Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.
Environment FDA recommends that you consult published guidelines involving the housing and wellbeing of animal research models. The guidelines address recommendations for minimum housing, husbandry standards, social and environmental enrichment, and the development of standard operating procedures that address timely and adequate veterinary medical care. FDA believes that following these guidelines and allowing animals sufficient access to resources such as food and water receptacles, enrichment devices, clean and species-typical resting surfaces, provisions for postural adjustments, and adequate play and exercise are important. Comfort and familiarity with handlers can reduce background stress, thus potentially minimizing experimental confounding factors that could adversely affect the interpretation of your study results. In keeping with the standard of care, FDA recommends that the floors, walls, and ceilings of animal holding structures be non-porous in order to permit easy sanitization of surfaces. FDA recommends that there be adequate lighting and light controls to permit periods of normal daylight and opportunities for rest. FDA also recommends the utilization of facilities with appropriate environmental controls for temperature and humidity in order to prevent temperature stress and minimize respiratory infections.
Animal Groupings FDA regulation 21 CFR 58.43 requires testing facilities to have a sufficient number of animal rooms or areas, as needed, to assure proper separation of species or test systems. However, outside of the post-operative monitoring period, FDA recommends housing social animals in non specific groups. FDA cautions that the environmental conditions not interfere with the assessment of the study and that all animals have access to adequate resources such as food, water, and toys in order to prevent bullying and territorial stress.
Primary and Secondary Enclosures Because many Class III devices and implants associated with surgical procedures necessitate frequent observations during certain predicted sub-acute periods, FDA recommends that your facilities include access to small recovery rooms or enclosures that can provide intensive care treatments such as oxygen, swivel systems for intravenous medications, remote ECG monitoring, and temperature and/or humidity adjustment. FDA also recommends that you consider whether your protocol should include periods of animal holding in high-level experimental facilities, with subsequent transport to more agricultural facilities following post-procedural stabilization.
Transport Systems To minimize the stress animals can experience during transport, FDA recommends that you consider the use of transport cages with raised flooring, soft cushioning rest devices, carboys, hay nets, or other enrichment and food/water devices. Transport vehicles should afford animals environmentally-controlled heating and air conditioning in order to further minimize shipping stress. FDA notes that proper care in transport of animals is also addressed in other agency regulations.