iSpeak Blog

ISPE GAMP SIG MES Planning to Move the Industry Forward

Christian Wölbeling
Dirk Sweigart, BSME, BSCS, MBA
Mark J. Wager
ISPE GAMP SIG MES Planning to Move the Industry Forward

With a recent increase in interest and participation, the ISPE GAMP® Special Interest Group (SIG) focusing on Manufacturing Execution Systems (MES) has mapped out an ambitious number of subject areas to use as the basis for future publications, presentations, and best practice guidance documents. With the co-leadership of Christian Wöelbeling, Executive Industry Advisor at Körber Pharma Software GmbH and Mark Wager, Quality Consultant at Eli Lilly and with ISPE sponsorship from ISPE International Board of Directors Chair, Mike Rutherford, Executive Director, Computer Systems Quality & Data Integrity at Syneos Health and the team of over thirty industry professionals is sharpening their focus on the implementation and use of MES for the purposes of verification and validation of Master Batch Records, Audit Trails, Data Integrity, and integration with process control systems among others.

Of course, these are just “buzzwords” unless context and an understanding of the use cases is provided. That is where this SIG comes in. This team expects to provide further guidance on justification, implementation, operation, and integration of MES together with an understanding of Industry 4.0 to support the ISPE Pharma 4.0TM Operating Model. This guidance will include using risk-based approaches and the functional relationship between an MES and other systems (such as ERP, LIMS, process control, and other Level 2 systems, and the human operators) within the context of the ISPE Pharma 4.0 concept of an overall holistic control strategy.

Assessing and benchmarking readiness/maturity of current operations as well as understanding the role of MES in the Pharma 4.0 operated factory of the future will also be included in SIG efforts.

We’re excited to move forward as a GAMP SIG and share our knowledge with the ISPE community. Watch the ISPE iSpeak Blog page for future updates.

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