For those unfamiliar with the acronym, GxP stands for “good practices,” with the “x” representing a variety of subcategories of “good practices”—for example, “good manufacturing practices” becomes GMP. “Good laboratory practices” becomes GLP. “Good clinical practices” becomes GCP.
“Good practices” may sound like a subjective term, but they really aren’t open to interpretation. Various watchdog agencies formulate, publish, and maintain GxP standards that organizations in the relevant industry must follow.
For example, the Society of Automotive Engineers (SAE) maintains AS9100, a set of controls for the aerospace industry adapted from ISO 9001, a standard created by the International Organization for Standardization (ISO). Sometimes the standards are developed by the very organizations that regulate those industries, like the US Food and Drug Administration (FDA).
In a way, “good” is a misnomer, because “good practices” aren’t just suggestions—especially in heavily-regulated industries like pharmaceuticals, medical devices, aerospace, and food production. A better term would be “mandatory,” since these industries can’t afford to do business without attention and adherence to “good practices.”
1. Regulatory Compliance
GxP is nobody’s favorite aspect of running a business or organization. But as Dickson notes in their GxP guide, GxP is a major part of maintaining regulatory compliance in many industries.
The organizations that have to concern themselves most directly with GxP usually do so at the behest of regulatory watchdog groups. They face stiff regulatory burdens to remain in operation. Examples of regulatory authorities include:
- The US Food and Drug Administration (FDA). The FDA provides regulatory oversight for the pharmaceutical and medical device industries, among others, which operate in the US.
- The European Medicines Agency (EMA). The EMA provides regulatory oversight for the pharmaceutical and medical device industries, among others, which operate in Europe.
- The US Department of Agriculture (USDA). This cabinet-level bureau of the US government provides oversight to food-production and agricultural organizations.
The process of confirming that an organization follows the required GxP is called “validation.” It must usually be performed once a year, and some industries may be subject to randomized regulatory audits. Organizations may perform their validation with the help of an in-house team or with third-party validation specialists.
What happens if an organization in one of these industries fails to validate the required GxP? The consequences can be ruinous—hefty fines, even orders to shut down operations. If nothing else, GxP represents a hurdle that organizations must clear to keep the doors open.
2. Product Quality
Ultimately, all this regulation is geared around the fact that public health and public safety depend on the quality of these industries’ output. The regulations are not there just to tyrannize businesses. Regulators enforce GxP to ensure that these organizations produce high-quality products.
GxP are meant not only to ensure product quality, but also product consistency. If one out of every ten products is faulty, or one out of every 100, public safety would be compromised, consuming those products a game of Russian Roulette. GxP is one of several controls that ensure that the quality of any one product in a warehouse is representative of the quality of the entire warehouse.
3. Data Integrity
Organizations depend on data for validation of GxP as well as for other functions. In order to reveal anything of substance and consequence, that data must have integrity. Part of any regulated organization’s GxP will include standards for the handling of critical data to maintain its integrity.
To understand what is meant by “data integrity,” let’s look at the ALCOA standard, as maintained by the FDA. To have integrity, data must be:
- Attributable. The data must be able to be traced to the source of its recording. Whether it was recorded by a machine or a person, that source must be identified to be held accountable.
- Legible. The data must be interpretable by human eyes and minds—or by other machines that can render the data legible.
- Contemporaneous. The data must have been recorded at the most relevant time possible—preferably, at the time the reading was taken. Waiting hours or days to record the data degrades its integrity.
- Original. The data must be in its original recording form, although digital data may be considered original if it is duplicated or copy/pasted. However, a handwritten copy of a handwritten original is not an original, since human error could undermine the integrity of the data.
- Accurate. The data must correctly represent the conditions it recorded, thanks to the proper use of well-calibrated tools.
4. Organizational Accountability
A key component of GxP is organizational accountability—systems that enable problems to be traced back to the responsible party.
Businesses typically prefer to insulate themselves from accountability as a component of risk management, but to maintain public safety within regulated organizations, the organizations need to understand that they can and will be held accountable for their output. GxP help put those systems of accountability in place.
5. Public Trust
One thing that heavily-regulated industries have in common is that they depend on public trust. Consider that the products made by the pharmaceutical and food industries are actually consumed by people—their health depends on them. The same is true of medical devices like pacemakers and glucose monitors. In the case of the aerospace industry, consumers must board aircraft with confidence that it won’t malfunction and crash.
In a way, public willingness to accept the output of these industries is a testament to their faith in regulators, the organizations themselves, and the GxP organizations adopt to achieve consistency of output. Consider the widespread public acceptance of the COVID-19 vaccines produced by top pharmaceutical companies, despite the speed with which they were developed and tested. Or the lack of mass abandonment of commercial air flight and Boeing jets in general when the faulty Boeing 737-MAX led to a series of fatal crashes.
Ultimately, the public isn’t going to personally test every food product, every drug, every aircraft they encounter. Industry adherence to GxP is a key source of public confidence in the quality of these products—confidence that is critical not only for the industries themselves, but for the consumers who depend on their output and upon whom the industries depend for their survival.
Conclusion
When adopting practices that may seem burdensome, it helps to understand why you are doing it. In the case of GxP, its importance for regulatory compliance, product quality, data integrity, organizational accountability, and public trust make it clear why GxP must be a crucial process for every organization in a heavily-regulated industry.
