Implementing GxP can seem like a hassle for companies and organizations in heavily-regulated industries. Most practices you adopt are yours to customize to your business, but GxP are not. They will largely be dictated by regulatory oversight bureaus, and the burden for validating your compliance with those GxP falls on you.
It’s critical that you get this right, so let’s address some of the most common concerns. Here are five of the most common GxP questions, answered.
1. What does GxP mean?
GxP refers to “good practices.” At least, the “G” and the “P” do. What’s the “x” for? The “x” stands in for a variety of specific good practices that relate to the applicable organization or industry.
Examples of GxP include:
- GMP — good manufacturing practices.
- GLP — good laboratory practices.
- GCP — good clinical practices.
So what makes a practice “good?” It’s not just that it’s good business or produces good outcomes. GxP are the practices that regulators look for when they verify that a company produces products of sufficient quality that do not jeopardize public health and safety.
In other words, GxP is not optional. For organizations in heavily-regulated industries, they are mandatory to remain compliant. They are also critical to maintaining public trust in the output of those organizations.
It works like this: companies implement GxP, regulators validate that GxP are in place, and consumers rely on the word of regulators to consume the output of the regulated companies without fear. If public health and safety is compromised as the result of the company’s output, GxP includes systems of accountability to trace problems to the responsible party.
GxP also includes systems of data integrity, to make sure that data used by the organization and reported to regulatory bodies can be trusted.
2. In what industries is GxP necessary?
Generally speaking, GxP is necessary in industries that face stiff burdens of regulatory compliance, usually as a matter of public health or safety. We’re talking about industries that produce products that people ingest, use, or depend on for their ongoing health and survival.
Some of the most common examples include:
- Pharmaceuticals. Pharmaceuticals are typically ingested by the consumer. The consumer’s health or even their life may depend on the quality of the pharmaceutical, especially in the case of an antibiotic, steroid, vaccine, statin, chemotherapy, or other life saving medication. Pharmaceutical GxP are maintained and validated in the US by the US Food and Drug Administration (FDA); in Europe, pharma GxP are maintained and validated by the European Medicines Agency (EMA).
- Medical Devices. Similar to pharmaceuticals, many peoples’ health depends on the quality of their medical devices. For example, a pacemaker has to work correctly or the user might go into cardiac arrest and die. The medical device industry, therefore, is held to similar GxP standards by organizations like the FDA and EMA.
- Food and Agriculture. Few products can cause a major public health crisis like food products. Everyone ingests food, so the food had better be processed and handled safely—that is, according to the GxP maintained by regulators like the US Department of Agriculture (USDA) to prevent widespread sickness and even death.
- Aerospace. GxP is important to the aerospace industry because peoples’ lives depend on the integrity and airworthiness of the aircraft they step onto, whether as a passenger, crew, or pilot. The Society of Automotive Engineers (SAE) maintains aerospace GxP as part of AS9100, a series of regulatory controls modeled after the more standard ISO 9001. Every part of every aircraft must pass through organizations that comply with AS9100 and implement aerospace GxP laid out therein.
3. What are some benefits of GxP?
Heavily-regulated organizations reap critical benefits from implementing GxP, including:
- Regulatory Compliance. GxP is often required for regulatory compliance, which for heavily regulated industries makes the difference between keeping the doors open or closing up shop.
- Greater Public Trust. Consumers place a great deal of trust in the output of heavily-regulated businesses—willingness to swallow their products, to step on airplanes, and so on. Trusting that the companies behind those products follow GxP makes an enormous difference to consumer faith in your product.
- Systems of Accountability and Traceability. GxP ensures that any problems can be traced to the responsible party or source and then corrected.
- Greater Data Integrity. GxP also includes systems of data integrity, to ensure that the data records produced by an organization can be trusted.
4. What can happen if GxP isn’t implemented correctly?
If GxP is not properly implemented, the consequences can be quite serious. Examples include:
- Fines. If a regulated organization fails to validate GxP, regulatory agencies could levy stiff fines against the organization.
- Shutdown. At the most extreme end of consequences for failures of regulatory compliance, governing bodies could mandate that your organization be shut down until it can validate proper implementation of GxP.
- Public Health and Safety Crises. Failure of GxP could result in faulty or dangerous product output, endangering consumers—possibly on a massive scale.
- Loss of Public Trust. Being exposed for faulty GxP can cause customers to abandon an organization en masse, resulting in massive loss of revenue and a long road back into the public trust.
5. What are some organizational GxP best practices?
Examples of organizational GxP include:
- GDP—Good Data Practices. These involve the preservation of the integrity of data and apply to most regulated organizations. To have integrity, data must adhere to the ALCOA standard—that is, the data must be attributable, legible, contemporaneous, original, and accurate.
- GMP—Good Manufacturing Practices. GMP usually involves the implementation of a quality management system (QMS) to perform the functions of quality assurance in manufacturing. Other aspects of GMP include decontamination of facilities, manufacturing consistency, personnel training, and quality-checking of the final product.
Dickson has a GxP guide that goes into more depth on best practices.
GxP is a big topic, impossible to tackle for every industry in one article. However, by understanding the basics of GxP, you can start to implement GxP in your own regulated organization. Ultimately, inability to implement GxP is no reason not to pursue your ambitions to make a big impact in a regulated business. It’s part of the challenge, even part of the fun!