ISPE and the Open-SCS Working Group of the OPC Foundation signed a memorandum of understanding at the 2017 Europe Annual Conference in Barcelona.
The OPC Foundation is a global not-for-profit organization that pursues interoperability in automation by creating and maintaining open specifications to standardize the communication of acquired process data, alarm and event records, historical data, and batch data to multivendor enterprise systems and between production devices.
The agreement formalizes a collaborative relationship to promote a technical standard for system integration for health care packaging, serialization regulation compliance reporting, and mass tracking of serialization numbers.
This GAMP®-based implementation will define:
The open packaging serialization global name space
The packaging serialization user requirement specification for business and operations processes
The packaging serialization system integration functional requirement specification (EPCIS framework), which will become a GS1 EPCIS standard application
The packaging serialization OPC-UA companion specification with OPCF compliance certification
Secondary goals include promotion of the Open-SCS serialization work by ISPE and promotion of the GAMP-based development and implementation by the foundation’s Open-SCS Working Group.
Before traveling to the 2019 ISPE Annual Meeting & Expo in Las Vegas, the ISPE Japan Affiliate held its annual phar-maceutical plant tour over five days (21–25 October), visiting two plants in Los Angeles, one in Boston, and one in In-dianapolis.
The 2019 ISPE Max Seales Yonker Member of the Year Award was presented to Charlie Wakeham, a data integrity and compliance specialist based in Sydney, Australia, who has played an instrumental role in the development of GAMP®.