Test Method Validation
Problem
An IVD manufacturer required that certain processes used to manufacture its products be validated per FDA requirements. The issues for the process validation were basically that validated processes were not in use by the manufacturer for a number of products and Warning Letters had already been received from the Agency requiring that validation be completed. Management had a strict timeline for the completion of this effort with a goal for obtaining a Letter of Substantial Compliance from the Agency.
Consultant Method
This process validation project was reviewed for scope and range of activities necessary for successful completion such as the number of products included, their process ranges and other associated validation requirements. Some staff training was necessary to introduce fundamental background topics such as validation vs. verification concepts per the Agency’s definitions. These included expectations of the FDA such as found in Guidance for Industry documentation, this consultant’s past experiences and expertise and Quality publications.
The project was organized into major areas for the necessary work including :
- Test Method Validation
- Process Characterization
- Statistical Methods
- Process Validation
For each item the appropriate documentation and control was established. Required Critical Quality Attributes, Critical Process Control steps and other performance criteria were established and agreed upon by the team and Management. Protocols were developed for each of the work areas and executed by the technical team.
In this project the consultant’s background in applied statistical methods allowed for efficient statistical design and data analysis. This included appropriate DOE designs, multiple linear regression analyses and specification tolerance development for test methods and a concise description of the Process Capability for the validation.
Consultant Results
Validation activities were completed with a clear description of the ranges within which the Process was robust and valid and included all affected products. The compiled results were reviewed with Agency representatives and the specific statistical analyses and data were determined to be appropriately supportive of the results and the Process Limits that had been established. This Company was successful in addressing the Agency’s concerns through this set of Validation activities and received a Letter of Substantial Compliance based on the project’s submitted information.
To see the resume of the expert associated with this case study, see the link below.
