QbD (Quality by Design) is a concept that has revolutionized the pharmaceutical manufacturing process. It is an approach which considers all aspects of drug development and manufacturing in order to design a process that consistently produces safe and effective products.
Through QbD, manufacturers are able to develop a robust process control strategy, create detailed quality practices, evaluate risk factors and make improvements that ensure product safety and efficacy.
QbD also enables manufacturers to not only reduce development cycle times but also minimize the need for costly post-approval changes, thus reducing costs throughout the entire lifecycle of their products. Furthermore, QbD allows pharma manufacturers to adapt their processes as needed in order to meet changing customer needs efficiently and cost-effectively.
Overall QbD provides an invaluable tool for pharma manufacturers who are looking to gain an edge within the industry through reduced production times and implementation of better control strategies that result in improved safety and effectiveness at every stage of their products’ life cycles.
QbD Process
Quality by Design (QbD) is a systematic and risk-based approach to pharmaceutical development, which integrates scientific understanding of the link between product quality parameters and process controls into the drug manufacturing process. This methodology is based on the concept that product quality should be designed into the final formulation and manufacturing process through continual improvement.
QbD seeks to use knowledge from pre-defined objectives, such as efficacy, safety, purity, or potency, to decide upon design strategies for both technical and regulatory acceptability of treatment options prior to beginning manufacture. The approach also encourages robustness in the selection of ingredients and processes used to ensure consistency in production as well as potential for scalability when needed for marketing. Ultimately, QbD seeks to provide greater assurance of quality by ensuring better control over key operational parameters affecting a drug’s performance throughout its full lifecycle.
- Step 1 Define Quality Target Product Profile (QTTP)
- Step 2 Identification of Critical quality attributes (CQAs)
- Step 3 Quality risk management (QRM)
- Step 4 Determination of Critical Process Parameters & CQA
- Step 5 Determine Design space
- Step 6 Control Strategy
Benefits of QbD
- Elimination of batch failures & defects
- Avoid problems & regulatory compliance
- Minimization of deviations
- Speed up of Manufacturing process
- Increase manufacturing efficiency & Cost reduction
- Reduce Project rejection rate
- Build scientific knowledge base for all products
- Better interact with industry on science issues
- Ensure consistent information
- Incorporate risk management in the Process
- Speed-up release decision