CLEANROOM ENVIRONMENTAL MONITORING SYSTEMS, REGULATORY COMPLIANCE AND RISK MITIGATION

With the ever changing GMP and regulatory compliance requirements, the standards in place and the fact that a cleanroom continuous environment monitoring system is a fundamental process tool to monitor the manufacturing environment, it is critical that the planning, design, procurement, implementation, validation, performance and ongoing maintenance are meticulously organized. This article is designed to help and assist those of you who are in a position of quality, technical and production management in a life-science manufacturing environment. The information here comes from many years of hands-on experience in this Industry. The importance of incorporating such a strategy as outlined above will save issues that may arise further down the track of such a project. A risk assessment designed URS is a major contribution to a successful monitoring system and a well-developed testing and validation process is crucial. Selecting the right vendor with the ability to offer this type of experience is critical to the success of a project and a vendor audit is a positive move at the start of the process to ensure you are working with the right supplier.