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.
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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 <797> and USP <800>. 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.
52 // 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....
52 // USP revision updates
In this episode of the pharmacy inspection podcast I go over some of the changes to USP in the latest revision to the chapter....
50 // Pharmacy Inspection Podcast 483 Friday #10 – Non-Viable Particles
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, personnel monitoring, press plates), cleaning logs for the room, qualification of the hoods, retain samples or previous OOS. FDA 483 Observation 2 So why does it mention specifically looking at non-viable samples, aside from all of the others? Let’s take a quick look at a table that’s from USP , which is actually from an international document, ISO 14644. I’m sure you’ve seen this before but if you haven’t here it is. But what exactly do all of these numbers mean and why are they so important? In the left column you have ISO classes which are the classes of different areas of the clean room. Your primary engineering controls or your hoods are typically ISO class 5 and your secondary engineering controls or your room are typically ISO class 7 or you may have an anteroom that’s ISO class 8. In the right hand column you have the limits of the particle counts per cubic meter, meaning if you have particle counts higher than the numbers in this column corresponding to the particular ISO class that area fails and cannot be classified as such. One thing to note here, at the bottom of the table in small writing it specifically mentions the numbers pertain to particles of a particular size 0.5 micron or larger. Why are 0.5 micron sized particles of importance? Well, there’s one thing you should know about microorganisms. Rarely are microorganisms free floating by themselves. They actually travel on particles, and if you haven’t already guessed they’re usually attached to particles that are 0.5 micron or larger. One other interesting point worth mentioning and this may seem like common sense but the larger the particle, the more dense it is and the heavier it is. These larger sized particles are the ones that tend to settle on surfaces. Smaller, lighter particles can stay free floating in the air but it’s the job of our engineering controls to push them away from our critical areas and hopefully push them down toward the ground where they’re not a threat to our preparations. Now, if you have high particle counts in your cleanroom or primary engineering control does that mean that every one of those particles has a microorganism attached to it? No, not necessarily. However, taking particle counts is a great, general way of looking at the state of cleanliness of your cleanroom. Another question is, do we know the percentage of particles that have microorganisms attached to them? To be completely honest, I’m not sure if there’s been a study done to make that correlation but one thing that’s for certain is that the higher the particle counts in your classified areas, the higher the chance for contamination. One point I really want to drive home is that when we get our cleanroom certified and we’re looking at the numbers of particle counts, you can glean a lot of information from that report. If you have high particle counts in a particular area, you can look inside you
49 // Pharmacy Inspection Podcast Episode 49 – 483 Fridays # 9 – Bacterial Endotoxin Testing
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 intrathecal administration the limit is 5 EU/kg (Endotoxin Units). For intrathecal injections the limit is 0.2 EU/kg. The per kilogram is the weight of the patient. The fact that there is a much lower limit of endotoxin specifically for intrathecal injections should give an indication as to the importance of having very low levels of endotoxin in the final preparation. This particular pharmacy is probably compounding the intrathecal in either very low batch sizes (less than 5) or one at a time as they’re ordered by a physician. By not batch compounding the intrathecals there’s not enough of the final preparation to send off for testing. My guess is that these are being made one at a time per order and are delivered to be administered within 24 hours. What are Bacterial Endotoxins and where do they come from? Most common, endotoxins are by-products of the gram negative bacterial cell lysis. They are lipopolysaccharides that make up part of the cell wall. Gram negative bacteria are commonly found in water sources. So if at any point you are using water either in the preparation itself or using materials that have been washed (i.e. glassware), there is a very high risk of having bacterial endotoxins in the preparation if there aren’t any controls in place to limit the level of bacterial endotoxins. If glassware is being washed and re-used for processing the preparation, the glassware should go through a depyrogenation cycle meaning they would be held at a temperature of 250 degrees celsius for a minimum of 30 minutes. The time may vary depending on the glassware and oven that’s being used for the depyrogenation process. Depyrogenation cycles of glassware should be validated to show that the process of depyrogenation is producing a 3-log reduction in bacterial endotoxins. Even if the process for limiting endotoxins in glassware in place you still need to consider any of the raw materials you’re using (i.e. the active pharmaceutical ingredient or API). Water is used quite frequently in the manufacturing of pharmaceutical ingredients and the certificates of analysis for your API should include the limit for endotoxin and the results of testing for endotoxins. It’s pointed out in this 483, that the certificates of analysis (COAs) do not include results of endotoxin limits for the APIs. Why are Endotoxin limits so critical? When a sufficient amount of endotoxins are injected this could result in a fever or can be as severe as death; particularly if injected into the spinal fluid where there is no immune system. Since this pharmacy doesn’t have COAs that show the endotoxin results and are not testing for endotoxin in their final preparation, they really have no way of showing that their intrathecal injections are meeting the required limits for endotoxins. There are several ways that this pharmacy could increase the level of assurance that their process is limiting
48 // Pharmacy Inspection Podcast Episode 48 – Sharing Stability Studies
Pharmacy Inspection Podcast Episode 48 – Sharing Stability Studies...
