Quality by design Flashcards
QBD As defined in ICH Q8 (Product Development):
A systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and QRM.
QBD Principles (Process Design):
Product designed to meet patient’s needs.
Process designed to consistently meet CQAs
Impact of starting materials & CPPs on product quality is understood
Critical sources of process variation identified & controlled
Process continually monitored and updated to allow for consistent quality over time
QBD Design space (optional):
Combination and interaction of input variables & process parameters that have been demonstrated to provide assurance of quality.
Design space is proposed and subject to regulatory assessment & approval.
Once approved, moving within the design space is NOT out of specification.
QBD Quality Target Product Profile (QTPP):
A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product
QBD Multi-variate approach using DoE
DoE to improve our understanding of:
- Characteristics of product
- Process parameters
- Material properties
Looking at multiple variables and understand how they influence the product, process & materials. Enhances understanding of factors that will influence the process
QBD An enhanced, QbD approach to product development:
- A systematic evaluation, understanding and refining of the formulation and manufacturing process, including;
Identifying, through, prior knowledge, experimentation, and risk assessment, the material attributes and process parameters that can have an effect on product CQAs;
Determining the functional relationships that link material attributes and process parameters to product CQAs; - Using the enhanced product and process understanding in combination with quality risk management to establish an appropriate control strategy.
