Pharmaceutical Production Facilities – Automation Control System Qualification
Published May 23, 2024
Clients
- JAG Process Solutions
- CSL
Location
- Melbourne, Australia
Core Capabilities
- Project management
- Stakeholder engagement and management
- Factory acceptance testing
- Validation services
- Compliance services
- Good Manufacturing Practice (GMP) compliance
Get in touch today to see how Synertec could help you with your next project.
Project Summary
Synertec have been engaged both by CSL directly and by their system integrator JAG Process Solutions to deliver validation and qualification of automation control systems and MES for all major pharmaceutical production facilities at CSL’s Broadmeadows site. The systems have included the JAG process control and MES suite, and Werum PAS-X MES.
The Challenge
CSL and JAG required an experienced partner with a deep understanding of automation control systems, MES and the complex processes of a pharmaceutical facility, and extensive experience in Good Manufacturing Practice (GMP) validation services.
Synertec's Solution
Synertec worked with both JAG and CSL to develop and execute testing strategies on qualification and production sites. GMP procedures were followed as per CSL’s requirements to validate the computer systems.
Testing developed, executed or reviewed by Synertec covered the following methodologies:
- Normal operation
- Negative testing
- Infrastructure
- Peripheral devices and remote terminals
- Electronic batch records