47 // Pharmacy Inspection Podcast Episode 47 – 483 Friday #8
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 difference between those ingredients that carry the USP grading and those that do not. First, is there such a product that exists for this pharmacy? Are there USP graded ethanols that could’ve been used in this product? The answer is yes. There is in fact a USP monograph for ethanol which typically means that alcohol USP can be found in the market that’s been tested for impurities and degradation products. So the easiest way to solve the issue for this pharmacy is to simply use USP graded 200 proof alcohol. I would like to note that in this particular 483 it’s noted that this pharmacy is a “Producer of Non-Sterile Drug Products”. So one thing I can say is that all of their products were being used for topical use and not to be consumed. Nonetheless, the alcohol used was not USP-graded so the point that the final preparation wasn’t consumed orally or by given by injection still doesn’t necessarily matter. The next question in my mind, if there is no substitute for something that is intended to be laboratory grade, is there a way to qualify this ingredient for use in your drug product. I would say yes, however much research and testing would need to be done prior to its use. How to go about doing that goes beyond what this episode will cover but the possibility is there. Next, let’s look at a scenario where using non-USP graded ingredients were used in an injection and actually caused harm to the patient. In 2017, there were two infusions of curcumin compounded with non-USP graded polyethylene glycol (PEG) 40 castor oil. As a result when these injections were administered patients had hypersensitivity reactions to the IV product. Note that in this preparation it actually was administered intravenously, so this was a sterile product. So what happened to these patients and why? The FDA reports: On March 10, 2017, the U.S. Food and Drug Administration received an adverse event report concerning a 30-year-old female patient who experienced cardiac arrest after IV administration of a curcumin emulsion product…The patient reportedly had a history of allergies and was being treated for eczema by a naturopathic doctor. Within minutes of starting the infusion, the patient became pulseless and required CPR. The patient suffered anoxic (depleted oxygen) brain injury and subsequently died. An adverse reaction to infused curcumin solution was identified as a cause of death by the local authorities. FDA investigates two serious adverse events associated with…compounded curcumin emulsion product for injection In a second case where this drug was administered the FDA reports: On May 1, 2017, FDA received an adverse event report concerning a 71-year-old male patient who developed a hypersensitivity reaction after IV administration of (name of facility removed) compounded curcumin emulsion product. The patient had a history of allergies and was being treated for thromb
46 // Pharmacy Inspection Podcast Episode 46 – HEPA Filtered Exhaust is Best Practice
Pharmacy Inspection Podcast Episode 46 – HEPA Filtered Exhaust is Best Practice...
