QBD Analytical Method
ICH Q8 (R2) describes the nature of Quality by Design (QBD). QBD is a systematic approach to pharmaceutical manufacturing and development. Based on exact science with incontrovertible evidence, QBD aims at bringing about product and process understanding and process control. QBD seeks to bring all these about by beginning with predefined objectives.
The flow of processes in a QBD approach would typically be thus:
- selecting the product profile
- defining the critical quality attributes (CQA)
- performing risk assessment by linking raw material attributes and process parameters to CQAs
- cultivating a space for design
- arriving at a control strategy
- accomplishing product lifecycle by making continual development an integral part of it.
Analytical methods used in QBD
Both analytical and advanced analytical methods are used in QBD to achieve the end result of product and process development.
Analytical methods:In using analytical methods, QBD makes use of measurement of Critical Quality Attributes of everything relating to the product –the raw materials, intermediaries and the final product. Secondly, it supports risk assessment based on these qualities.
Advanced analytical methods: In order to achieve and enhance greater manufacturing control, a QBD uses analytical methods, which form the basis of Process Analytical Technology (PAT) and Real Time Release Testing (RTRT). This is done for process monitoring and for achieving continual improvement.
What purpose do these analytical methods achieve?
Precise analytical methods help achieve the following:
- they help aggregate the selected product profile
- they enable exact measurement of product CQAs and the intermediaries used in the process
- they help identify and fix measurements and controls used in the process
- they provide inputs with which to track and trend processes, leading to continual improvement in the process and the product.