Every industry has its own jargon, often punctuated by an alphabet soup of acronyms. The last thing you need when learning the ropes in a new industry is an overarching extra alphabet soup that applies to multiple industries—especially one that relates to regulatory compliance.
It gets even worse when one of the letters in that alphabet soup is “x.” Anyone who remembers algebra class knows that “x” is a variable—it could be a stand-in for many things.
GxP is all of those things—and yet employees and entrepreneurs entering into highly regulated fields can’t ignore it. Let’s rip the band-aid off and take a 10,000-foot view (in a compliant aircraft built with great GxP).
What is GxP? What industries does it apply to, and why is it so important?
According to Dickson’s GxP guide, GxP involves a series of guidelines and standards regulated organizations should use to maintain compliance.
The “G” and “P” actually stand for “good practices.” The “x” in between is a placeholder for industry- or activity-specific “good practices.” Examples include:
- GCP — Good Clinical Practices
- GMP — Good Medical Practices
- GLP — Good Laboratory Practices
Sometimes, you will see “c” appended to the beginning of the “good practices” abbreviation to indicate current good practices—for example, cGMP to indicate “current good manufacturing practices.”
Numerous industries depend on GxP to assure consumers of the quality of their products, as well as to comply with regulations. Examples include:
- Pharmaceutical. The pharmaceutical industry must abide by good clinical practices (GCP), good laboratory practices (GMP), and good manufacturing practices (GMP), as well as good storage and distribution practices. In the US, pharmaceutical GxP is validated by the Food and Drug Administration (FDA). In Europe, this regulatory responsibility falls to the European Medicines Agency (EMA).
- Medical Devices. Similar to the pharmaceutical industry, the medical device industry is held to high standards of GCP, GMP, and GLP. Again, agencies like the FDA and the EMA enforce regulations and review validation of compliance from medical device companies.
- Aerospace. Good manufacturing practices (GMP) are critical to the aerospace industry to ensure that aircraft are safe and airworthy. The AS9100 standard is the gold standard for aerospace GxP, a variation on ISO 9001 developed and maintained by the Society of Automotive Engineers (SAE).
- Food and Agriculture. Good practices in storage, handling, and manufacturing of food products make a big difference in the safety of various food and agricultural products. GxP for US agriculture are largely found in the Food Safety Modernization Act (FSMA) of 2011 and enforced by the US Department of Agriculture (USDA).
The most notable reason that GxP is important is that it ensures a certain standard of quality in industries where quality assurance matters the most—for example, when people will be consuming manufactured or perishable products. Or when they adopt the usage of a medical device that may save their life or potentially harm them. Or when they step on board an aircraft, the malfunction of which could put their life in danger.
How do GxP accomplish this level of quality assurance, especially across so many sensitive and too-important-to-fail product classes? GxP assert controls over a variety of quality-critical conditions, including:
Something that is traceable can be tracked through its various stages of progress or development.
In the case of a pharmaceutical product, for example, GxP for traceability enables regulators to pinpoint the source of the materials, the location of manufacture, the machinery used in manufacture and the source of that machinery, and the different steps in the subsequent supply chain for the finished product.
If problems emerge, traceability allows organizations and regulators to trace the problems to their source.
Introducing accountability into a process is like traceability, but for the people involved—the participants, stakeholders, vendors, managers, and team members that are directly responsible for each stage in the process.
Accountability enables regulators to hold the relevant party responsible for any issues that arise—which means the organizations themselves must take that accountability seriously. They must implement their own systems of accountability management to set the team up for success and ensure the public that in the event of a problem, the accountable parties can be identified.
To be credible, data maintained by an organization must have integrity. Examples of data kept in the process of GxP include storage temperature, machine voltage, delivery dates, ingredient quantities, and much more.
The US FDA defines data integrity according to the ALCOA standard. That is, to have integrity data must be:
- Attributable. The data must be traceable to its source. Whether it was recorded by a person or a machine, you can point to that person or machine as the source of the data.
- Legible. The data must be able to be read and interpreted by competent human eyes.
- Contemporaneous. The data must have been recorded in a relevant time frame. For example, if a temperature reading at 8:30am was recorded at 8:30am, it is considered contemporaneous. If it isn’t recorded until 12:30 the next day, it is no longer contemporaneous.
- Original. The data is part of an original record, not a copy. Note that the digital “Copy/Paste” function (Ctrl-C/Ctrl-V) is considered to preserve the originality of data, as long as it gets copied from a digital original source.
- Accurate. The data can be verified to be correct and reliable.
GxP standards should produce repeatable results, leading to product consistency. Implementing thorough GxP helps assure regulators and the public that one product is an accurate representation for the entire inventory, because the same standards have been applied to the entire inventory.
Ultimately, the most practical implication of GxP for heavily regulated organizations is the need to validate them to comply with those regulations. Failing to validate GxP can lead to regulatory consequences like fines or shutdown. It’s not a small consideration, and organizations in these industries need to be ready for it.
No one goes into business eager to implement good practices. Someone who enters a heavily-regulated industry does so to build aircraft, or to develop world-changing drugs, or to feed people high-quality food products. But GxP is crucial to success in these industries. Mastery of GxP is the outcome that leads to all the other outcomes.
This is not a CAPTIS article. Originally, it was published here.