Regulatory Talks: Finalization of USP

WEBINAR

The principle scientific liaison from the United States Pharmacopeia (USP) will clarify details regarding the first compendial general chapter, USP <665>, detailing a standard assessment and testing approach for qualification of plastic components and systems used in drug manufacturing. This discussion will focus on the shift to this new approach and the necessity to conduct previous compendial test methods.

The expert panel will examine USP <665> in relation to other plastic qualification approaches. This discussion will include details regarding shifting away from USP <661>, along with questioning the necessity of other related general chapter methods. Specifically, USP <661.1> and <661.2> will be highlighted, which are typically utilized for material characterization and drug packaging component characterization, respectively. In the end, you will be more confident in understanding what, how, and when best to utilize the new compendial USP <665> standard extractables test methods.

In this webinar, you will:

• Understand details regarding the first official compendial general chapter, USP <665> for plastic components and systems used in drug manufacturing
• Learn about the scope and justification to help you eliminate the need for previous testing methods which are no longer directly relevant
• Leverage expert knowledge and regulatory support to plan the best approach to transition to this new USP <665> compendial extractables testing standard