Demonstrating that the Manufacturing Process yields the desired result.
Process Qualification, also referred to as Process Performance Qualification, combines all aspects of a manufacturing facility to confirm that the ‘manufacturing system’ can reliably produce acceptable commercial batches. Process Qualification evaluates the Quality Attributes (CQAs) of your process’s output. Within the life science industry common product Critical Quality Attributes are indications of strength, purity, and uniformity.
The key to any successful Process Qualification is understanding your product attributes and the means by which they can be controlled. Sequence’s perspective, combining the latest industry best practices, Quality and Compliance expertise, and a methodology for delivering successful process validation results efficiently, is what makes us unique.
- Project Management
- Quality controlling parameter determination (DOE, Multivariate analysis)
- Evaluations / Studies
- Process improvements (increased efficiency, productivity)
- Raw material qualification
- MBR Manual process development
- Automated process development
- Validation Plan development
- Efficient validation strategy determination (minimize release interruptions)
- Process Validation test execution
- Validation Summary development
- Release Report Development
- SOP Development
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