ORA Laboratory Policies
Food and Drug Administration
5.3.1 Facilities and Environmental Conditions
The laboratory environmental conditions facilitate the correct performance of analytical testing. Test methods used by the laboratory include instructions addressing applicable environmental conditions. Examples of environmental influences are energy sources, lighting, biological sterility, dust, humidity, and temperature. The laboratory monitors critical environmental conditions to ensure that results and the quality of the measurement are not adversely affected or invalidated.
In the event mobile labs are deployed, the laboratory is aware of, and complies with, all the environmental requirements and laws for the location. The technical needs for accommodation and environmental conditions that can affect the results of test are documented with the data generated.
Environmental conditions requiring monitoring include, but are not limited to:
- room temperature and humidity,
- air flow rates for chemical fume hoods,
- biosafety hoods and laminar flow hoods,
- metal contamination on benches and hoods in laboratories performing metal analysis,
- microbiological contamination on bench surfaces and hoods in microbiology laboratories, and
- air sampling for microbiological contamination in microbiology areas.
Where environmental controls are needed, the environmental conditions are recorded.
Testing activities are stopped when the environmental conditions invalidate the test results or adversely affect quality control. Monitoring activities are conducted as part of the laboratory test or calibration methods.
Separate areas are maintained for incompatible activities. Measures taken to prevent cross-contamination include but are not limited to:
- chemistry laboratories are separated from microbiology laboratories,
- sample receiving and storage are conducted in designated areas,
- separate storage for standards and reference materials and cultures, and
- microbiology media preparation and sterilization are separated from work areas.
Laboratories are limited access areas. Access is controlled by but is not limited to:
- issuance of keycards for entrance,
- escorting visitors,
- issuance of identification badges, and
- the use of security guards.
Laboratory areas are maintained clean and orderly to prevent contamination of samples and to facilitate the efficiency of laboratory operations.Volume II, Section 2, ORA-LAB.5.3 Facilities and Environmental Conditionsspecifies minimum housekeeping measures. The laboratory’s Chemical Hygiene Plan and Hazardous Waste Management Plan include measures taken to ensure good housekeeping in the laboratory.
- Volume II, Section 2, ORA.LAB.5.3, Facilities and Environmental Conditions
- Laboratory Chemical Hygiene Plan
- Laboratory Waste Management Plan