○ 금번 미국 USP에서 진행할 Quality Hour 7는 “USP’s new general chapter <665>: Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products” 입니다.

 

○ Webinar 주요 내용

• Learn about USP’s new general chapter <665>: Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products

• Understand risk assessment process

• Testing Requirement based on risk level

• Receive updates on the USP-NF, Reference Standards and other USP resources

• Identify USP staff and activities in Asia Pacific

 

○ 일시 : 11월 24일 (화요일) 오전 11시

 

○ 교육신청링크: https://usptraining.webex.com/usptraining/k2/j.php?MTID=t252519c4d2a4318075289e9e364ee820

 

○ 담당자 : USP김신환  shin.kim@usp.org

 

<USP용기 적합성 관련 내용 링크>

USP has proposed a new general chapter <665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products in Pharmacopeial Forum 46(5) [Sep.−Nov. 2020]. Log in to PF to access and comment by November 30, 2020->  https://online.usppf.com/usppf/document/GUID-F06B057E-8C4D-4F3F-8A5C-9C62012C7947_10201_en-US?highlight=665