Trevor Deeks, Senior Director, Manufacturing Management Services from Emergent BioSolutions joined us at the World Vaccine Congress Washington to give us his take on regulatory expectations for a biological process:
What are the Regulatory Expectations for a Validated Process?
Â· A qualified facility that has been demonstrated to be capable of supporting the process
Â· An assessment of the critical process parameters and their Proven Acceptable Ranges (PAR) or establishment of the Design Space
Â· Qualification of the critical equipment and Regulatory Expectations & Definitions procedures that provide control of these parameters
Â· A quality system that ensures effective control of the process throughout the product lifecycle
Â· Process Qualification (A demonstration of consistency)
Â· Documented evidence
Â· Process Verification
So what criteria should be put into place to manage these regulatory expectations? Tell us your views below!
Why not download the full presentation and find out more about designing and validating a manufacturing process – the Quality by Design concept for validating a biological process:
Â· Overview of the current QbD concept
Â· Steps in validating a biological process with reference to the current FDA Guideline
Â· How to apply this in practice