Process Development and
Quality by Design (QbD)
This documentation provides the map to the production process used for manufacturing, and the justification for the technology. This includes laboratory studies to evaluate processing conditions, operational changes during the manufacture of clinical supplies, scale-up, relocation and technology transfer, and data trending.
The process must be characterized in terms of process-related impurities, process residuals and the final intermediates and product. An appropriate analytical testing and method qualification strategy should be developed to apply methods at non-routine test points in the process. The analytical characterization of the process provides the profile needed to understand the effectiveness of unit operations, and the levels of impurity and residual reduction.
In preparation for the validation stage, documentation directly related to the current manufacturing process must be updated to reflect the defined process technology. Critical documentation includes batch records, production support documents, and process-related SOPs. Routinely, a detailed process description is written to capture intellectual property and to serve as the basis of change control after the process has been validated. The detailed process description also identifies the parameters, controls and specifications of the process—which will be used as the foundation of the process validation exercise.
Examples of Our Process Development and Quality by Design (QbD) Services:
- Detailed Process Descriptions
- Process Understanding Studies
- Design of Experiments (DOE) Experiments
- Small Scale Model Equivalency Study
- Development Reports
- Support Validations (e.g. resin re-use and lifetime studies, membrane storage, sanitization and re-use studies, buffer and product hold time studies, filter validations, shipping validations, etc.)
- Technology Transfer
- Campaign Summary Reports
- Contract Site Management
- On-Site Manufacturing Support
- Development, Manufacturing, Regulatory and Commercial Release Schedules
- Regulatory Submissions
- Comparability Protocols