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.

Quality Goes Way Beyond a Few Regulations

The quality profession in the pharmaceutical industry is wider than the overseeing regulations from health authorities. The GXPs are truly a starting point, not an ending point which is why we often use that little “c” for “current.”

The GXPs (and the regulations behind them) serve an important purpose. But they are the start of excellence and not the end.

The GXPs are an outline. When we start with these requirements and then fill in the details we build a robust and beautiful engine for quality.

The 5Ps of GXPs: People, Procedure, Product, Premise, and Principles.

This is often why we talk about compliance being the start of quality, and not the end.

GxP New Hire Orientation

Leveraging the company’s new employee orientation program can help both compliance and quality by ensuring that a new hire (or transfer) understands the expectations for employee performance which:

Are covered by the GxP regulations, corporate policies and process/procedure
Are written and readily available to employees
Are mandatory

In a heavily regulated industry, like pharmaceuticals, this is especially important because an individual may not have experienced such regulation in their former position. Even within a regulated organization the level of regulatory experience will change as you move from one area to the next.

The new hire orientation process is not a once-and-done and should be long enough to truly make an impact on the individual’s performance.

This new hire program is seeing to engage new hires more rapidly within the quality culture to ensure that employee’s behavior aligns more rapidly with quality culture.

For example, the new hire orientation should reinforce that a pharmaceutical company is a regulated environment, responsible for products that can directly affect customers’ health and quality of life. Product failure could result in death or sickness. Working for an organization where products help preserve and sustain life comes with the responsibility to know one’s job and perform it correctly at all time.

New hire orientation must present the organization’s cultural imperative for quality – why is it important to fulfill the organization’s purpose or reason for being – and how has this been embedded into the organization’s culture. At heart new hire orientation should answer three questions:

What does quality mean to you personally and how do you exhibit in the organization?
What are the expectations for quality outcomes in the organization and how we judge that they have been met.
How quality is embedded in the culture and daily work of the people in this organization and what represents good role model behaviors.

Content that does not immediately impact the new hire, or only impacts new hires in several departments or units, is better deferred until later training activities.

Topics that would be in that immediate review include:

What does it mean to work in a regulated environment
The role of the quality system
How to access process/procedure and complete training
Good documentation practices and data integrity (high level)
How to engage with regulatory stakeholders and other external partners (high level)

What other material would you cover?