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 Assurance, just one person’s opinion, given the nature of what is being discussed within the chapter, sterile compounding, I would think quality would be literally at the front of everyone’s mind and the same with regard to the order of how the chapter is written.
Nonetheless, there’s a couple things I would like to point out and for anyone reading this to note:
- USP Chapter <797> is a minimum standard. It actually says this literally in the first sentence of the chapter (see below)
- They, your patients, may not thank you for it, but more than likely won’t sue you for at the very least knowing and doing more than the minimum
More than that, you should also note that there’s been a significant expansion within the compounding compendium. If you’ve never heard of this, it’s a compilation that USP sells for about the same price of a discount airline ticket to one of your favorite destinations (but USP doesn’t charge extra for carry on bags). It contains all of the pertinent chapters related to compounding. Now, one other thing that I want to make sure everyone is aware of: USP Chapters numbered greater than 1000 are for “informational” purposes and chapters less than 1000 are “enforceable” (potentially). More on the expansion of the compendium in just a bit.
With that said, let’s go back to the topic of QA/QC. This isn’t necessarily a change within the revision honestly but under section 18 it refers to USP Chapter <1163> (Quality Assurance in Pharmaceutical Compounding). When you look at <1163> there’s a table of “selected compendial testing methods…” that has all of the different types of dosage forms that can potentially be compounded.
Under “injections” there’s many tests that have a “+” which just means “applicable” or “not applicable” (“-“ for not applicable). That doesn’t necessarily mean that these are required, and by no means am I trying to imply this. However, given the type of injection, route, API, etc. it may be a good idea to adhere to performing some of these. For example, how many of us that are preparing sterile medications are testing for osmolarity/osmolality? What about pH? Are you doing a visual inspection of each injectable compound you’re preparing?
If you answered, “yes,” pat yourself on the back. If you answered, “no” to any of these questions, keep reading.
Visual inspection is and has been a requirement within <797>. In fact, there’s even a separate chapter on how to properly do this (USP Chapter <788> Particulate Matter in Injections). If you’re really feeling lively, the FDA even has a guidance on this topic. Actually, within <1163> there happens to be another table that notes each of the chapters where you can find each of these tests and the standards for performing them (NOTE: all of these chapters are enumerated below 1000 – see below).
Qué más?
Within <797> there’s also an expanded section on Sterilization and Depyrogenation (section 10). Strap in, this is where it gets interesting (and as promised here’s the part about the expansion of the compendium also). Within this section two other chapters are mentioned (1228 and 1229 – Depyrogenation and Sterilization). But these are like super chapters (my phrase) because these are technically a “series,” which means there are sub-chapters numbered 1228.1, 1228.2 etc. Again, anything contained within <797>, given the fact that it is below 1000 (797 < 1000), is (can be) enforceable. These other informational chapters that <797> refers to are informational but I highly suggest reading them.
So let me leave you with something to ponder: if <797>, which is enforceable (check your state to see if and when they’ll be enforcing this revision), refers to aspects of quality (e.g., visual inspection – <788> Particulate Matter in Injections, <1163> Quality Assurance in Pharmaceutical Compounding) found in enumerated chapters greater than 1000, would it be a good idea to be compliant with those too?
One more thing, next time you visit ANY restaurant try to find the health department’s inspection and the restaurant’s compliance score. BUT, before you look for it, do me a favor and take out your camera and video your face as you look at the score. When you see a grade less than 100, what’s your reaction? The minimum score that a restaurant can receive before they’re put on super secret double probation is 85. I have to confess, when I see less than 100 my first thought is, “oh dear, why?”
Again, USP Chapter <797> is a minimum standard, I think we can do better than just meet the minimum. If you deserve and expect better than the minimum when you go out to put food in your stomach, shouldn’t everyone have the same expectation with regard to sterile preparations they’re receiving via injection?
