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 grea...
Pharmacy Inspection Podcast
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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.
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 route...
Pharmacy Inspection Podcast – Episode 48 – Can we share 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...
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 act of...
Pharmacy Inspection Podcast – Episode 46 – HEPA Filtered Exhaust
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?
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 Frid...
Pharmacy Inspection Podcast – Episode 44 – Is my building right for my compounding pharmacy?
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 incredib...
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 ...
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 typ...
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...