45 // Pharmacy Inspection Podcast 45 – 483 Friday #7 – Viable Air Sampling
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 the 483 shows the results from not one certification of their cleanroom but the inspector reported a second certification six months later as well. What’s most concerning is the April 2019 results where a total of 19 CFU or colony forming units were found. However, six months later, while there was still microorganisms found in the air in the same location, it was much less with only one found. Let’s continue to just focus on the ISO 5 location as this is the most critical part of the cleanroom as this is where the compounding is performed. In either case, April and October, an investigation should have been done in the cleanroom to figure out what the underlying issue is. I encourage you to go back and listen to the podcast episode on Investigations and CAPAs for learning how to properly investigate and document microbial excursions. In this 483, because it was a third party contractor, they also reported the type of organisms present. This can be extremely helpful in finding out the root cause of the contamination. In April, 19 CFU were found and they were: Bacillus Coagulase negative Staphylococcus Micrococcus USP Action levels for viable air sampling There’s actually a chart within USP that tells us when we should take action if there’s greater than 1 CFU found to be in our ISO class 5 area. So the fact that in April there were 19 found, an investigation absolutely should have been performed. Looking up where these particular microorganisms come from would be the first step in an investigation. Bacillus are gram positive bacteria that are usually able to form spores, which are highly resistant when they’re in their spore form. Bacillus can be found in soil or can be of animal origin. Coagulase negative staphylococcus and micrococcus are typically normal flora found on humans. This information gives us two possible places to look for ingress routes for these organisms: materials and people or operators inside the cleanroom. Remember, these were found in their ISO class 5 engineering control which is supposed to be extremely clean and free of microorganisms at any given time. So this could also suggest that maybe there’s something wrong with their engineering control as well as it should be actively pushing microorganisms out of the hood. In an investigation, we would possibly look at: Gowning procedures for operators Cleaning procedures: what agents are being used, the frequency of cleaning Operator technique while inside the cleanroom Our process for bringing materials into the cleanroom The engineering control itself: is it working properly, is there enough airflow, is there anything wrong with the HEPA filters Six months later when the recertification was done again, there was only 1 CFU of bacillus found in the ISO 5 hood. This suggests that the firm did possibly investigate the cause of the contamination and made some im
44 // Pharmacy Inspection Podcast 44 – Is my building right for my pharmacy compounding
Episode 44 – Is my building right for my compounding pharmacy?...
43 // Pharmacy Inspection Podcast 43 – 483 Friday – Cross-Contamination
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 ventilated enclosures or powder hoods while compounding. They are also cited for having non-dedicated utensils and equipment for compounding with hazardous drugs. The hazardous drug in this case being tretinoin. USP specifically talks about non-sterile compounding and the requirements that must be followed: The C-PECs used for manipulation of nonsterile HDs must be either externally vented (preferred) or have redundant–HEPA filters in series. USP Chapter Non-sterile Compounding USP Chapter Engineering Control Requirements for Non-sterile Compounding This table, taken directly from USP , gives the required engineering controls for when you’re compounding with hazardous drugs. First, HDs should be inside an externally vented room or secondary engineering control that has at least 12 air changes per hour and a negative pressure between -0.01 and -0.03 inches water column. Also, the compounding must be performed inside an externally vented primary engineering control or it must have redundant-HEPA filters in series. Next, let’s talk about the use of dedicated equipment and utensils. If you’re compounding with hazardous drugs, all of the materials and equipment you use should be dedicated specifically for HDs and not be used for non-HD compounding. USP mentions this specifically here: Disposable or clean equipment for compounding (such as mortars and pestles, and spatulas) must be dedicated for use with HDs. USP Chapter 13. Compounding Above this paragraph in it also mentions: Clean equipment should be dedicated for use with HDs and should be decontaminated after every use. USP Chapter 12. Dispensing Final Dosage Forms Even the 483 talks about cleaning utensils, specifically citing that, …you do not use deactivating agents for the removal of hazardous ingredients on shared utensils. FDA 483 What agents specifically is the agency talking about when they mention the term “deactivating agent”? A deactivating