storage conditions
are required (e.g. temperature, humidity) these should be provided,
checked and monitored."
PIC/S doesn't offer much advice on what this means in practice. Luckily,
there are industry guidance documents which provide more information.
The most useful is the UK Guidance on Wholesale Distribution Practice,
which states:
"Large commercial refrigerators and walk-in cold rooms should be
monitored with an electronic temperature-recording device that measures
load temperature in one or more locations, depending on the size of the
unit. Portable data-loggers that can be downloaded onto a computer may
be used instead of a fixed device. Records should be checked daily.
Internal air temperature distribution should be mapped on installation
in the empty and full state and annually thereafter under conditions of
normal use. Products should not be stored in areas shown by temperature
mapping to present a risk (e.g. in the airflow from the refrigeration
unit). Condensate from chillers should not be collected inside the unit.
All warehouses should be temperature mapped to determine the temperature
distribution under extremes of external temperature. Mapping should be
repeated every two to three years and after any significant modification
to the premises, stock layout, or heating system.
While this guidance is not strictly enforceable in many parts of the
world, including Australia, it contains useful information about what
regulators might expect when inspecting temperature controlled storage
areas
Hope this helps.
Wilhelm
______________________________
Wilhelm Leung M.Sc., C.Chem., Eurchem
Executive Director, Analytical Development & Quality Control
QLT Inc.
t 604.707.7643
f 604.707.7807
www.qltinc.com
-----Original Message-----
From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Forenzo, Patrick
Sent: Wednesday, September 26, 2012 7:20 AM
To: [log in to unmask]
Subject: Re: [PSDGLIST] PSDGLIST] Can anyone point to a specific Health
Authority Guidance which mandates a remapping of stability chambers as
part of a periodic re-qualification
Can anyone point to a specific Health Authority Guidance/ ICH
requirement which mandates a remapping of stability chambers as part of
a re-qualification or is it more of an unwritten expectation ?
Patrick Forenzo
Senior Fellow / Stability Expert
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
USA
Phone +1 862 7786690
Fax +1 973 7812019
[log in to unmask]
www.novartis.com
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High quality controlled environmental walk-in rooms and reach-in
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Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
High quality controlled environmental walk-in rooms and reach-in chambers
Full installation, validation and spare parts also available
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
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