USP CHAPTER 1085, “GUIDELINES ON THE ENDOTOXINS TEST”
2.1 هزار بار بازدید -
3 سال پیش
-
Presented by Karen Zink McCullough
Presented by Karen Zink McCullough & Kevin L. Williams
The retirement of the FDA’s 1987 Guideline on LAL testing left a number of gaps in the written body of knowledge on LAL testing. Some of these gaps include Guidance on RSE: CSE standardization, Guidance on Training, Guidance on OOS test results, and Calculation of Endotoxin Limits. The proposed chapter 1085. Pharmacopeial Forum, provides information and recommendations on these topics and more. This seminar will provide an overview of the contents of this new informational chapter.
The retirement of the FDA’s 1987 Guideline on LAL testing left a number of gaps in the written body of knowledge on LAL testing. Some of these gaps include Guidance on RSE: CSE standardization, Guidance on Training, Guidance on OOS test results, and Calculation of Endotoxin Limits. The proposed chapter 1085. Pharmacopeial Forum, provides information and recommendations on these topics and more. This seminar will provide an overview of the contents of this new informational chapter.
3 سال پیش
در تاریخ 1400/07/30 منتشر شده
است.
2,120
بـار بازدید شده