agent is one that renders the hazardous drug or residue inert. The specific agents that deactivate HDs are oxidizing agents, such as peroxide formulations or sodium hypochlorite. Here’s another table from USP that talks about all of the steps that need to take place to properly deactivate, decontaminate, clean and disinfect items or surfaces that may have come in contact with hazardous drugs. USP Chapter Cleaning Steps So this applies not just to your surfaces that you’ve potentially contaminated with hazardous drugs, but any of the equipment and utensils used as well. While the FDA may not specifically cite you for something where they quote directly out of USP they’re still concerned with cross-contamination between products. Even trace amounts of hazardous drugs in other formulations is just not acceptable. If you’d like a more in-depth post on the procedure specifically for cleaning up a hazardou
42 // Pharmacy Inspection Podcast 42 – 483 Friday – Potency Testing
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 excessive physical deterioration or chemical decomposition of drug preparations, especially when compounding…Pharmacists should establish and maintain compounding conditions that include the ensuring of drug stability to help prevent therapeutic failure and adverse responses. USP Chapter , Stability Considerations in Dispensing Practice Throughout the rest of USP , it talks about what can cause chemical instability and the signs you should look for in particular dosage forms. However, even gives no direction on how frequently potency should be tested on sterile preparations Observation 8 Going by this 483 observation, the FDA would like to see: A plan in place for how frequently you’re testing your preparations for potency The acceptable criteria for potency (less or greater than 10% loss/gain of potency) Written SOPs for the frequency and criteria of your potency testing program Written SOPs for what to do when a preparation falls out of specification for potency So how do compounders come up with a frequency for testing their batches for potency? In manufacturing there’s a concept known as “skip lot” testing for critical attributes of products for processes that are under a state of control. However, the manufacturer must justify this decision to perform skip lot testing. In an FDA Guidance, “Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances” the FDA gives details on what attributes could be chosen for skip lot or periodic testing: Data generated during product development may be sufficient to justify skip lot testing or elimination of some or all attributes from the specification. Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances There’s no debate on whether potency testing will give extra assurance that your product/preparation is of the purported and expected potency which in turn ensures the safety of the preparation for the patient. However, cost does become a factor as extra testing increases the cost of a batch and will be passed on to the patient. I’d like to suggest a scientifically and statistically sound procedure for determining how often compounders test for potency. Let’s talk about what you would want to have in an SOP that dictates potency testing for your compounded preparations (sterile or non-sterile). The SOP should consist of:3 Verifying that the compounded preparation is correct at the start of the program by appropriate potency testing in an independent quality control lab. Choosing a sampling interval, which will define the maximum out of specification (OOS) limits that will be detected (Surprisingly, these intervals can be relatively long. For example a failure rate greater than 5.5% should be detected if every 25th lot (or batch) of a preparatio
41 // 483 Friday – Investigations & CAPAs 9-11-20
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.
40 // Pharmacy Inspection Podcast – Episode 40 – Cleanroom design mistakes you shouldn’t make
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…
39 // Paying too much for viable sampling
Paying too much for Viable Sampling...
38 // Environmental Sampling Plans
Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!...
37 // Materials of Construction
Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!...
36 // holes in my cleanroom?
Having issues controlling temperature in your cleanroom? Here’s what NOT to do and what you should do…...
35 // Architects, Engineers & the case of the missing mini-split…
Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!...
34 // Pharmacy Inspection Podcast Episode 34 – Viable Air Sampling
This week we welcome Brenda Jensen and Jim Hack of Compounding Consultants to the podcast. They both began their pharmacy careers as technicians over 30 years at an Air Force... Base and now consult pharmacies, large and small, in compounding compliance for seeking accreditation. We’ll be having a discussion on compliance with USP , specifically about viable air sampling.
33 // Pharmacy Inspection Podcast Episode 33 – Tom Kupiec from Analytical Research Laboratories
This week we welcome Tom Kupiec to the podcast. Tom is the owner of ARL (Analytical Research Laboratories) Oklahoma City, Oklahoma....
