FDA 483 #10 – Non-Viable Particle Counting
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
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Learn from our informative blog posts that will keep you up-to-date with the latest compliance information; or check out some of our older posts below.
FDA 483 #9 – Bacterial Endotoxin Testing
Learning Objectives Discuss the importance of low levels of endotoxins in parenteral preparations Discuss the limits for endotoxins for various
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
FDA 483 #8 – Using ungraded ingredients
Learning Objectives Discuss the use of USP graded ingredients in pharmaceutical preparations and the importance Explain what prompted the FD&C
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
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Older Blog Posts
Does your Sterile Compounding CPE need improvement?
Compliance with standards is of great importance, not just because of the consequences of non-compliance with regulatory authorities, but truly for the safety of our
Pharmacy Inspection Podcast – Episode 44 – Is my building right for my compounding pharmacy?
483 #6 – 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
WARNING: Hazardous Drug Spill; HOW TO CLEAN UP
Hazardous Cleanup I’ve had a few people contact me about the process for cleaning up a hazardous drug per <800>. It’s slightly different than what
Cleaning up Confusion; correctly cleaning your room
Before we get started… I actually have an entire video series on cleaning and disinfection in the Sterile Compounding Course. I go over a number
483 Friday #5 – 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
FDA to USP: Sterility is top concern with extended BUDs
Tomorrow, September 15, 2020, the USP will be having a call for comments regarding the appeals related to extending Beyond Use Dates in USP Chapter
Save $500K; Hacking USP
USP <800>: Looming Compliance Deadline Less than a year away pharmacies will be expected to comply with USP’s newest standard pertaining to the handling of
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
483 #4 – Investigations & CAPAs
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
What the…what’s Water Activity (Aw)?
There’s been a “new” term that’s been introduced with the revision of USP <795>, Water Activity. There’s an entire 2 page USP Chapter about water
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
483 #3 – Smoke Studies and Media Fills
Learning Objectives Explain the purpose of smoke studies Define the two types of smoke studies that need to be performed Explain the two conditions under
Getting an FDA “Close Out Letter”
An FDA Inspection So you’ve been visited by the FDA and whether you’re a seasoned QA manager at a major pharmaceutical manufacturer or the pharmacist
You received a 483? Don’t Panic…
An FDA Inspection So you’ve been visited by the FDA and whether you’re a seasoned QA manager at a major pharmaceutical manufacturer or the pharmacist
483 #2 – Facilities & Equipment
Learning Objectives Explain the conditions USP Chapter <797> states for surfaces in classified areas Discuss what USP Chapter <797> says about gaps in ceiling tiles
483 #1 – Aseptic Technique 101
Learning Objectives: Discuss proper ways to compound inside the primary engineering control and potential risks of having exposed skin while compounding Explain what must be
LyceumCE is all about Quality Improvement
Hi, my name is Seth DePasquale. I’m a Board Certified in Sterile Compounding Pharmacist. I’ll give you a little bit of background on myself, but
Pharmacy Inspection Podcast – Episode 40 – Don’t make these cleanroom design mistakes!
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
Pharmacy Inspection Podcast – Episode 39 – PAYING TOO MUCH FOR VIABLE SAMPLING!?
Pharmacy Inspection Podcast – Episode 38 – Environmental Sampling Plan
Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site! SUBSCRIBE: You Tube Stitcher Anchor FM
PIP – Episode 37 – Materials of Construction
Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site! SUBSCRIBE: You Tube Stitcher Anchor FM
Pharmacy Inspection Podcast – Episode 36 – Controlling Temperature by putting holes in my cleanroom?
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
Pharmacy Inspection Podcast – 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! SUBSCRIBE: You Tube Stitcher Anchor FM
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
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 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
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
Pharmacy Inspection Podcast – Episode 30 – USP Designated Person
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/7008785/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”] This week Greg Stowell and Jon Pritchett from PCAB (ACHC) speak with us about a new course they’ve released
Pharmacy Inspection Podcast Episode 29 – Process Improvement
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6976989/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”]This week Bryan and I talk about Process Improvement! We give specific examples of how to start out improving a
Pharmacy Inspection Podcast Episode 28 – Bryan and Seth talk Compounding Design Theory
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6901309/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”]This week Bryan and I talk about Compounding Design Theory! This podcast stemmed from a conversation Bryan and I had
Pharmacy Inspection Podcast Episode 27 – RECORDED – USP 797 Proposed Revision with Jon Pritchett
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6870619/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”]Thanks SO so much for everyone that did tune in; I promise next live event I will DEFINITELY RAISE THE
Pharmacy Inspection Podcast 27 – USP 797 Revision Live Discussion with Jon Pritchett
Pharmacy Inspection goes LIVE! – Monday July 30, 2018 at 4:30 pm EST We’ll be doing a live show on July 30, 2018 at 4:30
Pharmacy Inspection Podcast Episode 26 – Vitae Industries (AutoCompounder 3D Printer!)
