Course Description:
In process development of a Pharmaceutical Continuous Manufacturing (PCM) oral solid dose (OSD) drug product, the goal is to identify all sources of variation and their impact on the quality of the final product. Implementing measures to properly mitigate or compensate variation will assure all product that goes to the patient is within pre-established quality specifications. This set of measures is called a control strategy and it considers the dynamic nature of a continuous process.
Measurement tools and models give a deeper understanding of process behaviors like viewing your process in a higher resolution. During this webinar you will learn why better control over quality is one of the many advantages PCM technology offers.
Sources of Variation
Excipients and API are never perfectly homogeneous: variations in characteristics like density, particle size distribution, humidity, can impact the quality of the final product. In a batch process these and other variations are blended in a bin blender to assure homogeneity and minimal impact. In a continuous process, this needs to be done in line with all the product and in a dynamic environment. In this webinar we will explain how homogeneity can be achieved in time.
Control Strategies
We will show what tools and measures to put in place to assure that a continuous line consistently produces high quality material, and properly separates material that is not within specifications. Having tools and sensors that generate valuable process data enables Real Time Release, and significantly reduces time between start of production and delivery to patients.
Topics:
Insight into how a continuous process differs from batch; what is needed to assure quality and achieve better process understanding
Who should participate:
Drug manufacturing, pharmaceutical manufacturing, biologics organizations; Job function: quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH. managers, scientists, 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.