3.3.1 Fit-for-purpose working environment

​​​A. Background & Definitions

The working environment must be appropriate to ensure adequate and safe working practices and to minimize disturbance that would interfere with the validity of the study.

B. Guidance & Expectations

• Experimental rooms must be suitable to meet the requirements of the study.
• Storage rooms for samples, reagents, supplies and equipment should provide adequate protection against deterioration or contamination. Safe storage for hazardous substances should be ensured.
• Animal housing should be performed under controlled conditions (see 3.4.1.4 Animal environmental conditions).
• Handling and disposal of wastes should be carried out in such a way as not to jeopardize the integrity of studies (collection, storage, decontamination, transportation).
• Archiving conditions should protect contents from untimely deterioration.

Extra care has to be taken:

• Where important, environmental parameters such as temperature and humidity should be monitored and acceptance ranges should be defined.
• Where appropriate, there should be contingency plans in case of power failure or other disruption.
• Where special facilities are used they must be regularly checked and maintained (e.g. fume cupboards, heating, ventilation and air conditioning (HVAC), cold rooms).

​PLEASE DO NOT FORGET​

• Keep maintenance records of special facilities (e.g. fume cupboards, heating, ventilation and air conditioning (HVAC)​, cold rooms).
• In case of suboptimal working/storage environment conditions (e.g. acceptance ranges for temperature or humidity are exceeded) this should be documented in the study along with impact assessment.
• Any regulations that define additional standards associated with specific laboratory hazards (e.g. ionizing radiation, controlled substances, biohazard, animal allergens) must be adhered to.

C. Resources

tba

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Next item: 3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use​