Successful process performance qualification (PPQ) and commercial launch requires planning well before manufacturing registration batches. This webinar is the first of a 2-part series. The series will focus on the recommended studies from a technical transfer group perspective that should be conducted pre-product registration and post-registration to ensure a reproducible and scalable manufacturing process during PPQ and commercial launch.
This first part of the webinar series will focus on studies for pre-registration activities. Registration manufacturing is critical to a product’s regulatory filing, creating the proposed process for commercial manufacturing. While some changes can be made to the process post-registration, the level of change and subsequent studies (both engineering and clinical) can be costly and severely impact the timeline to launch a product. Through the use of risk-mitigation techniques and understanding regulatory requirements upfront, critical studies can be identified prior to registration manufacture that will de-risk the scale-up process.
Do you have questions about process performance qualification or tech transfer in general? Are you wondering what steps you need to take to ensure successful registration manufacture and commercial launch?
