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: Environmental Monitoring
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…
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…