GLPs… Assuring Data Quality

Can you remember back in our good ole’ school days (no, I’m not implying you’re old!) doing those long, drawn out math problems where we had to show every step prior to getting the answer?! The pain, the pain, the pain.

iStock_000005739024_SmallBelieve it or not, it wasn’t just a useless exercise or time-waster . . . there was a reason for it. And a good one. It demonstrated that we understood what we were doing and how we arrived at the answer (versus a quick peak over to our neighbor’s desk and jotting down “their” answer! We all know that doesn’t help us in the long-run, right?!).

Cheating or cutting corners . . . never really gets us anywhere does it?

This reminds me a bit of Good Laboratory Practice regulations (GLP) – created in 1979 to ensure the quality and integrity of nonclinical safety data while supporting the approval of new products. The Code of Federal Regulations spell out GLPs, which can be found here: “21 CFR Part 58

Essentially, the regulations are broken out into various subparts A-K (H and I are reserved), which I briefly highlight below:

  • Subpart A:  Scope, definitions, studies under grants and inspection of a testing facility.
  • Subpart B:  Study personnel, testing facility management, study director, quality assurance unit.
  • Subpart C:  animal care and supply facilities, facilities that handle test and control articles, laboratory operation areas, specimen and data storage facilities.
  • Subpart D:  designing, maintaining and calibrating equipment.
  • Subpart E:  testing facility SOPs, reagents and solutions and animal care.
  • Subpart F:  characterization and handling of test and control articles.
  • Subpart G:  study protocol and conduct of a nonclinical lab study.
  • Subpart H-I:  Reserved.
  • Subpart J:  reporting study results, storage and retrieval of records/data, record retention.
  • Subpart K:  disqualification of testing facilities.

As you can see, they pretty much have everything covered!  As tedious as some of this may seem, GLPs are one of the many ways we assure pharmaceuticals are safe for us to ingest!  Showing and documenting our steps from start to finish may take time and cause some frustration (just like showing every step for your math homework in 9th grade), but it’s all for a good reason.

Following GLPs will provide assurance to regulatory agencies, such as the FDA, on the integrity and quality of the data and reports as well as prevent unnecessary repetition of experiments.

Following GLP regulations will save time and money (and lives!) in the end.

Don’t cut corners. 

Toto's Tips

  • Hire employees (or consultants!) who are fluent in GLP regulations . . . be confident in your data from the start!
  • Not all nonclinical laboratory studies have to be conducted under GLP conditions. Confirm from the start which do and which don’t (as a general rule of thumb, any safety study should be done under GLP conditions, as well as some efficacy).

*Need GLP experts to help assess, implement or maintain your GLP conditions? CALL US!