Process validation is a critical part in the manufacture and commercial distribution of medical devices or biopharmaceutics. Lack of adequate validation of the process by which a device is manufactured is a major cause of product recall and product liability. Just as important is the decision logic verification.
DBT’s approach to the validation process is inclusive of:
- Regulatory expectations consistent with GHTF Group 3 Process Validation guidance and FDA Process Validation Guidance.
- Guidance-specific validations for IVD, molecular diagnostic products and other biologics
- Integration of risk assessment into the validation or verification strategy
- The use of scientific or engineering principles specific to the process
- Definition of anticipated performance requirements based upon characterization and designs of experiments.
DBT can help your organization clearly focus on the essential elements of process validation or verification including essential equipment validation such as the following examples:
- In Vitro and bio-molecular diagnostics process and test method validation
- Analytical Laboratory Methods (Test Method Validation)
Electronic Assembly (PCB and component assembly) - Software used in manufacture
- Test and release of component mold and assembly validation
- Environmental
- Filling and Lyophilization
- Purified Water
DBT can assist your organization in the planning, project management, execution and audit of installation.