Quality by Design principlesPatient-centric manufacturing Process development is the exercise of creating new and improved manufacturing methods, optimizing them in terms of time and financial efficiency while maintaining regulatory compliance and product quality.
The challenge of scaling up Many common drug compounds are produced by now well-understood synthetic routes that are fairly easily scaled up by typical chemical engineering methods, i.e., larger batches or faster continuous production methods. As the production scale increases, complex facilities are increasingly required to accommodate the reaction.
Many other production methods suitable for small-scale production in the laboratory falter at large scale. For example, centrifugation is employed to separate biological products for many specific purposes, such as collecting cells and separating proteins, and can be performed in detail by a manual operator working with moderate quantities.
Quality must be built into the product and its manufacturing process in order to ensure a sterile and pharmaceutically effective product. QbD is therefore concerned with process development and manufacturing efficiency, particularly the elimination of defects via process understanding and control. Large pharmaceutical companies may employ in-house quality control services or alternatively may employ the services of contracting laboratories with enhanced GMP experience and certification.
Efficiency and cost-effectiveness Scaling up of production processes can improve efficiency, firstly regarding worker hours required to produce the final product, and secondly regarding materials cost and wastage. If the same synthetic steps are taken, a single batch should take the same amount of time to complete no matter the batch size, and can thus be monitored by the same number of employees.