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Examples in Process-Mapping -- Getting Started (Pharm/Biotech Examples)
Last months newsletter discussed getting started mapping your process and discussed some general examples.

This month, because so many of you are implementing Stability, Drug Metabolism, and multi-level testing (e.g., Dissolution and Content Uniformity), I wanted to provide a few examples of those items. I should also point out that, when I talk about Content Uniformity I’m discussing Uniformity of Dosage Units, not the other Content Uniformity testing that goes on for the blender.

Example 1: Drug Stability Studies
Quite a few of the LIMS come with Drug Stability modules these days. As you’re considering the functions in this package, you’ll want to create the fewest number of templates possible (templates being the master template that you use over and over again).

Some examples of the questions you might ask yourself concerning this process-mapping example:
  • Is our testing the same for every time point and condition across our studies?
  • If our testing is the same for every time point and condition across a study, are there any holes in the matrix? That is to say, do we do those tests for every time point and condition across the study?
  • What types of things happen to our studies? Do we get rid of time points? Do we temporarily put a study on hold? What happens within LIMS when we do these things in real life?
As I mentioned last month, you already have the answers to a number of these questions. Ask them anyway. I’ll reiterate my tip from last month: it is good to ask obvious questions because it ensures that you answer them, and it can help draw answers from other people.
Example 2: Drug Metabolism and Pharmacokinetics via Stability
Ten years ago, a number of the big LIMS vendors had or were trying to create these packages. Then, it was just the specialty vendors that were carrying them. Now, it appears that at least one of the "big" brands is getting back into this market. Regardless, some of you will try to put this capability into your LIMS that do not have this type of functionality. If your LIMS vendor has only a Stability module, the first thought is that a study is a study as far as LIMS is concerned. You’ll see that’s not true when you start asking yourself some questions.

Some examples of questions you might ask yourself concerning this process-mapping example:
  • How does the Stability study functionality map to this?
  • Are we planning to pre-screen our subjects and put that data into LIMS? If so, how do we map that to our study?

Example # 3: Dissolution, Content Uniformity, and Other Multi-Level Testing
These tests should be grouped together when mapping them to the LIMS because the functionality they need is the same, even though the methods are different. From a LIMS standpoint, the solution for one is usually the solution for the rest, except for the actual evaluation methods, of course.

Some examples of questions you might ask yourself about Dissolution:
  • What type(s) of Dissolution are we doing? What type(s) of Dissolution are offered within the LIMS?
  • Are we doing merely USP 711 (single point) and USP 724 (rates), or are we doing others as well, such as drug-specific methods?
  • Are we really following the USP? Are we also trying to follow the BP and EP rules as well?
  • Do we want complete control over the staging?
  • What are the exceptions and what happens in LIMS (e.g., the chemist might forget to put one of the tablets in)?

Imagine for Content Uniformity that you’ll ask similar questions. For example, if you’re doing USP 905 Content Uniformity, is that both Type A and Type B? What about the label claim?

If you’re doing other types of multi-level testing, you’ll have similar questions and should go into more detail. I’m not currently aware of a LIMS that handles these other methods specifically, so those of you doing this will probably need to spend extra time considering what strategy will work best for you within LIMS.

Once again, I think you get the idea. I hope these examples help get you thinking about the questions to ask to start this task.

 
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