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…
Category: Sterile Compounding
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…
Pharmacy Inspection Podcast – Episode 40 – Don’t make these cleanroom design mistakes!
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Pharmacy Inspection Podcast – Episode 38 – Environmental Sampling Plan
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PIP – Episode 37 – Materials of Construction
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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…
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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…