At the process validation stage, we perform formal process validations, continue to manage risks, and complete the integration of the supply chain.
High-level outputs
- Complete equipment installation qualifications (IQ)
- Prepare operational qualifications (OQ)
- Continue implementing training plan
- Conduct production readiness build
- Capture performance qualification (PQ)
- Conduct additional inspections per risk mitigation plan
- Finalize supply agreements
- Implement ramp up plan (with daily stand-up meetings)
- Implement performance metrics
Results
The process is validated via process validation protocols and reports that provide objective evidence that all acceptance criteria have been met. The Tech Transfer team reviews and approves the validation reports, as well as all documentation of other deliverables, before moving on to the next phase of production start-up.
Tools
We use a detailed process validation process—with checklists and forms, following established standard operating procedures and ISO requirements—to consider, plan for, and validate every requirement for manufacturing, packaging, and delivering your product. We work closely with you to find the best solutions for your goals, and discuss key production and process decisions and trade-offs.
