Course Description:
This webinar will guide you through the expectations of regulators when filing a Pharmaceutical Continuous Manufacturing (PCM) process for an Oral Solid Dose (OSD) drug product. Starting from the difference between a batch and a continuous process we cover the impact of evidence that needs to be generated so that the quality of the released product is assured, and how this will evolve throughout the drug product lifecycle. FDA, EMA, ICH [Q13].
Development
A body of knowledge is generated during development that can be used as submission data if certain rules are followed. Many aspects of development interrelate with regulatory submission. When should you work with validated models? What details of control strategy and statistical methodologies used for sampling are important? What aspects of material variability should you consider?
Tech Transfer & Commercial Manufacturing
Comparability, scaling factors, stability data, the amount and size of validation batches, release strategy and potential use of Real Time Release (RTRT) are key regulatory discussion areas when moving into the commercial phase.
Post Launch
Sales volumes become clearer after the launch of a product, and often manufacturers want to extend runtimes to make the commercial manufacturing more effective. When more batches are produced, it may be necessary to update the process models used to inform health authorities.
Topics:
High level understanding of health authorities’ expectations when filing a PCM process for a OSD product.
Who should participate:
Drug manufacturing, pharmaceutical manufacturing, biologics organizations; global regulation. Job function: quality assurance (QA), quality control (QC), regulatory, operations managers, quality management, pharmaceutical quality directors, MHA, MPH. managers, scientists, process development, OSD, direct product, quality
Though this course is being made available on USP’s Education site, the course content was developed by Pharmatech Associates, a USP company. USP has not independently reviewed or verified the accuracy of the course content.