GMP Agent In The Field (And At A Desk)

I got hired as a contracted staffer for a remediation project, serving my tour of duty with five other contractors to help with GMP (Good Manufacturing Practices) remediation of a facility.  Two hours from home, so it was easy to get to by car, but still got per diem.   "Temporary Relief" by A. Jarrett is licensed under CC BY-NC-ND 2.0 The client that was in OTC, over-the-counter, medicines.  They mostly did off-patent oral liquids.  One of the name brand OTCs to which the facility was fundamental to was first sold a hundred years ago.   But the company also partnered with a global generic pharmaceutical company on some valuable branded tablets, that had just come more recently off patent, that were packaged at the facility and were more lucrative.  The problem was that the employees did not have a mindset or background in GMP.  For most of the facility's history they manufactured products that the FDA only had marginal contact with...

Pharmaceutical Technology, I believe, used to have a column 'Agent In The Field.'   It was about funny, quirky, or stupid things that had happened in GMP facilities.   Both the company and the reporter were kept anonymous.   The column disappeared, from what I can only guess, were liability/confidentiality issues.   So I decided that I could probably write a column of my own from all the places I've done work.

About me:  I have almost 19 years in the U.S. working in the GMP field.  Mostly validation and QC I started out in a small contract chemistry laboratory doing wet and analytical methods.  These included USB, BP, EP, and JP methods.  Instrumentation included HPLC, GC, AA, TOC, and IC.  Wet methods included USP titanium dioxide assay, arsenic, and lead. Facilities I have worked in include: laboratories, Grade A injectable filling lines, medical device filling lines, transdermal delivery solutions,  vaccines, immuno-oncology product, and a compounding pharmacy.

This story reminded me of an experience calibrating pipettes: Former Theranos Lab Employee Interview   My first job in validation was mostly qualifying CTUs and laboratory equipment.  I had four years of GMP lab experience at this point.  I was used to pre-approved acceptance criteria and protocols and writing deviations for changes to such.  This validation company I was working for mostly did biotech and R&D validation, so non-GMP.  Most clients didn't even see the protocol until it was sent to them for final post-approval. My boss had an ongoing client that mostly had CTUs to qualify.  It was a laboratory doing HIV research.  They needed pipettes calibrated and my boss said we could do it even though I don't think he had any experience doing it.   So my boss bought a balance and some pipette calibration tracking software.  The catch was that since these pipettes were used in a BSL-2, they didn't want to have to decontaminate ...