Service
Process performance qualification and media fill
We plan, execute and report process performance qualification and media fill campaigns for submission to regulators.
Process performance qualification is the final validation stage before commercial manufacturing. We provide strategy, protocol development, execution support and regulatory submission preparation for the Therapeutic Goods Administration, the US FDA, the European Medicines Agency and ANVISA.
For aseptic operations we plan and support media fill campaigns in line with EU GMP Annex 1, including intervention design and environmental monitoring review.
What we deliver
- Process performance qualification strategy and planning
- Protocol development and review
- Media fill programme design and execution
- Execution support and oversight
- Statistical analysis and reporting
- Annual product quality review integration
- Regulatory submission support
- Recovery of failed campaigns
At handover
What you receive
- Process performance qualification strategy and protocols
- Media fill programme with intervention design
- Statistical analysis of campaign results
- Final reports prepared for regulatory submission
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View serviceDiscuss your project with an engineer
Tell us the scope, the site and the timing. A director will reply within one business day.