Pharmacy Inspection Podcast

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 compounded sterile products; both in hospital and home infusion settings.  Greg has extensive experience with policy development, staff training, pharmacy management and regulatory compliance.  Currently, Greg is an Associate Director at SUNY Upstate Medical University.  He is involved with several projects related to USP and USP .  His oversight includes sterile compounding, hazardous compounding, and robotic/automated technologies. 

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).

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 to oversee compounding operations at a large health system.

In this episode of the pharmacy inspection podcast I go over some of the changes to USP in the latest revision to the chapter.

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.

Learning Objectives Discuss the importance of particulate in relation to microorganisms Explain why 0.5 micron and larger sized particles are of great importance Discuss 3 ways that we can minimize the number of particles in our cleanroom 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. In this 483 it's noted that there was an out of specification result for environmental monitoring samples. I've talked in a previous podcast and posts about viable particles, but this week let's focus on non-viables. In observation 2 under section "d" it talks about not further investigating sterility failures for two particular compounds. The investigation documentation did not include and evaluation of production batch record reviews, EM for hoods and rooms (non-viable or viable particulates, person

Learning Objectives Discuss the importance of low levels of endotoxins in parenteral preparations Discuss the limits for endotoxins for various routes of administration Discuss ways to control the levels of endotoxins in final preparations 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. First thing that should be talked about specific to this 483 is that we're dealing with preparations that are intrathecals or will be injected into the spinal fluid. One thing to know about intrathecal injections in particular is that they have a lower limit for endotoxins than other injections. When performing final testing for preparations one of the tests is a bacterial endotoxin test. This test is performed according to USP Chapter Bacterial Endotoxins Test. For parenterals that are not intended for

Learning Objectives Discuss the use of USP graded ingredients in pharmaceutical preparations and the importance Explain what prompted the FD&C act of 1938 to be enacted 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. Let's take a look at the first 483: In this 483 it looks like the use of grain alcohol was used to make several products. Of course, using everclear 95% is NOT a USP graded alcohol and is actually meant to be for consumption, but not as a pharmaceutical ingredient. So what's the difference of whether something is USP-graded and a substance that doesn't carry that same grade? First, USP graded ingredients are tested for a number of things including the stability of the ingredient itself. This is the major

Learning Objectives Explain the purpose of viable air sampling Discuss how conclusions can be made from the results of viable air sampling Happy Friday! 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. In this particular 483 viable air sampling was performed by a third party testing company for the purposes of re-certifying the cleanroom. Here's what the observation said: So if you're unfamiliar with viable air sampling, it's the type of sampling where you use a piece of equipment to draw in a known volume of air and impact the air on a plate of growth media to see if there are microorganisms in the air. This 483 states that a third party contractor had done the viable air sampling inside their ISO 5 engineering control or hood and in their ISO 7 buffer room. What's interesting here is that t

The learning objectives for this week’s 483: Discuss the engineering control requirements for handling and compounding with hazardous drugs List two agents that can be used to deactivate hazardous drugs Discuss the 4 steps required to properly remove hazardous drugs from surfaces and equipment 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 some compliance with USP Chapter . Let's take a look at the observation: There's quite a bit of information packed into this short paragraph. First, the 483 mentions that drugs are produced without providing adequate containment. This suggests that perhaps the firm wasn't using containment ven

The learning objectives for this week's 483: Explain the typical out of specification range of potency for many compounded formulations Discuss a type of testing that is both economical and scientifically sound Discuss the 5 elements of an SOP on potency testing should include 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. USP Chapter , Stability considerations in dispensing practice, only helps us look for signs of chemical instability (i.e. potency) but still gives us no interval to guide the frequency of potency testing that should be performed. USP Chapter says: Pharmacists should avoid ingredients and conditions that could result in

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.

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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Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!   SUBSCRIBE: You Tube   Stitcher   Anchor FM   iHeart   Spotify   Radio Public   Pocket Casts   over cast   Cast box   Podcast App   Breaker   Google Podcasts   iTunes   Podbean

Having issues controlling temperature in your cleanroom? Here's what NOT to do and what you should do... Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!   SUBSCRIBE: You Tube   Stitcher   Anchor FM   iHeart   Spotify   Radio Public   Pocket Casts   over cast   Cast box   Podcast App   Breaker   Google Podcasts   iTunes   Podbean