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: Podcast
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…
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…
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…
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…
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…