Evolution of USP<1058> updates and insights in regulations
Posted: Wed Jan 18, 2023 11:27 am
When: 25 January, 2023
The United States Pharmacopeia (USP) is the only major pharmacopeia with a general chapter dedicated to analytical instrument qualification (USP <1058>). This makes <1058> a globally significant regulatory reference. However, despite the significant changes with the 2017 edition of <1058>, 68% of laboratories have not updated their qualification procedures. Additionally, the USP has already started the process to initiate updates to <1058>, when many laboratories may not fully comply with the current edition!
This raises many questions about the role of the current <1058> general chapter and how it aligns with the recently issued 2nd Edition of GAMP 5.
Register to attend this presentation and learn...
- How USP <1058> aligns with GAMP 5
- Core elements of the <1058> instrument life-cycle framework
- Areas of <1058> the USP are exploring improvements in
For more information and to register click on the link below:
https://webinar.sepscience.com/form/evo ... egulations
The United States Pharmacopeia (USP) is the only major pharmacopeia with a general chapter dedicated to analytical instrument qualification (USP <1058>). This makes <1058> a globally significant regulatory reference. However, despite the significant changes with the 2017 edition of <1058>, 68% of laboratories have not updated their qualification procedures. Additionally, the USP has already started the process to initiate updates to <1058>, when many laboratories may not fully comply with the current edition!
This raises many questions about the role of the current <1058> general chapter and how it aligns with the recently issued 2nd Edition of GAMP 5.
Register to attend this presentation and learn...
- How USP <1058> aligns with GAMP 5
- Core elements of the <1058> instrument life-cycle framework
- Areas of <1058> the USP are exploring improvements in
For more information and to register click on the link below:
https://webinar.sepscience.com/form/evo ... egulations