Tech Transfer and Process Performance Qualification (PPQ: Ensuring Quality, Robustness and Consistency in Pharmaceutical Manufacturing)
Information
The successful execution of technical transfer and PPQ at CDMOs is fundamental to ensuring the quality, robustness, and consistency of pharmaceutical products. By adhering to rigorous protocols, CDMOs can effectively transfer manufacturing processes and establish reliable, robust processes, ultimately contributing to the success of drug development and patient safety. In this presentation the methods involved in the technical transfer process for intermediates and APIs from the parent company to the CDMO are discussed.
This includes comprehensive information on the manufacturing process, equipment, analytical methods, and quality control procedures. Effective technical transfer ensures a smooth transition and minimizes any potential risks or deviations during the manufacturing process. Process characterization studies that are employed to evaluate process performance and capability are also discussed. It encompasses the identification, verification, and validation of critical process parameters and establishes their acceptable ranges to ensure consistent product quality.
It is essential to meticulously evaluate and optimize these parameters to establish reliable manufacturing processes. Finally, the presentation includes case studies to illustrate these strategies and the successful execution of PPQ batches at the CDMOs, highlighting real-world examples of the benefits derived from effective technical transfer and PPQ processes. Through efficient knowledge transfer, meticulous parameter qualification, and rigorous batch analysis, CDMOs can establish reliable manufacturing processes that ensure the quality, robustness, and consistency of intermediates and APIs.
