The Pharmacy Inspection podcast is a show dedicated to discussing issues and topics related to sterile and non-sterile pharmacy compounding and compliance with industry standards.
USP 795 Revisions
In this episode we go over some of the major changes in the revision to USP Chapter and what you need to potentially know if it becomes finalized.
Pharmacy Inspection Podcast 483 Friday #10 - Non-Viable Particles
In todays 483 we're going to be looking at non-viable particle counts otherwise and more accurately known as total particle counts and why they're so important. So let's take a look at the 483 observation first then we'll dive into it a little deeper.
Pharmacy Inspection Podcast Episode 49 - 483 Fridays # 9 - Bacterial Endotoxin Testing
In this weeks' 483 we're going to be talking about Bacterial Endotoxins and the testing related to endotoxins. Let's first take a look at the observation then we'll discuss what endotoxins are and why it's important to keep them out of your preparations.
Pharmacy Inspection Podcast Episode 48 - Sharing Stability Studies
I am going to be talking today about something that is maybe a little bit controversial, but has been brought up at the last public forum that USP had in regards to the appeals to 797, 795. And that’s talking about shared stability studies Or a shared database of stability studies that multiple pharmacies could share amongst themselves.
Pharmacy Inspection Podcast Episode 47 - 483 Friday #8
In this weeks 483 Friday we're going to be talking about the use of ungraded ingredients in pharmaceutical preparations. First, I'd like to show you a 483 where this was done, then we'll look at a case where non-USP ingredients led to real issues in patients where the drug product contained non-USP graded ingredients.
Pharmacy Inspection Podcast Episode 46 - HEPA Filtered Exhaust is Best Practice
This week Bryan discusses the use of a HEPA filter prior to exhausting out of a building with a non-sterile USP compliant room - Is it necessary?