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.
Subject area:
Drug Products & APIs
Objectives (If applicable):
• Summarize subvisible and visible particulate matter determination methods.
• Describe various perspectives regarding particulate matter and injectable products.
• Explain lab configuration and sample preparation methodologies for particulate matter.
• Identify USP chapter <1> Injections topics which are relevant to chapters <788> and 790>.
• Discuss guidance from the USP informational chapters which relate to the particle identity.
Target Audience (If applicable):
Manufacturing personnel
Operations personnel
Quality personnel
Regulatory personnel
Laboratory scientists and managers
QA/QC staff
Scientists with interest in particulate matter