Development to Commercial scale
It is very important to ensure that the drug product retains the intended Critical Quality Attributes when transferred from the development lab to a commercial scale manufacturing. This is done by identification of the Critical Process Parameters and challenging them during the scale up and transfer of the technology from lab scale to commercial manufacturing within the scope of regulatory guide lines.
Involves critical steps like identification of the Critical Quality Attributes (CQA) of the product to be transferred, identification of the Critical Process Parameters (CPP), identification of the working principles of the equipment’s / machines involved in the manufacturing, comparing the working capacities and assessing the impact of the changes in any of the above aspects on the quality of the product.
In the current scenario, Pharmaceutical manufacturers conduct more technology transfers now than ever before, yet technology transfer remains far from a core competency in the industry.
Technology Transfer has evolved to align with concepts and terminology used in industry and regulatory developments including science and risk-based (“Quality by Design”) principles described in
- ICH Q8 Pharmaceutical Development
- ICH Q9 Quality Risk Management
- ICH Q10 Pharmaceutical Quality System