Section Contents Menu Field Science and Laboratories Method Validation Guidelines Laboratory Information Bulletins Laboratory Manual- Volume I - 5.3 Accommodation and Envir onmental Conditions ORA Laboratory Policies Food and Drug Administration DOCUMENT NO.: ORA-LAB.QMVERSION NO.:1.9 ORA Laboratory Manual of Quality PoliciesEFFECTIVE DATE: 10-01-03 REVISED: 01-22-13 5.3.1 Facilities and Environmental ConditionsThe 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 a ware 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 tes t are documented with the data generated. 5.3.2 MonitoringEnvironmental 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 hoo ds, metal contamination on benches and hoods in laboratories performing metal analysis,
