Quality control areas
Article 14
1. Quality control areas shall generally be separated from production areas. Laboratories for the control of biologicals, microbiologicals and radioisotopes shall also be separated from each other. However, in-process controls may be carried out within the production area provided that they do not carry any risk for the products. 2. Quality control areas shall be designed to suit the operations to be carried out in those areas. Sufficient space shall be given to avoid mix-ups and cross-contamination during testing. Adequate storage space for samples and records shall be available. Separate rooms may also be required to protect sensitive instruments from vibration, electrical interference, humidity, or any other condition that may have a negative impact on their performance. 3. Special precautions shall be taken in quality control areas handling hazardous substances, such as biological samples.