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The “new” 797 Competency Testing in Aseptic Manipulation assessment? – MEDIA FILLS Explained…Part 2 of 4
This is the second in a series of posts that I’m writing to fully explain the “new” Competency Testing in Aseptic Manipulation assessment in the latest revision to USP <797>. In this article we’re going to talk about media fills. This always seems to be a topic that people scratch
The “new” 797 Competency Testing in Aseptic Manipulation assessment? – EVERYTHING Explained…Part 1 of 4
I have had many people ask about USP Chapter <797>’s “new” Competency Testing in Aseptic Manipulation. Why do I put “new” in quotes? The truth is, this actually isn’t necessarily new. It is the way this should have been performed all along. USP has done a much better job of
I’ve received a 483 Form; how should I respond?
When the U.S. Food and Drug Administration (FDA) conducts an inspection of a pharmaceutical facility, they might issue a Form 483 if they observe any conditions that, in their judgment, may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related laws. Receiving a Form 483 can be
Parts of USP 797 revision NO ONE seems to be talking about…ESTÁS LISTO?
I’m not sure why this is but USP’s Chapter <797> section on Quality Assurance and Quality Control (QA/QC) has always been almost like an afterthought. It’s at the very end of the chapter and doesn’t take up much space. The revision coming in November follows suit with previous iterations. Quality
Cleaning up Confusion; correctly cleaning your room
Confusion over cleaning I have to admit I’ve also been confused about the cleaning protocols and procedures for a cleanroom environment. The basic techniques, I’ve got that down (but I’ll talk about that too); there’s a lot of products to clean with and rotating your cleaning agents. It’s confusing, to
When your life depends on it…
You’re in the middle of nowhere, lost. Your phone is dead, you are out of gas, no food or water on a desolate road, and you haven’t seen another person in hours. You think, chances are, I’m probably not going to for several more. What do you do? Well, if
Did you just call me an asymptote? What the…wait, what’s an asymptote?
Continuous improvement, attaining the highest quality in our work; it never stops. It isn’t meant to! It isn’t a coincidence that “continuous” is the first attention-getting word in the term. It’s an asymptote, intentionally. You are never going to touch that X or Y axis. You’re not meant to achieve all of your goals and dreams. Even the most fortunate don’t get “W’s” every time they set out to do something. Does that mean we should stop launching satellites above and not have high-speed internet no matter where we are (thanks, Elon 😁)? NO!!
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I’ve received a 483 Form; how should I respond?
Parts of USP 797 revision NO ONE seems to be talking about…ESTÁS LISTO?
Cleaning up Confusion; correctly cleaning your room
When your life depends on it…
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