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…
Category: Contamination Control
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 routes of administration Discuss ways…
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 be acceptable? I tried to…
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…
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…
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…
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…
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…
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…