It can be challenging for consumers to establish and verify the quality of products they use or consume. That’s even more challenging when it comes to products that can significantly affect their safety, health, and well-being, such as medicines.
Instead, consumers must count on distributors and manufacturers to adhere to a strict set of best practices to produce, store, and deliver consistent quality and safe products. These best practices, collectively called GxP (Good Practices), entail a broad range of policies, regulations, and guidelines they must follow to ensure quality and consistency and to meet the requisite regulatory requirements.
Continue reading to get the details on GxP compliance. In this article, we focus on how these good practice guidelines apply to highly regulated industries, ranging from pharmaceutical to aerospace and manufacturing.
Spotlight on GxP Guidelines
Manufacturers and distributors often vigorously seek out tactics and strategies they can use to improve internal metrics like profitability, sales, and productivity. But who’s out to protect the interests of consumers? That’s precisely why GxP guidelines exist.
GxP guidelines are generally put into motion in processes in which the final product directly impacts consumers. A good example is during the production, storage, and distribution of food, medical devices, and pharmaceuticals. Failure to follow these guidelines can put consumer safety and health at risk.
Good practices are also commonly applied in situations in which high quality is essential to performance and safety. A classic example would be the aviation industry, where safety and security are essential to the industry. If an aircraft maker like Boeing doesn’t follow GxP guidelines, the consequences can be devastating for the airline industry as a whole.
The x in GxP is a variable that denotes the specific space in which the good practices are applied. According to Dickson, pharmaceutical companies must follow multiple sets of regulations specific to areas such as manufacturing (GMP), clinical trials (GCP), documentation (GDP), and laboratories (GLP).
No matter which fields these good practices are used in, universal themes pop up across the board. Adhering to these standard guidelines is an essential step towards ensuring product security and safety in all critical areas, from research and manufacturing to storage and distribution.
The Three Pillars of GxP Systems
GxP systems are designed to ensure compliance at their core, but they all revolve around the three key pillars: data integrity, accountability, and traceability.
The whole process of manufacturing and distributing a product must be traceable. The onus is, of course, on the manufacturers and distributors to record and document enough information to retrace the whole process. For instance, they must maintain verifiable records regarding environmental conditions, process validation, equipment qualification, and raw materials.
Accountability builds upon the principle of traceability. It calls for maintaining proper records and documentation to identify the personnel involved in a specific process. More importantly, they must verify that all personnel involved in generating a product are qualified and well-trained. For instance, a good practice would be to log the operator of a specific piece of critical equipment, and to always have available a complete record of their qualifications and training.
Data integrity is the wrap-around principle that ties together traceability and accountability. The FDA stipulates that data meant for GxP compliances must be Attributable, Legible, Contemporaneous, Original, and Accurate (hence the ALCOA rule). Importantly, organizations must also put in place proper data security measures, an absolutely essential aspect of business today, considering that the average cost of a data breach is a staggering $4.24 million in 2021, according to Bloomberg.
Which Industries Must Follow GxP Guidelines?
1- Pharmaceutical Industry
GxP guidelines are used heavily in the pharmaceutical industry, where they are vital for ensuring the safety and integrity of drugs and vaccines. Pharma companies must follow these guidelines to comply with the industry standards and FDA regulations.
They apply to nearly all stages of a pharmaceutical product lifecycle, from research and development to distribution to consumers. The most crucial pharma GxP guidelines include:
- Good clinical practices (GCPs): These guidelines cover clinical trials on humans. For example, vaccine makers like Pfizer and Moderna followed strict clinical trial guidelines during human testing of their vaccines. Thus, their Covid-19 vaccines received FDA emergency use authorization and, later, approval.
- Good laboratory practices (GLPs): Unlike GCPs, these guidelines only cover non-clinical testing, encompassing processes that take part during the discovery phase.
- Good manufacturing practices (GMPs): This set of regulations cover general manufacturing in the pharmaceutical sector.
Other good practice guidelines that they must follow include good distribution (GDP) and good storage (GSP) practices.
2- Food and Beverage
GxP guidelines are also used heavily in agriculture and food industries to prevent cross-contamination and foodborne illnesses, as well as meet regulatory requirements. For instance, under FDA-sanctioned GxP principles, anyone who handles food must be qualified and fully trained. There are also good practices explicitly set for vegetables and fruits, which must meet both the USDA and FDA regulations.
3- Medical Devices
In the U.S., it’s the responsibility of the FDA to make sure that the GxP guidelines are followed strictly by organizations that deal with medical devices. In most cases, good manufacturing practices apply, but medical device companies must also follow good laboratory, storage, and distribution practices in certain situations.
Aviation companies must follow specific GxP guidelines designed to ensure the airworthiness and safety of aircraft. There are good practices geared towards maintenance companies, distributors, part suppliers, and OEM’s. These guidelines are often harmonized with more comprehensive industry standards and programs devised to reduce operational costs and optimize manufacturing efficiency.
For instance, major GxP guidelines for the aviation industry are integrated into the core AS9100 standard. At the same time, AS9120 and AS9110 standards apply specifically to aerospace distribution and repair, respectively. The more detailed GxP guidelines are set and published by the U.S. Federal Aviation Administration (FAA).
Heavily regulated industries must go above and beyond to understand, implement, and maintain proper GxP standards effectively to ensure consumer confidence, safety, and quality. Moreover, rigorous GxP guidelines and regulations have already been put in place by regulatory agencies like the FDA, FAA, and USDA, providing organizations with a practical roadmap towards achieving compliance.