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: 483s
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…
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…
You received a 483? Don’t Panic…
An FDA Inspection So you’ve been visited by the FDA and whether you’re a seasoned QA manager at a major pharmaceutical manufacturer or the pharmacist…
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…