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…
Month: October 2020
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…
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 1938 to be…
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…