This course will focus on the current USP General Chapters <788> Particulate Matter in Injections and <1788> Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions as it relates to requirements for subvisible particle determination. In addition, USP General Chapter <787> Subvisible Particulate Matter in Therapeutic Protein Injections will be discussed as it relates to particle determination in protein formulations. The informational chapter USP <1787> Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections which provides background and rationale for sub-10µm characterization, will be discussed. Finally, visible particle determination and two new compendial chapters on the topic, USP <790> Visible Particulates in Injections and USP <1790> Visual Inspection of Injections will be addressed in this course. Participants will apply their knowledge to real-world scenarios and examples using the information found in USP chapters.
Upon completing this course you will be able to:
- Summarize various perspectives regarding particulate matter and injectable products.
- Describe particulate matter and subvisible and visible methods of determination.
- Apply lab configuration concepts and sample preparation methodologies to various real-world scenarios.
- Explain USP <1> Injections as it relates to USP <788> and <790>.
Who Should Participate:
- Manufacturing personnel
- Operations personnel
- Quality personnel
- Regulatory personnel
- Laboratory scientists and managers
- QA/QC staff
- Scientists with interest in particulate matter