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1 The quality control laboratory should be separated from the production area. Where biological, microbiological or radioisotope test methods are applied they should be separated from each other.
2 Quality control laboratories should be designed to suit the operations carried out in them Sufficient space should be provided to avoid mixing and cross contamination. Sufficient suitable storage space should be available for samples, reference standards (with cooling, if necessary), solvents, reagents and records.
3 Design of laboratories should take into account suitability of construction materials, smoke resistance and ventilation. Separate ventilation should be provided in laboratory and production areas. Biological, microbiological and radioisotope laboratories require separate air-handling units and other provisions.
4 A separate room may be required to protect the devices against electrical interference, vibration, contact with excessive moisture and other external factors or where isolation is required.
