"I'd Like to Help Us Get Through An FDA Audit, But It's Tax Season."

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.  

I was brought in to help with the purified water system.  It had not been validated since it was installed at least ten years prior.

"Measuring water purity with TDS meter"by yourbestdigs is licensed under CC BY 2.0

The company's large global partner had sent an internal auditor from overseas and audited their water system.  I was tasked with addressing these problems including writing memos stating why or why not audit findings needed to have further action.  Most of the items on the internal audit were suspected dead legs in the system.  At this point I had experience in purified water systems from simple deionized, resin-bed systems, up to heated-loop WFI (Water For Injection) systems.  I had also had experience with remediation based upon FDA audits, including addressing an FDA finding on a warning letter for an injectable filling line.

Their water system was their biggest ingredient, but had problems.  I did brief checks of P&IDs (process and instrumentation diagrams), seeing as how that sets a great base for a new system in commissioning.  A good amount of tags were wrong or missing.  They also used the same tag IDs between different rooms.  This may have been okay if it all the systems were discrete to each room, but this was one purified water system running through the entire facility.  And this is after they said they had paid an intern from an engineering firm to give them red-lined and corrected P&IDs. 

The manufacturing facility had taken out their carbon filters on the purified water system because they were believed to not be needed anymore, but now wanted to put them back in because the city had switched from chlorine to chloramine and they had high microbe growth, so they believed that adding the carbon filters back in would reduce microbes in the system from their experience before.  

Furthermore, the company hired project managers from an engineering firm that had no background in GMP projects.  Conversely, anyone who had any GMP experience was not given any authority or final say.  The head of quality and head of engineering also had no previous GMP experience.  The new directly hired engineer for the company that I most closely worked with had no previous GMP experience.

The purified water system was ozonated with UV lights for ozone removal before adding purified water to the product mixing tanks.  UV light degrades ozone quickly.  The ozone was bubbled in through the holding tanks.  They had made changes to the purified water lines and automated de-ozonation setup, but hadn't done any documented testing to confirm that ozone was removed from the water before adding to product.  

Ozone

They had no yearly performance evaluation or any other documentation for the purified water system that they could readily hand to an auditor or client.  They actually did periodic testing, but all the results were in laboratory notebooks.  They had in an in-line TOC (Total Organic Carbon) unit, but since this was on the plant floor it was more up to the utilities department to document results, including alarms, in a composition notebook in the water mechanical room when they thought they should.

I asked the laboratory manager if he had any of the data in compiled format, i.e Excel spreadsheets.  Nope.  I prompted the lab manager that he or his subordinates should at least be compiling the data.  The re-qualification (performance qualification) of the water sytsem kept getting put off and put off.  The main reason being that they were remodeling a portion of the facility and adding another purified water loop, so they wanted to wait until that was done.  Executing my due diligence, I chatted with the purified water loop construction company to make my expectations clear on commissioning document deliverables that I would want: materials of construction certificates (MOC), any welding cert's, pressure testing results, and P&IDs.  The construction company foreman said "Yeah, we always have that, but they never want it."

They had written a commissioning SOP, but there was no real meat to it.  I put together a bunch of forms for them that they could use to execute commissioning on systems, facilities, and equipment based upon a system I used and liked.  

Since they were putting the purified water loop into service in the remodeled/new area, they wanted a performance qualification (PQ) written for it.  I instituted the commissioning principles and forms into it to leverage that data without causing undue deviations/exceptions.  They flat out said they were not going to do commissioning, even though they had an SOP for it.  Someone else, who had no GMP experience, then secretly took over the project.

I then focused on doing something that would at least help them get through an audit.  Something for QA/QC to show an auditor about their water system that would prove it was in a state of control.  I talked with Quality Assurance (QA) and urged them to get QC (the laboratory) to organize the data from hard-bound laboratory notebooks to put into a spreadsheet report for trending, even if it wasn't Part 11 compliant.  This is after being on-site to qualify the purified water system after a year.  A draft of the performance qualification had been ready for six months at least.

One day, I'm trying to track down the laboratory manager.  His employees tell me he is out on vacation for a month.  "Yeah?"  They say: "He takes off a month off every year to work at H&R Block preparing taxes because he likes it so much."  Apparently the impending threat of an audit, internal, external, FDA, regulatory agency foreign or domestic, like a sack heavy bricks, did not dampen the morale of this company's lab's QC manager or the ability of him to take a vacation to work a second job as a hobby!