32 // Pharmacy Inspection Podcast Episode 32 – Kim Kieffer USP Chapters OTHER THAN 795, 797 & 800!
This week we welcome Kim Kieffer to the podcast. Kim is the Director of Corporate Relations at Empower Pharmacy in Houston Texas. She’s been a compounding consultant at Spectrum, Letco... and Freedom Pharmaceuticals. Most recently she was the Academy Manager at Fagron educating pharmacists and technicians. She has a wealth of knowledge when it comes to formulations and quality control. This week we discuss various, lesser known USP chapters (other than USP 795, 797 and 800) and their application(s) to compounding.
31 // Pharmacy Inspection Podcast Episode 31 – Melissa Stefko
This week we welcome Melissa Stefko, from Wells Pharmacy Network to the podcast. Melissa Stefko, Senior Director of Quality for 503B Wells Pharmacy Network, will be discussing contamination control as it... relates to pharmaceutical compounding. Ms Stefko is an experienced Pharmaceutical and Biotechnology professional with a background in Quality Assurance and Quality Control in aseptic sterile processing.
30 // Pharmacy Inspection Podcast – Episode 30 – USP Designated Person
This week Greg Stowell and Jon Pritchett from PCAB (ACHC) speak with us about a new course they’ve released that teaches you all about becoming compliant with the Designated Person... requirement within USP 800.
29 // Pharmacy Inspection Podcast Episode 29 – Process Improvement
This week Bryan and I talk about Process Improvement! We give specific examples of how to start out improving a few processes within your own pharmacy. ...
28 // Pharmacy Inspection Podcast Episode 28 – Bryan and Seth talk Compounding Design Theory
This week Bryan and I talk about Compounding Design Theory! This podcast stemmed from a conversation Bryan and I had about a hood that he helped design for Encore Scientific (pictured... on left); a hood with a clear view from any angle. Which is extremely helpful from the the perspective of the PIC; who at any moment could be doing any number of things in the lab. With a hood like this they’re able to maintain visibility of any of the technicians operating inside which is important just from quality standpoint but ALSO for the technician working inside as well.
27 // Pharmacy Inspection Podcast Episode 27 – RECORDED – USP 797 Proposed Revision with Jon Pritchett
Thanks SO so much for everyone that did tune in; I promise next live event I will DEFINITELY RAISE THE BAR!!! I’ve fixed most of the audio issues and I... believe we’ll revisit this conversation again the very near future! LAST WEEK USP announced the proposed revisions of 797. Join Jon Pritchett, Bryan Prince and I for a SPECIAL EDITION of the Pharmacy Inspection Podcast where we’ll discuss some of the changes that may impact you if accepted.
26 // Pharmacy Inspection Podcast Episode 26 – Vitae Industries (AutoCompounder 3D Printer!)
This week we broadcast our interview that we recorded at CCH in June. Bryan was able to sit down with Jeanine Sinanan-Sing, co-founder and CEO of Vitae Industries, maker of the... AutoCompounder 3D printer . They talk about their platform and the exciting possibilities available with its use.
25 // Pharmacy Inspection Podcast Episode 25 – Kim Kieffer
This week we welcome Kim Kieffer! Kim is the Director of Corporate Relations at Empower Pharmacy in Houston Texas. She’s been a compounding consultant at Spectrum, Letco and Freedom Pharmaceuticals.... Most recently she was the Academy Manager at Fagron educating pharmacists and technicians. She has a wealth of knowledge when it comes to formulations and quality control.
24 // Pharmacy Inspection Podcast – Episode 24 – Christine Roussel
This week we welcome Christine Roussel, assistant Director of Pharmacy at Doylestown Hospital in Pennsylvania and Program Facilitator for Medisca’s LP3 Network. This was a great conversation about containment practices... and we really hope to have her on again sometime soon!
