Pharmacy Inspection Podcast

Pharmacy Inspection Podcast

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.

Episodes

April 15, 2022 32 min
Thanks for tuning in to the Pharmacy Inspection Podcast! Today we have Pharmacist Greg Stanley on the show and we're going to be talking about implementation of an IV workflow system! Greg Stanley received his Bachelor of Science in Pharmacy degree in 1998, having also completed undergraduate research fellowships in Biological/Environmental Sciences and Polymer Sciences.  He has over twenty-five years of experience with compoun...
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In this weeks episode we welcome Bryan Prince back to the show to talk about cleanrooms. We discuss common issues that we see with cleanrooms, talk about particle counts and certification reports as well as some cool technology being used to simulate a cleanroom before it's even built (computational fluid dynamics - CFD).
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Today on the podcast we welcome Lilit Smith. Lilit is a board certified sterile compounding pharmacist and is currently the Manager of Compounding and Compliance at Baptist Health South Florida. In her role she supports across the pharmacy enterprise with cleanroom design and construction, regulatory compliance and process and policy standardization. We're going to be talking about her experience with building a compliance team...
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November 26, 2021 29 min
In this episode of the pharmacy inspection podcast I go over some of the changes to USP in the latest revision to the chapter.
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October 8, 2021 18 min
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.
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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.
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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.
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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. 
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October 9, 2020 12 min
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.
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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?
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October 2, 2020 13 min
This weeks 483 we're going to focus on viable air sampling, which is one part of an environmental sampling plan. The information gained from viable air sampling can be very telling of the cleanliness and control you have over your cleanroom.
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Bryan will be talking about some of the unintended consequences of implementing USP 800 and this particular story he is going to tell you was incredibly expensive...
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September 25, 2020 8 min
In this week's 483 we're going to look at the importance of cleaning work and non-work surfaces to prevent cross-contamination. What's interesting about this particular 483 is that the FDA doesn't note this on sterile products, but an operation's non-sterile compounding areas. Also, the 483 specifically mentions "hazardous drugs," so there should be no question in your mind whether the FDA is looking for...
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This week we'll be looking at one observation the FDA made at a facility concerning the potency testing of their drug products. While there's not much direction given to pharmacies through USP Chapter , there's still a need for testing this critical attribute of our preparations. In fact, doesn't give us any requirements for testing for potency or the interval at which we should test our preparations.
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In this week’s 483 we’re going to talk about investigating microbial contaminations inside the cleanroom to find out possible sources and remediate the issue. We’re also going to talk about writing up that investigation and the resulting corrective action/preventive action or CAPA as a result.
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September 12, 2020 11 min
Learning Objectives Explain how action levels are used to maintain a controlled environment Define the 5 steps to DMAIC Explain the 5 why's technique for finding a root cause Discuss the proper documentation for documenting a deviation In this week's 483 we're going to talk about investigating microbial contaminations inside the cleanroom to find out possible sources and remediate the issue. We're also going t...
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Bryan lays out two mistakes that he recently came across in a very well designed 3D model of a cleanroom...the only problem, there were two fairly critical mistakes. Don't make these mistakes...
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Are you paying too much for viable sampling when you certify your cleanroom? This week we discuss how the lack of guidance for viable sampling is potentially costing you!
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This week we discuss Environmental Sampling Plans…who should be deciding where and how to sample at your facility?
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Bryan discusses the proper materials of construction for a USP compliant cleanroom
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