As new, more sophisticated hardware and software systems are installed in automated manufacturing environments, companies must advance their validation processes. In an industry with limited room for error, flawless validation systems are vital to successful manufacturing.
According to industry experts, companies vary greatly in their awareness of the US Food and Drug Administration's current regulations on good manufacturing practices (CGMPs), and their ability to properly implement CGMPs into custom manufacturing systems. Thanks to additional resources such as the recently updated Good Automated Manufacturing Practice (GAMP) Guide published by the International Society for Pharmaceutical Engineering (ISPE, www.ispe.org), pharmaceutical companies are in a better position to ensure that production results are identical every time.
Throughout the organization, automated systems must be validated to demonstrate control over the production environment.
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