23 // Pharmacy Inspection Podcast – Episode 23 Greg Stowell
This week we welcome Greg Stowell, Education and Consulting Manager for Accreditation University. We discuss how ACHC is helping to bring continuous quality education to compounders. ...
22 // Pharmacy Inspection Podcast – Episode 22 (795 discussed)
On April 20th the USP had an online open forum where they discussed the proposed revision of 795. Today on the show Bryan and Seth discuss some of the proposed... changes to 795.
21 // Pharmacy Inspection Podcast Episode 21 – Lauren Bernick
This week we welcome Lauren Bernick, Director of Advertising for the International Journal of Pharmaceutical Compounding. Lauren also runs a website called wellelephant.com, where she consults on nutrition using a... whole foods, plant based diet. This week we talk about how compounders could expand their business and brand using nutrition/wellness and help people live a healthier lifestyle in the process.
20 // Pharmacy Inspection Podcast Episode 20 – Endotoxin vs Endospores
This week Bryan and I discuss the differences between endotoxin and endospores; diving a little deeper into the post from last week. We talk about the basics of these two,... why they’re important and how to kill or deactivate them.
19 // Pharmacy Inspection Podcast Episode 19 – Donnie Calhoun
This week we welcome Donnie Calhoun, Pharmacist, Pharmacy owner and CEO & Executive Director for the American College of Apothecaries (ACA). Donnie brings a lot of experience and knowledge to... the podcast this week as we discuss the topic of education within compounding including the future of pharmacy and the ACA’s role in providing pharmacists with quality education.
18 // Pharmacy Inspection Podcast Episode 18 – Denise Frank
This week we welcome Denise Frank, Pharmacist, Consultant, Educator…within compounding Denise has done a LOT! We met Denise at the ACA meeting in Florida and had to have her on... the podcast. Denise has also worked for the National Associations of Boards of Pharmacy and helped developed the program for how they inspect compounding pharmacies.
17 // Pharmacy Inspection Podcast Episode 17 – Erika Fallon of Fallon Wellness Pharmacy
This week we welcome Erika Fallon, Supervising Pharmacist at Fallon Wellness Pharmacy to the podcast. Erika is heavily involved in the International Academy of Compounding Pharmacists as she is on their... Board of Directors and also sits on the legislative committee as well.
16 // Pharmacy Inspection Podcast Episode 16 – Bryan and Seth talk PPE
This week Bryan and I discuss proper donning and doffing of Personal Protective Equipment (PPE) – there seems to be much discussion this topic and how to perform properly when... it comes to hazardous drug handling. Honestly, I think this is still open for debate on how to do correctly and maybe there’s more than 1 way to get it done.
15 // Pharmacy Inspection Podcast Episode 15 – Bill Fixler part 2
In our 15th episode Pharmacist and rockstar entrepreneur, Bill Fixler talks about his experience in co-owning 3 pharmacies; all of which compound. Most recently, Bill has been working on opening... a 503B pharmacy, Asteria Health in Birmingham, Alabama. We also discuss differences between owning a 503A and 503B and what he learned making this transition. This is the second part of possibly a three part series that we recorded last year.
14 // Pharmacy Inspection Podcast Episode 14 – Herschell Hitchcock
This week we welcome Herschell Hitchcock, President of EOC1 to the podcast. Herschell is an industrial hygienist by training and has a ton of experience in how exactly cleanrooms work... and how to troubleshoot problems when something goes wrong. His company EOC1 also certifies and maintains cleanrooms for a number of clients all over the United States and beyond!
13 // Pharmacy Inspection Podcast Episode – Brenda Jensen and Jim Hack
This week we welcome Brenda Jensen and Jim Hack of Compounding Consultants to the podcast. They both began their pharmacy careers as technicians over 30 years at an Air Force... Base and now consult pharmacies, large and small, in compounding compliance for seeking accreditation. WE’RE NOW ON iHEART RADIO PODCASTS.
