Records R'nt Us
It was, our GMP Agent-in-Place recalls, a typical, small, clinical-type facility... managed in the typical, informal way.
High employee turnover and lax financial record-keeping finally caught the attention of off-site management, which ordered
a financial audit. "The audit did turn up financial irregularities," says the Agent, "and it raised serious questions about
the site's GMP record-keeping, so we started reviewing those, too. The icing on the cake was a facility cleaning record, signed
by the same employee on 30 consecutive days... all with the same pen, and including 15 days when the pay records indicated
that he'd been on vacation. So either the employee was cooking the cleaning records, which was illegal, or he had worked more
than 21 days in a row without a day off and falsified pay records, which were both illegal.
"Management called in the FDA, who sent an investigator to 'help' with our internal review. So we had two auditors and an
FDA inspector in the same small facility simultaneously, poring over records. At the end of each day, we would get together,
share our audit findings with each other, and shake our heads.
"In the end," our Agent-In-Place notes, "we took marketplace action for the product, fired all the staff, and closed the site.
And we didn't lose any time before auditing all of the other similar sites in our network for similar deficiencies. Thank
goodness, this one was unique. FDA issued a warning letter for lousy records, of course, but that was the end of it."
I 'speckt so
The maker of an injectable drug product used a dry powdered raw material, purchased in bulk and added to multiple batches.
Midway through the drum, process operators adding the raw material to the batch noticed small, black specks in the blend,
says the GMP Agent-in-Place on the scene. The manufacturer immediately quarantined the earlier finished batches and initiated
"After an extensive study, including examination of hundreds of raw-material drums and hundreds of hours of analytical work,
the investigators determined that the particles were flecks of carbon," the Agent says. "Since they weren't soluble in the
water we used as a solvent in the final product, normal filtration removed them, so the finished product was not adulterated.
"Of course, every batch of raw materials contains some impurities, though most are not visible. Our carbon specks accounted
for less than 10 parts per million of raw material: there would be only a few particles in any 5 kg sample...very rare and
very hard to see.
"Eventually, we determined that the particles were actually the raw material itself, carbonized during the extraction process.
Since they posed no threat, our solution was to work with the vendor to establish an appropriate specification for the raw
material, one that included low levels of 'discolored impurities.'"
It made me want to cry
"It was a nightmare," reports a GMP Agent-in-Place whose company made a liquid ophthalmic product. "Suddenly our customers
began complaining about pain and burning of the eyes after using our product. We made 200,000 containers in a batch, and all
the recent batches had been affected."
"Right away, we set up a crash program to investigate, testing the product exhaustively and matrixing all ingredient batches
"Someone suggested that the plastic container might be responsible, and we traced down all of the components of the container,
closures, and seals.
"We followed the trail to the company that molded the plastic bottles, and from there to the company that supplied the resin
to the bottle-maker. It turned out that the resin supplier had changed the colorant they used, without telling anybody down
the line. And the colorant was leaching out of the container and irritating the customers' eyes.