The Critical Process All Regulated Industries Need

23 May 2020
By Bryan Smyth
bryan@TheCork.ie

Many people have heard the term “good practices” or “best practices” and use them loosely. Some consumers, however, and even some enterprise leaders, don’t realise that there is nothing loose about these terms. While they mean different things to different industries, “good practices,” often shortened to GxP, are serious business to any enterprise that operates in a heavily-regulated industry.

The regulators themselves certainly aren’t joking around. For example, the US Food and Drug Administration (FDA) levies heavy fines for violations of GxP by companies within its regulatory purview, including but not limited to:

  • Pharmaceutical companies.
  • Food producers and distributors.
  • Medical device developers and manufacturers.

It actually gets worse, however. The FDA makes violations of GxP public through Form 483, which anyone can look up. This public shaming can result in a PR nightmare and a body blow to the brand trust and profitability of any business that lapses in its implementation of GxP.

Clearly every regulated business should think long and hard about how to avoid such lapses from happening. So what does it take to implement ironclad GxP?

First, some definitions: The “x” in GxP is a placeholder for a number of specific “Ps”. For example:

  • GDP—good distribution practices.
  • GLP—good laboratory practices.
  • GMP—good manufacturing practices.

A “c” can also be appended to the GxP abbreviation to denote a “most current” good practice. For example, cGDP would indicate “current good distribution practices.”

So what makes a practice “good?” GxP, at their best, make sure that consumers and end-buyers of the products produced by regulated industries are safe and effective. This can mean different things to different industries. Below are several examples.

Pharmaceutical Industry

Pharmaceutical companies depend on GxP to make sure they produce drugs that both perform as advertised and which do not do more harm than good. The FDA keeps the pharmaceutical industry on an increasingly short leash, issuing five times more GxP violations to pharma companies in 2018 than in 2015.

Adhering to GxP helps pharma companies:

  • Formulate and test new drugs in laboratories using GLP to create controlled and replicable conditions, including temperature, pressure, humidity, etc.
  • Manufacture drugs using GMP properly and to adequate potency, with an eye toward the proper calibration, voltage, and temperature/pressure conditions of manufacture.
  • Distribute drugs using GDP to ensure that they remain potent between the factory and the shelf, monitoring conditions like temperature, pressure, and humidity to which the finished drugs are exposed.

Medical Device Industry

The medical device industry receives as much scrutiny, if not more, than pharmaceutical companies as it integrates groundbreaking robotic and AI technologies to try and make better and better medical devices on the cutting edge. 

Regulators watch for medical device producers to follow GxP like:

  • Testing of devices under GLP, monitoring the voltage, resistance, and pressures created by various devices.
  • Manufacture of devices under GMP, checking the voltage, temperature, pressure, and humidity of manufacturing conditions to ensure the production of working devices.

Agricultural and Food Industry

Growers, processors, and distributors of food must comply with numerous GxP designed to prevent foodborne illness and ensure the safety and palatability of the food when it arrives on consumer shelves. This includes:

  • Distribution under GDP that maintains the temperature and humidity at which perishable food products are distributed.
  • Monitoring of the soil chemistry and temperature using GLP to ensure that food products are grown under safe conditions.

Aeronautical Industry

Consumers and end-buyers depend on aeronautical products like airplanes and helicopters to be safe to operate. Regulators watch for the aeronautical industry to comply with GxP that include:

  • Testing airplanes under GLP that monitors critical temperatures, pressures, voltage, and other conditions that ensure the safe operation of the airplane.
  • Manufacturing plane parts under GMP to ensure their durability and airworthiness, as well as safety. 

What Makes a Good Practice “Good?”

The above examples demonstrate the effects of properly-implemented and formulated GxP—safe food, safe drugs, safe airplanes, etc. It doesn’t, however, define the practices themselves. Is there any agreed-upon definition of GxP that regulated industries can use to craft their policies?

While they vary in specifics across industries, according to Dickson, GxP are generally understood to include three critical ingredients:

Accountability

A GxP demonstrates accountability when adequate records are kept of who did what—who was responsible for each task in the GxP chain. It is the company’s responsibility, in implementing this aspect of GxP, that each employee in the accountability chain is trained and qualified to be held accountable. Placing someone unqualified in the accountability chain is a GxP violation on the part of the manager who placed them there.

Traceability

Traceability refers to the ability of regulators and auditors to retrace the steps of the company and essentially recreate the entire procedure on paper. Every action or condition that gets recorded bolsters the traceability of a procedure, contributing to its effectiveness as a GxP. If all steps are recorded, including where they happened, when they happened, and who was accountable, hazards and failures can be traced to their source. Any action or condition that is not recorded weakens the GxP.

Integrity of Data

Both accountability and traceability depend on the recording of data. Integrity of data is the criterion that brings it all together. In order for accountability and traceability to mean anything, the data which records it has to be trustworthy. 

According to the FDA, data has integrity if it is complete, consistent, and accurate. The acronym ALCOA is often used to define the parameters of data integrity:

  • Attributable (traceable to the person or persons who recorded it)
  • Legible (able to be read and understood)
  • Contemporaneously recorded (recorded as soon as possible after the action or condition reading)
  • Original or true copy
  • Accurate

With much at stake in terms of regulatory consequences and public safety, “good practices” are more than just a good idea—they are essential to the function and well-being of every business that faces significant regulatory hurdles.

Critical to avoiding GxP violations is the accurate and reliable recording of data. Regulated industries cannot afford to scrimp or cut corners on the recording of their data. The alternative is an unpleasant lapse that could hurt both the company’s reputation and its bottom line.

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