The principles of quality risk management [ICH Q9, Annex II.4] should be applied to the design of buildings, facilities and controls for the purpose of containment, taking into consideration the pharmacological /toxicological /chemical /biological properties of the raw material, intermediate and /or API to be handled or manufactured. Appropriate containment measures and controls [ICH Q7, Section 4.42] include but are not limited to the following:
- Technical controls (e.g., dedicated production areas, closed/dedicated Heating Ventilation and Air
Conditioning (HVAC) system, closed manufacturing systems, use of disposable technologies,
design of facility and equipment for containment and ease of cleaning); and - Procedural (organisational) controls (e.g., cleaning, personnel flow, environmental monitoring and
training). - Monitoring systems are important to check the effectiveness of the containment controls.