12 // Pharmacy Inspection Podcast Episode 12 – Dr. Loyd Allen Jr.
This week we welcome Dr. Loyd Allen Jr. to the podcast. He is the editor-in-chief of the International Journal of Pharmaceutical Compounding (click here) and has been an outspoken advocate for... improving quality in compounding as well as advising on multiple committees for the United States Pharmacopeia and the FDA. WE’RE NOW ON iHEART RADIO PODCASTS (click here)! Sign up for updates from PharmacyInspection.com: [mc4wp_form id=”14886″] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We’re just getting warmed up; there’s SO many more topics to cover! Stay tuned for what’s to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!
11 // Pharmacy Inspection Podcast Episode 11 – Java Coleman
Java Coleman joins us this week. He is a consultant for the pharmaceutical industry through XLN Collaborative Consulting. Java has been working for many year now in the area of... process improvement. He’s also worked at large organizations like Fagron, Apex and Nestle in their operations and improvement divisions. Feel free to reach out to Java: firstname.lastname@example.org WE’RE NOW ON iHEART RADIO PODCASTS (click here)! Sign up for updates from PharmacyInspection.com: [mc4wp_form id=”14886″] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We’re just getting warmed up; there’s SO many more topics to cover! Stay tuned for what’s to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!
10 // Pharmacy Inspection Podcast Episode 10 – Rad Dillon
This week we talk with Rad Dillon. He is a pharmacist and certified surveyor and consultant for the Accreditation Commission for Health Care with a lot of experience performing PCAB... accreditation audits. Rad also has experience in writing Standard Operating Procedures and pharmacy management. He’s also attained the American Society for Quality’s Quality Auditing (CQA) and Quality Management/Operational Excellence (CMQ OE) certifications. Sign up for updates from PharmacyInspection.com: [mc4wp_form id=”14886″] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We’re just getting warmed up; there’s SO many more topics to cover! Stay tuned for what’s to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!
9 // Pharmacy Inspection Podcast Episode 9 – Joe Cabaliero and Bill Mixon
In our 9th episode we speak with Joe Cabaliero and Bill Mixon. Both of these gentlemen have a history in compounding pharmacy that is interesting and impressive. Recently, they have... submitted a proposal to include sterile compounding as one of the Board of Pharmacy Specialties (BPS). In this episode we discuss how the idea came about and some of the work that went into getting the specialty to be considered. Sign up for updates from PharmacyInspection.com: [mc4wp_form id=”14886″] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We’re just getting warmed up; there’s SO many more topics to cover! Stay tuned for what’s to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!
8 // Pharmacy Inspection Podcast Episode 8 – Pharmetric Labs
HAPPY NEW YEAR! Welcome to 2018. In our 8th episode we speak with James Brown and Dr. Wayne Dehaven of Pharmetric Laboratory. We’ll be talking about the importance of method... suitability, why it’s necessary and what Pharmetric specializes in: Rapid Microbiological Sterility Testing. Their method allows pharmacies to get sterility results within 5 days rather than 2 weeks. Sign up for updates from PharmacyInspection.com: [mc4wp_form id=”14886″] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We’re just getting warmed up; there’s SO many more topics to cover! Stay tuned for what’s to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!
7 // Pharmacy Inspection Podcast 7 – Jon Pritchett
In our 7th episode we speak with Jon Pritchett, Associate Director of Pharmacy for Accreditation Commission for Health Care. Jon has not only worked in compounding pharmacy for many years but... is now director of pharmacy of the accrediting body that audits many compounding pharmacies throughout the country. This is a great discussion about USP 800, Accreditation University and their offerings and we try to answer the question, “why are there so many awesome pharmacists in the state of North Carolina?” Sign up for updates from PharmacyInspection.com: [mc4wp_form id=”14886″] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We’re just getting warmed up; there’s SO many more topics to cover! Stay tuned for what’s to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!
