Achieving automated control and compliance of drug manufacturing, at both the project and operations phases, is among the topics covered in the newly released GAMP Good Practice Guide: Manufacturing Execution Systems. MES, according to the document, can aid in automating and coordinating compliance, project, and operations activities.
The 144-page ISPE guide describes MES for regulated industries as a collection of manufacturing-related functions that integrate business and process controls, information flow, and human interaction. The intent of the guide ($380; $145 for members) is to help users narrow their interpretation of regulatory standards for improved compliance.
Manufacturers generally see a return on their MES investments in one to three years, says Christian Woelbeling, senior director at MES maker Werum, speaking recently at a user forum in Japan. The right-first-time approach benefits manual manufacturing processes in particular, he says. And the review-by-exception approach can "dramatically reduce" batch release approval times.
- here's the Guide announcement
- see the Werum forum summary