GxP is shorthand for “good practices”. These practices are the quality control guidelines organizations follow to make sure they are putting out safe and effective products.
The “x” in GxP is a placeholder for whichever area of the organization the good practices are used. For example, GMP is good manufacturing practices while GLP refers to good laboratory practices. You’ll also sometimes see the letter “c” attached to good practice (e.g. cGMP), which just means the current version of these good practices.
GxP is an important part of heavily regulated industries. In these sectors, such as the pharmaceutical, hospital/healthcare, medical device manufacturing, aerospace, and food and beverage industries, creating safe, quality products is crucial to keeping the public safe and healthy.
To explain more about GxP, how it is used, why it is critical for many industries, and how it affects everyone’s daily lives, here is an essential primer on GxP.
What is GxP?
Good practices are vital in industries and departments within organizations where the public will interact with the product a company or specific department produces. This means the accounting department doesn’t have a need for GxP in this sense of the term, but the production department responsible for manufacturing the product a company sells certainly does.
There is no single definition for GxP. It is different in every industry and in each segment of those industries. The guidelines for GMP will be very different from those for GDP (distribution).
In addition to ensuring the quality and integrity of the products within these areas, there are also several overarching pillars that all GxP share. These are:
One standard of GxP is to create the ability to trace the journey of a material or product through its entire process. This means qualifying not only the process as a whole but each step and piece of equipment involved in the process to make sure everything is doing its job.
Traceability also involves recording as much data as possible. If something goes wrong or isn’t working, you want to have as much information as possible about the batch composition, the environmental conditions, and other significant factors. This is what gives organizations the ability to trace for GxP.
Accountability is similar to traceability in many ways but it applies more to the people involved in the process as opposed to the equipment. This pillar of GxP makes sure everyone involved in the specific process is qualified and properly trained. This is also where records are kept about who was involved in the process and when so that the person or people involved can be identified if something goes wrong. This information will make it easier to find out what happened, how it can best be remedied and how to prevent the occurrence from happening in the future.
The two pillars of traceability and accountability above involve capturing, recording, and analyzing lots of data when done right. For that reason, data integrity is the third pillar of GxP. This means it is critical to regularly gather the full data and to verify its accuracy.
These days, it is also incredibly important to safeguard that data. In 2020, the number of cyberattacks skyrocketed and they show no sign of slowing down in 2021 and beyond. Protecting data, especially if it is proprietary, sensitive, financial, or personally identifiable needs to be a top priority in GxP.
What regulated industries use GxP?
Dickson’s guide to GxP notes that it is a major quality assurance process across many industries. These industries all have in common that their products are used by the public and, if the product is unsafe or ineffective, that condition generally won’t be visible to the average person. That is why GxP and general quality and safety are so important. Here are a few examples of industries where GxP is widely used to great effect.
If pharmaceutical drugs go bad for any reason and either become unsafe or lose their effectiveness, it can be very bad for the people using them. That is why, in this industry, GxP is used at every level.
GLP is used in laboratories during research and development to make sure conditions are right to get accurate results. GMP is used while creating products and GDP is used to make sure these products still work on the way to the final destination. GxP was on full display in 2020 when the pharmaceutical industry successfully created safe and effective COVID-19 vaccines in record time.
There are more than 250 foodborne illnesses. These make 48 million people sick in the U.S. alone every year, send 128,000 to the hospital, and kill around 3,000 people. One way GxP is helping to reduce or even eliminate this is with proper food handling training.
If the people who handle food know regulations and standards related to food temperatures, cross-contamination, and other factors, they will be better able to get food safely from farm to table, which is good GxP.
This is another industry throughout which GxP runs. Here,regulations and standards go not just throughout the manufacturing process, but through the whole supply chain. Each part that goes into an airplane needs to be produced with GxP in mind. When those parts are assembled, GxP is there as well.
In this industry, GxP standards are often paired with efficiency and cost-reduction programs that help keep air travel not only safe but affordable for ordinary people.
These are just a few examples of how GxP is implemented in heavily regulated industries and how, while you may never see or experience the GxP standards first-hand, they do affect your life in many invisible ways that you never consider.
GxP is ever-changing and evolving to include the best and most relevant information to help organizations produce high quality products. When done right, GxP should be regularly updated and wise administrators will give frequent training and review to the people who use these practices in their work. Ultimately, those who do this will have better safety records than those who don’t and will save money in the long run..