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.
An ECP plan can be devel- oped in newly established com- panies prior to the transfer of the first product from development into production and Quality Con- trol (QC). The plan, in this case, will serve as a “roadmap” for the identification and creation of the procedures, training, records, and supporting activities required to establish the ECP.
For existing companies, an ECP plan can be developed as an evaluation tool. The plan, in this case, can serve as an assess- ment for the adequacy of the pro- cedures, training, and record- keeping to support a balanced ECP. A balanced program re- quires facility and utility design, raw material selection, cleaning procedures, personnel/material flows, preservative systems, and environmental monitoring proce- dures that result in a minimal risk to product and patient safety that is consistent with product and regulatory requirements.
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