Can we share Stability Studies?
I received this question this week: What do you think about sharing a stability study with another pharmacy? Would that be acceptable? I tried to…
Category: Aseptic Technique
FDA to USP: Sterility is top concern with extended BUDs
Tomorrow, September 15, 2020, the USP will be having a call for comments regarding the appeals related to extending Beyond Use Dates in USP Chapter…
Ending confusion – Endotoxins to Endospores
Endotoxins or Endospores? At one point I was a little mixed up by these two very different terms. They start with the same prefix; they’ve…
483 #3 – Smoke Studies and Media Fills
Learning Objectives Explain the purpose of smoke studies Define the two types of smoke studies that need to be performed Explain the two conditions under…
Getting an FDA “Close Out Letter”
An FDA Inspection So you’ve been visited by the FDA and whether you’re a seasoned QA manager at a major pharmaceutical manufacturer or the pharmacist…
483 #1 – Aseptic Technique 101
Learning Objectives: Discuss proper ways to compound inside the primary engineering control and potential risks of having exposed skin while compounding Explain what must be…
Pharmacy Inspection Podcast Episode 27 – RECORDED – USP 797 Proposed Revision with Jon Pritchett
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6870619/height/360/width/450/theme/standard/autonext/no/thumbnail/yes/autoplay/no/preload/no/no_addthis/no/direction/forward/” height=”360″ width=”450″ placement=”top” theme=”standard”]Thanks SO so much for everyone that did tune in; I promise next live event I will DEFINITELY RAISE THE…