Quality by Design for Drug Development

Publications Presentations

Patent Preparation Expert Witness

New Product Acquisition Drug Delivery Systems

Preformulation Formulation and Process Design Analytical Method Development and Validation Feasibility and Stability Quality By Design IND CMC Documentation Bioavailability Reverse Engineering of Pharmaceucial Formulation

Quality By Design Process Optimization Scale-Up and Clinical Manufacture Analytical Methods Regulatory Stability Process Validation Technical Transfer Bioequivalence Testing NDA CMC Documentation

Quality By Design for Excipients Excipient Safety Regulatory Alternate Sources Quality Management Systems

Excipients Drug Delivery Systems Clinical Trial Supplies Medicinal Products

'Quality by Design' (QbD) is one of a series of programs that the FDA includes in their 'Quality in the 21st Century' initiative. In summary, this program emphasizes the fact that quality cannot be tested into anything, it has to be built in. In this particular instance the built-in quality is the understanding of the formulation and process. The built-in limits assure that the finished medicinal product will consistently deliver the drug in the correct amount, at the correct rate, over the shelf-life of the product.

In practice, if one is able to establish the 'Design Space' for the product, there may be significant post approval regulatory savings in terms of supplemental filings. When executed properly, QbD is the foundation for robust medicinal products and Process Analytical Technologies (PAT).

Much of the work associated with QbD and determination of the design space will be carried out as part of the process optimization and scale-up. This will build on the studies already carried out as part of the formulation and process design phase. Some work will also necessarily be carried out at full commercial scale.

FinnBrit Consulting has the knowledge and experience to advise clients on how to implement an effective Quality by Design strategy.

All information published throughout www.finnbrit.com is intended for information only, and does not contain any warranties, implied or otherwise.

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