6 // Pharmacy Inspection Podcast Episode 6 – Bill Fixler
In our sixth episode Pharmacist and rockstar entrepreneur, Bill Fixler talks about his experience in co-owning 3 pharmacies; all of which compound. Most recently, Bill has been working on opening... a 503B pharmacy, Asteria Health in Birmingham, Alabama. We also discuss differences between owning a 503A and 503B and what he learned making this transition. This podcast is a little longer than our previous; our whole conversation with Bill was well over 90 minutes; I’ll make this entire conversation available to my subscribers shortly because there is a TON of valuable information! Sign up to receive the entire episode: [mc4wp_form id=”14886″] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We’re just getting warmed up; there’s SO many more topics to cover! Stay tuned for what’s to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!
5 // Pharmacy Inspection Podcast Episode 5 Cheri Kraemer
In our fifth episode we welcome Cheri Kraemer, owner and pharmacist in charge of Pharmacy Specialties, Inc. Cheri has been compounding for many years and was recently distinguished by ACHC... for the pharmacy’s compliance with USP 800. On this episode we’ll be talking with Cheri about the challenges she faces with 800 and just generally with the changing landscape of compounding pharmacy. If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We’re just getting warmed up; there’s SO many more topics to cover! Stay tuned for what’s to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!
4 // Pharmacy Inspection Podcast Episode 4
In our fourth episode we welcome back Shawn Valandra, owner of SV Environmental Consulting and SVE Filtration. Shawn has experience in providing clean air solutions to GMP Environments for the... last 20 years. Bryan Prince and Shawn have consulted on and built several USP compliant cleanrooms. We continue our discussion on various issues that pharmacies will typically see with building new cleanroom environments. We also talk about some of the obstacles they’ve encountered on projects they were called on to finish. If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We’re just getting warmed up; there’s SO many more topics to cover! Stay tuned for what’s to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!
3 // Pharmacy Inspection Podcast Episode 3
Show Notes In our third episode we welcome Shawn Valandra, owner of SV Environmental Consulting and SVE Filtration. Shawn has experience in providing clean air solutions to GMP Environments for... the last 20 years. Bryan Prince and Shawn have consulted on and built several USP compliant cleanrooms. We discuss various issues that pharmacies will typically see with building new cleanroom environments. We also talk about some of the obstacles they’ve encountered on projects they were called on to finish. When we recorded this it actually went a little long so we turned this conversation into a two part series, check out the conclusion of this discussion in episode 4. If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We’re just getting warmed up; there’s SO many more topics to cover! Stay tuned for what’s to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!
2 // Pharmacy Inspection Podcast Episode 2
Show Notes In our second episode we dissect Seth’s experience with attempting to become compliant with USP . We talk about some of the issues he went through as well... as what was done to mitigate the problems. If you’re in the planning stages or about to undertake this project this is an episode you do not want to miss! Special Thanks this week to PharmacyJoe.com for honorable mention on his website and Tony Guerra – @Tony_PharmD (from the Pharmacy Podcast Network) for helping us spread the word of our Podcast! PharmacyJoe.com is a site (and Podcast) created by @PharmacyJoe dedicated to issues within Critical Care Pharmacy, “My mission is to provide you unbiased & practical critical care pharmacy information.” Joe is also a graduate of Albany College of Pharmacy (ACPHS). If you’re a critical care pharmacist, you’ll find his resources and podcasts extremely helpful; you can also get Continuing Education Credit by listening! If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We’re just getting warmed up; there’s SO many more topics to cover! Stay tuned for what’s to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site! Here are the links mentioned during this podcast: Dangers of USP 800 – Executive Summary Dangers of USP 800 – A Cautionary Tale PPP Mag – Facility and Engineering Controls Using USP 800 Guidelines White Paper This is the Graphic that Bryan mentions during our discussion on difference between “laminar” vs “turbulent” airflow.
1 // Episode 1 Pharmacy Inspection Podcast
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