Cold
Rooms and Stability Rooms / Chambers
Introduction
Cold Rooms and Stability Rooms / Chambers provide temporary or
long term storage of pharmaceutical, biotechnological and biological
products / samples.
Approach
The simplicity of the equipment often allows combined IQ/OQ protocols
or IQ/OQ/PQ protocols to be generated and performed. This significantly
reduces the amount of documents for review and approval whilst
still ensuring compliance with GMP is demonstrated.
To confirm cGMP compliance full documentation
and construction checks will be carried out. Empty and loaded
chamber thermal mapping to confirm the correct storage conditions
are achieved. All
critical components will be recorded to ensure a validated state
can be maintained.
The ambient temperature is also monitored throughout to confirm
the units are suitably located, according to the manufacturer's
specification.
We are conversant with current industry standards
and guidelines, including ICH Harmonised Tripartite Guideline 'Stability
Testing of New Drug Substances and Products Q1A(R2) and ICH Harmonised
Tripartite Guideline 'Stability Testing of Biotechnological/Biological
Products Q5C
Detailed validation reports are compiled that
contain all of the real-time data generated as well as a concise
summary, with a clear conclusion and details of any recommendations,
as appropriate.
Either a calibrated humidity sensor is connected
to the Validator 2000® and calibration verification performed
on site using traceable salts, or alternatively a stand alone
calibrated humidity logger is used.
Experience
PEV have experience of validating Vindon, Binder, CRC and many
other manufacturers of Cold Rooms and Stability Rooms / Chambers.
We can provide operational resource and assistance with the generation
of User Requirement Specifications (URS), through Factory Acceptance
Testing (FAT) to Site Acceptance Tests (SAT) and Installation Qualification
(IQ), Operational Qualification (OQ) and Performance Qualification
(PQ) protocols |