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6850018/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”]This week we broadcast our interview that we recorded at CCH in June. Bryan was able to sit down with Jeanine
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
Pharmacy Inspection Podcast – Episode 24 – Christine Roussel
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6720757/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”]This week we welcome Christine Roussel, assistant Director of Pharmacy at Doylestown Hospital in Pennsylvania and Program Facilitator for Medisca’s
Pharmacy Inspection Podcast – Episode 23 Greg Stowell
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6616983/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”]This week we welcome Greg Stowell, Education and Consulting Manager for Accreditation University. We discuss how ACHC is helping to
Pharmacy Inspection Podcast – Episode 22 (795 discussed)
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6542454/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”]On April 20th the USP had an online open forum where they discussed the proposed revision of 795. Today on
Pharmacy Inspection Podcast Episode 21 – Lauren Bernick
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6490367/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”]This week we welcome Lauren Bernick, Director of Advertising for the International Journal of Pharmaceutical Compounding. Lauren also runs a
Pharmacy Inspection Podcast Episode 20 – Endotoxin vs Endospores
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6443596/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”]This week Bryan and I discuss the differences between endotoxin and endospores; diving a little deeper into the post from
Pharmacy Inspection Podcast Episode 19 – Donnie Calhoun
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6389871/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”] This week we welcome Donnie Calhoun, Pharmacist, Pharmacy owner and CEO & Executive Director for the American College of
Pharmacy Inspection Podcast Episode 18 – Denise Frank
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6359901/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”] This week we welcome Denise Frank, Pharmacist, Consultant, Educator…within compounding Denise has done a LOT! We met Denise at
Pharmacy Inspection Podcast Episode 17 – Erika Fallon of Fallon Wellness Pharmacy
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6341904/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”] This week we welcome Erika Fallon, Supervising Pharmacist at Fallon Wellness Pharmacy to the podcast. Erika is heavily involved in
Pharmacy Inspection Podcast Episode 16 – Bryan and Seth talk PPE
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6306284/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”]This week Bryan and I discuss proper donning and doffing of Personal Protective Equipment (PPE) – there seems to be
Pharmacy Inspection Podcast Episode 14 – Herschell Hitchcock
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6254993/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”]This week we welcome Herschell Hitchcock, President of EOC1 to the podcast. Herschell is an industrial hygienist by training and has
Pharmacy Inspection Podcast Episode – Brenda Jensen and Jim Hack
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6228930/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”] This week we welcome Brenda Jensen and Jim Hack of Compounding Consultants to the podcast. They both began their
Pharmacy Inspection Podcast Episode 12 – Dr. Loyd Allen Jr.
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6203570/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”]This week we welcome Dr. Loyd Allen Jr. to the podcast. He is the editor-in-chief of the International Journal of
Pharmacy Inspection Podcast Episode 11 – Java Coleman
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6179727/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”] Java Coleman joins us this week. He is a consultant for the pharmaceutical industry through XLN Collaborative Consulting. Java
Pharmacy Inspection Podcast Episode 10 – Rad Dillon
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6154362/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”] This week we talk with Rad Dillon. He is a pharmacist and certified surveyor and consultant for the Accreditation
Pharmacy Inspection Podcast Episode 9 – Joe Cabaliero and Bill Mixon
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6129460/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”] In our 9th episode we speak with Joe Cabaliero and Bill Mixon. Both of these gentlemen have a history
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
Pharmacy Inspection Podcast 7 – Jon Pritchett
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6036619/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”] In our 7th episode we speak with Jon Pritchett, Associate Director of Pharmacy for Accreditation Commission for Health Care. Jon
Pharmacy Inspection Podcast Episode 6 – Bill Fixler
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/6010390/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”] In our sixth episode Pharmacist and rockstar entrepreneur, Bill Fixler talks about his experience in co-owning 3 pharmacies; all
Pharmacy Inspection Podcast Episode 5 Cheri Kraemer
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/5986716/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”] In our fifth episode we welcome Cheri Kraemer, owner and pharmacist in charge of Pharmacy Specialties, Inc. Cheri has
Pharmacy Inspection Podcast Episode 4
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/5942419/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”] In our fourth episode we welcome back Shawn Valandra, owner of SV Environmental Consulting and SVE Filtration. Shawn has
Pharmacy Inspection Podcast Episode 3
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/5918042/height/0/width/0/theme/standard/autonext/no/thumbnail/yes/autoplay/no/preload/no/no_addthis/no/direction/forward/” height=”” width=””] Show Notes In our third episode we welcome Shawn Valandra, owner of SV Environmental Consulting and SVE Filtration. Shawn has experience
Pharmacy Inspection Podcast Episode 2
[podcast src=”https://html5-player.libsyn.com/embed/episode/id/5889240/height/0/width/0/theme/standard/autonext/no/thumbnail/yes/autoplay/no/preload/no/no_addthis/no/direction/forward/” height=”” width=””] Show Notes In our second episode we dissect Seth’s experience with attempting to become compliant with USP <800>. We talk about
Pharmacy Inspection Podcast Episode 1
In Episode 1 of the Pharmacy Inspection Podcast, Bryan Prince and Seth DePasquale introduce themselves and how they entered into the compounding arena. They also
USP 800 Compliance – A Cautionary Tale
The newest guideline, with an enforcement date of July 1, 2018 (real-time countdown to USP 800 is on my home page), has the intention of