Pharmacy Inspection Podcast – Episode 44 – Is my building right for my compounding pharmacy?
Month: September 2020
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…