Quality by Design (QbD)
The FDA strongly encourages the use of a Quality by Design approach and now looks for QbD components in the submissions that they receive. This systematic approach ensures a higher quality final product by bringing in an understanding of the manufacturing instrumentation and production processes that will be utilized to develop the final product into the analytical research and development process.
Rather than relying on finished product testing alone, QbD requires identification of all critical formulation attributes and process parameters as well as determination of the extent to which any variation can impact the quality of the finished product. This ensures that insights flow upstream throughout the entire development process. Therefore, a quality issue can be analyzed efficiently and its root cause quickly identified.
QbD formalizes product design, automates testing, and streamlines troubleshooting. Its components include:
- A quality target product profile
- Critical quality attributes
- Critical process parameters (CPPs)
- Critical material attributes of drug and excipients
- A control strategy
Utilizing a Quality by Design Approach:
- Supports regulatory encouragement
- Saves manufactures time and money
- Ensures patients that they are receiving a more consistent and higher quality drug product that meets safety and efficacy requirements
Avomeen is an experienced and knowledgeable drug development partner. Our dedicated pharmaceutical development teams brings together multiple sources of information, extensive industry experience, and provides practical insights into issues with your product. Our methods not only help clients understand and implement QbD, but also accelerate your products momentum helping your company to launch a valuable drug product in the most robust, reliable, and cost-efficient manner.