ISPE guide tackles automated manufacturing

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

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