Containment
Article 15
1. Unless validated inactivation and cleaning procedures are established and maintained, dedicated production areas shall be used when materials of infectious nature or high pharmacological activity or toxicity are involved. 2. Appropriate measures shall be established and implemented to prevent cross- contamination from among others, personnel or materials moving from one area to another. 3. Production activities (including weighing, milling, or packaging) of highly toxic nonpharmaceutical materials such as biocides and plant protection products shall not take place in premises being used for the production of active substances. 4. Handling and storage of highly toxic nonpharmaceutical materials shall be separated from active substances. 5. A comprehensive and effective quality system incorporating adequate quality controls and quality risk management shall be used for determining the necessity for and the extent to which production areas may be used for the production of multiple active substances and to mitigate the risk of contamination.