Course Description:Particle determination for sterile injectable products has been required for more than 30 years; however, recent improvements in standard methods for sensitive protein products have brought changes and additional background information to the Compendial guidance. This course will discuss the current, USP <788> Particulate Matter in Infections and <1788> Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions, requirements for sub-visible particle determination. In addition, a discussion on the new USP General Chapter <787>Subvisible Particulate Matter in Therapeutic Protein Injections for particle determination in protein formulations and the informational USP Chapter <1787> Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections which provides background and rationale for sub-10µm characterization. A portion of the course will focus on visible particle determination and the two new Compendial chapters on the topic, USP <790> Visible Particulates in Injections and <1790> Visual Inspection of Injections
Upon completing this course you will be able to:
- Outline Perspectives Regarding Particulate Matter and Injectable Products
- Outline Particulate Matter Determination Methods, both subvisible and visible
- Apply lab configuration and sample preparation methodologies
- Relate USP chapter <1> Injections topics relevant to <788> and 790>
Who Should Participate:
- Manufacturing/Operations Personnel who are responsible for the inspection of injectable products.
- Quality and Regulatory Personnel who are responsible for the sampling inspection of inspected products or the review of inspection data, and those responsible for compliance with cGMP and regulatory filings associated with injectable products.