Course Description:
In Pharmaceutical Continuous Manufacturing (PCM), technical solutions ensuring critical quality attributes for content uniformity (CU) and unit dose exist for on-line, in-line, and at-line measurements. What is the best way to integrate PAT-based devices, to select sensor technologies; what best-practice solutions exist to avoid complexity in Overall Equipment Effectiveness (OEE)? This webinar will address how to overcome operational challenges—providing an overview of the current state of this technology and its impact on control strategy and real-time release (RTR).
CU assurance within a PCM process
Common approaches to assure content uniformity for tablets
Control Strategy
Impact and examples of control strategies for content uniformity.
Current technical solutions
What built-in or auxiliary equipment is on the market; how to specify solutions, and what is missing.
Sensors
What sensor technologies are applicable and where are they most effective: in-line, online, at-line.
RTR strategy
A review of elements that influence the control strategy for any PCM system, and alternative solutions.
Who should participate:
Drug manufacturing, pharmaceutical manufacturing, Quality, managers, scientists, engineers, OSD, direct product, quality, CDMOs / CROs
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.