The GxPs – a brief definition

Jargon is something we should work hard to avoid, and yet there is an awful lot of it we find difficult to let go. Right at the top is the GxPs.

GxP is a general abbreviation for the “good practice” quality guidelines and regulations. The “x” stands for the various fields, including the pharmaceutical and food industries, for example good manufacutiring practice, or GMP.

There are a lot of GxPs, though we tend to focus on 5(ish), depending on where you are.

We tend to argue a lot about them. Even to the GxP vs GXP. Or GPvP vs GVP. Or GdocP or GDP (so damn confusing, there is another GDP – Good Distribution Practices). Or if Good Storage Practice is its own body or part of the GMPs and GDPs. And…and…and.. The arguing can be fun.

The Five big ones in pharma and medical devices are GLP, GCP, GMP, GDP and GPvP. Some of the others like GACP are pretty intesting in their application.

Some like GDocP and GAMP are more specific threads that go across the GxPs.

By nature the GxPs are tied to the phase of the pharmaceutical pipeline.

The GxPs are all about ensuring compliance and are informed from a wide range of sources, starting with law and regulations.

Being in the age of globalization, there are many many sources to draw from.

This can also draw from beyond the health authorities (for example in the US USDA for GACP or the DEA for parts of the GDPs).

At the end of the day, GxPs answer to five important criteria.

Resilience

In the current world scenario, which is marked by high volatility, uncertainty, complexity, and ambiguity (VUCA), threats are increasingly unforeseen. As organizations, we are striving for this concept of Resilience.

Resilience is one of those hot words, and like many hot business terms it can mean a few different things depending on who is using it, and that can lead to confusion. I tend to see the following uses, which are similar in theme.

Where used	Meaning
Physics	The property of a material to absorb energy when deformed and not fracture nor break; in other words, the material’s elasticity.
Ecology	The capacity of an ecosystem to absorb and respond to disturbances without permanent damage to the relationships between species.
Psychology	An individual’s coping mechanisms and strategies.
Organizational and Management studies	The ability to maintain an acceptable level of service in the face of periodic or catastrophic systemic and singular faults and disruptions (e.g. natural disasters, cyber or terrorist attacks, supply chain disturbances).

For our purposes, resilience can be viewed as the ability of an organization to maintain quality over time, in the face of faults and disruptions. Given we live in a time of disruption, resilience is obviously of great interest to us.

In my post “Principles behind a good system” I lay out eight principles for good system development. Resilience is not a principle, it is an outcome. It is through applying our principles we gain resilience. However, like any outcome we need to design for it deliberately.

Principles behind a good system

We gain resilience in the organization through levers that can be lumped together as operational and organizational.

The attributes that give resilience are the same that we build as part of our quality culture:

The ability to anticipate problems before they build-up (includes risk management)
Diversified structural flexibility to respond to both adverse and beneficial changes
Broken down silos and glass ceilings to allow risk information to flow freely and prevent ‘risk blindness’
Rapid response capabilities to avoid incidents escalating into crises
Learn from previous mistakes from themselves and others making the necessary changes

On the operational side, we have processes to drive risk management, business continuity, and issue management. A set of activities that we engage in.

Like many activities they key is to think of these as holistic endeavors proactively building resiliency into the organizaiton.

ASQ Poster Session

In 2023 I start my leadership cycle through the Food, Drug and Cosmetic division, starting as chair-elect. This means time to do some content creation! Here’s the first thing I have planned.

The Food, Drug, and Cosmetic Division will be hosting a poster share on February 28th from 3-5 pm in Boston, with a cocktail hour afterwards (5-6). The event is being sponsored by Veeva Systems and will be free (big shout out to Veeva!)

We are looking for individuals and companies to share a poster on the theme of “What are you proud of in your eQMS? What about your implementation or continued use stands out and that you want to share?”

If interested in presenting a poster, please complete this form.

We ask that all posters be completed by the 22nd of February so we can get them printed.

We will record the poster presentation and make them available through my.ASQ after the event. Poster presenters must sign a standard ASQ waiver (we will make it available before the event).

An event sign-up will come out in January.

The event is open to all. While I’m thinking the focus will be heavily focused to FD&C and medical device members, other quality professionals will get value.

So please present a poster! I am very excited about this sort of sharing of ideas. I want to keep experimenting with alternative ways to share information and network, and I think the old poster session is something that has renewed utility in this day-and-age. Sort of a speed conference. Easier to create a poster and can be a compact event.

EMA Publishes 2021 GCP Compliance Report

The EMA has published the Annual Report of the Good Clinical Practice (GCP) Inspectors Working Group (IWG) 2021.

Beyond wishing for an 11 month cycle of writing and approval on my annual reports, there is some valuable information there.

In 2021, three CHMP GCP inspections were conducted entirely remotely, and three inspections were conducted in a hybrid setting. A total of 286 deficiencies, comprising 24 critical, 152 major and 110 minor findings were recorded for the 27 CHMP requested inspections conducted in 2021. This represents an average of 10-11 findings per site inspected. The three top categories were: “General”, “Trial Management” and “Computer System”. An increase in findings related to computer systems (e. g. Audit Trail and Authorized Access, Computer Validation, Physical Security System and Backup) is noted compared to the last reports.

More information is available at EMA´s Good Clinical Practice Inspectors Working Group website.

Under organisation and personel we see “Delegation of tasks to inappropriate team members.” This reinforces the needs for strong cv and job descriptions, and linking to both hiring and personnel qualification.

The computer systems observations are the greatest hits of data integrity, and should be a wakeup call to any company that treats GCP and GMP computer systems differently.

Let the 2022 annual GCP training development begin. And make sure you get that training done on time!

Sunscreen is a drug

Folks often forget that in the United States the active ingredient in sun screen is a drug and needs to meet appropriate quality system requirements. This Warning Letter to Kari Gran, Inc is a case in point.

The whole warning letter is a result of a company not realizing (or thinking they can get away with not having) the need for GMP compliance.

I’m not sure I would draw broader trends around data integrity or anything else from it.