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.
The second guide in ISPE’s Advancing Pharmaceutical Quality (APQ) series provides a systematic and proactive approach to quantitatively assessing and advancing leadership systems by evaluating the management responsibilities highlighted in ICH Q10 as well as other key leadership components.