TRAINEE - World Health Organization

86
TRAINEES Chapter 4 • GLP Training Manual
Awareness of such “circumstances” depends largely on knowledge of the animals’
physiological and behavioural needs, the programme defined in SOPs and, of course,
the training of technical, quality assurance and scientific staff. The diversity of factors
that may interfere with a study is such that only major variables can be covered here.
There is, however, substantial and helpful literature on this subject.
Once SOPs are defined and approved for each situation (length and type of study,
species), data are collected and evaluated regularly by the professional staff. Variations
to the defined norm or alarming and unforeseen circumstances are documented and
evaluated for corrective action and for any possible effect on the study and consequent
consideration in the final report.
In general, each variable is evaluated regarding:
– Source
Examples: Temperature/humidity is often related to the HVAC system and the
presence and efficiency of a back-up generator. Bedding contaminants are usually
related to the manufacturer’s source of raw material. Soap or detergent residue
contamination depends on the rinsing efficacy of the cage washer. Air quality may
depend on the proximity of intakes to laboratory hood exhausts.
– Risk
Example: Barrier procedures against incoming microbiological contamination are
more important for lifetime studies than for acute studies. Bedding/litter characteristics
and noise can be critical for teratology or blood pressure studies – less so
for other types. Light timer failure can be more critical for albino strains than for
others. Water quality concerns can be much greater with automatic watering systems
than with bottles.
We can see that much of our risk evaluation is study, species or project specific
for example, feed characteristics (particle size) can affect diet-admix quality. Basal
dietary vitamin A level may be critical in retinoid testing but not for other families
of test molecules. Likewise, bedding characteristics can affect studies in many
different ways because of the physical and chemical characteristics.
– Monitoring
Example: Cage rinse analyses, certificates of analysis for feed, water and bedding,
environmental chart recorders, manometers, air turnover measurement, insect
pheromone traps, etc.