T 30: Identifying TPPs and Establishing CQAs to Support Commercial Product Specifications
Carrie A. Shults
Development Group Leader, Research Scientist
Lyophilization Technology, Inc. United States
This presentation progresses through the steps in establishing finished product specifications based on desired Critical Quality Attributes from defined Target Product Profiles.
This study involves the assessment of current practice and FDA Guidance for the process of investigation and definition of a drug from drug discovery through commercial product specification.
Co-Author: Denise L. Miller
There are no qualitative studies involved. The poster discusses a process as defined by the FDA and applies this process to the evolution of a lyophilized dosage form.
Development of commercial product specifications need to start with identifying the TPP in initial development work, focusing on the CQAs as the product progresses through to commercial manufacturing.
Identifying TPPs and Establishing CQAs to Support Commercial Product Specifications
Authors: Carrie A. Shults, Denise L. Miller, Edward H. Trappler
A Target Product Profile (TPP) is a summary of the proposed finished drug product quality characteristics established during development. A TPP is a useful guide bringing focus to desired product quality, safety, and efficacy. The TPP is dynamic; to be further defined as new knowledge is gained over the product lifecycle. The TPPs result from enhanced product knowledge and as such, aid in discussions with drug discovery and product development teams, clinical groups, manufacturing organizations, as well as regulatory agencies. This allows for ease of risk-based decisions, and product and process improvements.
As a new drug progresses to clinical development, the focused studies yield further insight into TPPs and enhancement of potential Critical Quality Attributes (CQAs). “CQAs are physical, chemical, biological, and microbiological properties or characteristics that should be within a certain specified range to ensure finished product quality.” As an example, typical CQAs for lyophilized dosage forms are aspects affecting purity, strength, and stability. Once identified, CQAs can be prioritized as essential or desirable through risk based analysis to form a hierarchy of relative importance. Further development focuses on essential CQAs and manufacturability considerations, which are paramount when a product progresses through clinical manufacturing to commercial manufacturing.
This presentation progresses through the steps in establishing finished product specifications based on desired CQAs from defined TPPs.