Single-Use systems, enabling faster more cost effective bio-pharma manufacturing, must also meet high quality parameters and standards while conducting component qualification, manufacturing operations, inprocess testing, and final product release.
For single use systems, quality control during the manufacturing process is critical. In a traditional stainless-steel system, the end user has significant control over the design, construction, qualification and validation, and maintenance of the system. When implementing a single-use system, the supplier of the single use product takes responsibility for many of these functions from the user. It is therefore important that the single use supplier has established and follows a strong quality control system. This presentation will highlight the quality systems, processes, facilities, and personnel required to assure the performance, robustness, and sterility of single use systems.
In this webinar you will learn:
- The process used to qualify components, suppliers and sub-suppliers
- Managing documentation control, change control, process particulate control, risk mitigation practices
- See examples of Extractables Testing, Validation of MFG processes, MFG Controls, Sterilization Qualification, Realease Testing and Certification, Integrity Assurance