GxP are the quality standards and regulations for a specific field or activity. GxP revolves around two main regulatory pillars: accountability and traceability. Accountability refers to the ability to demonstrate what each person has contributed to a product or project and when they contributed it. Traceability means that there needs to be a way to reconstruct the entire history of a product or project’s creation. To be compliant, organizations need to document and log every action made by every employee in the development or production of a product or project.

GxP exists to protect consumers like you and me. The guidelines are created and enforced by national or international regulatory agencies, like the United States’ Food and Drug Administration (FDA) or the global International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to ensure that products, research, and projects are done safely and that the end products are safe to use.

The ‘x’ stands for the particular field, whether that’s manufacturing (GMP), distribution (GDP), laboratory (GLP), and so on. They aim to ensure that businesses working in regulated industries manufacture products that are safe and fit for use, meeting strict quality standards throughout the entire process of production. The guidelines are generally similar from country to country, and each country has its own regulator. But for many manufacturers, the FDA’s requirements are king – the US market is the world’s biggest, and so the most profitable.

The 5 Ps of GxP

GxP is no different to any other quality benchmark in that it’s complex to interpret and difficult to put into practice.

The guidelines themselves are the minimum requirements that an organization needs to meet to ensure that the quality of their goods or services is consistently high. Generally, the guidelines cover products or projects that could put peoples’ safety at risk. That’s why GxP compliance is essential for food, pharmaceutical, medical device, and life sciences organizations as well as for any other companies who work within regulated industries.