An environmental control program (ECP) must be supported with control systems, and carefully balanced with facility design, cleaning procedures, personnel, flow patterns, and environmental monitoring. The program must be developed based on product requirements, existing environmental constraints, and what can “practically” be performed, managed, and controlled on a routine basis. Use logic. Understand the underlying rationale behind the program, and the relative risks associated with each element that supports the program. Focus on the objectives of the program, and ensure adequate control is in place to meet those objectives. There is no substitute for a common-sense approach to the design and implementation of an ECP. The below checklist and SOP attempts to support this objective.