Category: Sterility Testing
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…
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…
Internationally Recognized Stability Criteria
With the 2019 revision to <797>, the USP eliminated the ability to extend Beyond Use Dates (BUDs) using stability indicating methods, citing there was more…
Pharmacy Inspection Podcast Episode 33 – Tom Kupiec from ARL Bio Pharma
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/7518035/height/360/theme/standard/autoplay/no/autonext/no/thumbnail/yes/preload/no/no_addthis/no/direction/forward/” height=”” width=”100%” placement=”bottom” theme=””] This week we welcome Tom Kupiec to the podcast. Tom is the owner of ARL BioPharma in Oklahoma City,…
Pharmacy Inspection Podcast Episode 8 – Pharmetric Labs
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6107035/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”] HAPPY NEW YEAR! Welcome to 2018. In our 8th episode we speak with James Brown and Dr. Wayne Dehaven…