FDA Compliance of Automation & Monitoring of Influenza Virus Vaccine (IVV) Facility
| Project Duration: |
12 Months |
| Project Budget: |
3.5M |
| Delivered Cost: |
3.6M |
| Works Included: |
To support its export of products to the USA, CSL required the upgrade of the Influx Virus Vaccine (IVV) Facility to Comply with the US Food and Drug Administration (FDA). This spanned Environmental Monitoring System (EMS), Process and Water For Injection (PWFI) and Allantoic Fluid Filtration (AFF). |
Project Outline:
- FDA compliance across a wide range of existing control platforms
- FDA compliance for new systems
- GAP analysis on existing installed systems
- FDA compliant system to be used for future project
The solution included:
- Integrated multiple technology platforms including historian, archiving, data recovery, audit trails, user management
- On-going live validation package
- New and expanded automation and monitoring systems
The short time span and the wide scope of the project required Synertec’s project management, validation and automation skills to be utilised in full.
The final system was delivered on time and passed an FDA audit the first time.
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