Getting The Most From Your GMP Supplier Audit

Guest Blogger: Greg Weilersbacher
Founder & President, Eastlake Quality Consulting

All companies outsource. It’s a humbling fact that you simply can’t do it all yourself. This often has to do with resource allocation; your company may allocate dollars to build and sustain some activities in-house while choosing to contract higher-cost operations to qualified suppliers who already have the expertise and equipment. 

You may outsource the manufacturing of tablets, sterile injectable, or topical dosage form, or the GMP release and stability testing of your product. Once the production and testing is complete, the product may need to be stored under controlled temperature and humidity conditions and then distributed to locations around the globe. The Contract Development and Management Organizations (CDMOs) who execute these critical operations are of paramount importance to your company’s success. Choosing the right suppliers will also help to minimize stress-induced headaches throughout your organization. Here are the top five ways to get the most out of a supplier audit.

When Sites, eSystems, and Inspections Meet

Q: Do study site personnel need to be able to answer questions about sponsor-provided computer systems during an inspection?

A: Yes, and there’s a simple thing that sponsors and CROs can do to prepare their sites.

This excerpt was lifted from an online, interactive course entitled “Developing a Part 11 Compliance Plan in Clinical Research.” While the course mainly targeted sponsors and CROs, who have the heaviest regulatory burden in this area, sites also have Part 11 and validation concerns, as demonstrated by this question.

Presenter Lisa Olson, a CSV/Part 11 expert with Polaris Compliance Consultants, briefly described her recommendation, which is both simple and effective. (And since that is total catnip to a compliance blogger, I interviewed her after her presentation to develop the following piece.)

So here it is. Here’s what she said...

FDA Puts Santa on the Naughty List!

        WARNING LETTER

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

December 1, 2018

Mr. Kris Kringle, Owner
Santa’s Workshop, LLC
1225 Santa Clause Way
North Pole, Arctic Circle
 
Dear Mr. Kringle:

The U.S. FDA inspected your manufacturing facility, Santa’s Workshop, LLC at
1225 Santa Claus Way, North Pole Arctic Circle, from April 2 to April 20, 2018.

This warning letter summarizes significant violations of CGMP regulations for finished product. See 21 CFR, parts 210 and 211. During our inspection, our investigators observed specific violations including, but not limited to, the following.

CGMP Violations

1.    Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a) and 211.28).

Many members of your Enterprise Labor Force (ELF) unit lacked sufficient prior experience for designing and assembling (b)(4). At the time of our inspection, no ELF members had received training on CGMPs, and most were unaware of their responsibilities in the areas of cleanliness and proper attire. Hands and faces were often coated with chocolate, and bells on hats and shoes prevented protective apparel from attaining a proper fit. More generally, factory staff demonstrated an undisciplined, almost gleeful disregard for quality procedures. On three separate occasions, at critical stages of the manufacturing process, floor workers erupted into spontaneous song and dance.

The One-Hour Study Site Audit

In an effort to tease out the priorities of a clinical study site audit, I asked six of our most experienced GCP auditors the following question:

If you only had one hour to conduct a study site audit,
what would you look at?
[Obligatory warnings:  Do not try this at home. This is just a simulation. Caveat lectorem. Dinosaurs in the mirror are bigger than they appear. Et cetera.]

Of course it’s not possible to conduct any kind of meaningful audit in so short a time, but it’s an interesting thought exercise because it gets to the heart of study site risk.

What Suprises GCP Auditors?

Last month, I scheduled one-on-one discussions with our most experienced GCP auditors to ask each of them the same question: What surprises you most about the audits you conduct?

I guess you could say that I was the one who was surprised. I’m not sure exactly what I was expecting to hear, but I thought my teammates were going to talk about things that were new. Instead, I heard a lot more about things that have been around for a long time. To a person, my colleagues said they were surprised to be observing some of the same audit findings they were observing 30 years ago...which *is* surprising when you consider most of them were mere children at the time. ;-)  It seems we have some stubbornly persistent quality and compliance issues in the biopharma industry that decades of neither experience nor technology have seemed to remedy. And the problems are not just persistent; they’re interrelated.

Hackin' the GDPR

Trying to comply with the GDPR got you down?
Maybe our parody will cheer you up.

(Sung to the tune of Lennon-McCartney's "Back in the U.S.S.R.")

eSource Terminology Untangled

True or False:

(1) eSource in clinical trials means eliminating the possibility for transcription errors.

(2) Data collected in Electronic Data Capture (EDC) systems is eSource.

Strictly speaking, both statements are false. If that surprises you, it’s probably because many casual uses of the term “eSource” actually differ from the formal definition laid out by FDA. If the participants in any discussion share the same interpretation of “eSource”, or if it’s clear from context how “eSource” is being used, then no harm, no foul. (Contemporary translation: “Meh.”) BUT…and you know where we’re going with this…when a term can be interpreted in multiple ways, there’s always a possibility for miscommunication and cross talk.