Formulation design is crucial to ensure that our products meet quality expectations. By applying QbD principles, we can systematically understand the relationship between critical formulation factors and their impact on Critical Quality Attributes (CQAs). Key elements to consider: 1. Quality Target Product Profile (QTPP): Defines the desired quality characteristics of the final product. 2….
Critical Process Parameters (CPP), Critical Quality Attributes (CQA) & It’s Stages 1) Wet Granulation 2) Drying 3) Milling 4) Mixing 5) Compression 6) Coating Read also:
Process capability measures the inherent variability of a stable process that is in a state of statistical control in relation to the established acceptance criteria. Calculations based on the inherent variability due to common cause of a stable process (i.e., in a state of statistical control) result in process capability (Cp and Cpk) indices….
The knowledge gained through appropriately designed development studies culminates in the establishment of a control strategy. As shown in the picture, control strategy could include three levels of controls as follows: Level 1 utilizes automatic engineering control to monitor the CQAs of the output materials in real time. This level of control is the…
A pharmaceutical manufacturing process usually consists of a series of unit operations to produce the desired quality product. Unit operations may be executed in batch mode or in a continuous manufacturing process. A process is generally considered well-understood when: (1) all critical sources of variability are identified and explained (2) variability is managed…
Over the years, QbD’s focus has been on the process design, understanding, and control, as discussed in the ICHQ8 (R2) guidance. It should be emphasized that product design, understanding, and control are equally important. Product design determines whether the product is able to meet patients’ needs, which is confirmed with clinical studies. Product design…
QbD, or Quality by Design, is a systematic approach to pharmaceutical development and manufacturing that aims to ensure product quality by design, rather than by testing and inspection after production. But the principle of QbD can be applied to all stages of the product lifecycle, from research and development to commercial production. Key Components…
