For aseptic manufacture of pharmaceutical products there has been a shift, primarily due to legislative regulations.1 Traditionally, monitoring has involved the classic portable monitoring of a cleanroom. New regulations have led to a requirement for an automated, remote monitoring solution. Various steps must be undertaken to implement an automated monitoring solution for a non-viable particle counting system. The steps also apply if you later enhance the non-viable system to include a viable monitoring or other environmental parameter component. There are several steps to be followed for the implementation of a system and the Good Automated Manufacturing Practices (GAMP2) guidance for the validation of these systems certainly forms the core of the requirements. A typical project follows the format design, build, install, test, and validate. Each of these has its own timeline.
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