Technology has transformed every aspect of the world; form medical service provisions to communication; these enhancements greatly make life easier. However, everything that has benefits must, in a way, have its shortcomings. When it comes to computer technology, there is a lot of importance compared to the disadvantages. Computer systems have provided the world with a spectrum of options in undertaking certain responsibilities. The efficiency and accuracy of the computer are on another level. While everyone is allowed to use their computers as they wish, certain industries such as pharmaceutical and food industries using computer systems have to adhere to certain requirements set by regulators such as the FDA.
It is a requirement that companies in this field must ensure their computer systems undergo the GxP validation to ensure appropriate and monitored practices in the production of such high profile products. The main reason these regulations were set was to ensure all items produced in this industry. Food and drugs are among the most vital things a human being needs to live a sustainable life. While the pharmaceutical and food industry has played a crucial role in stretching people’s life expectancy, nothing is left to chance as a slight issue in production could lead to terrible consequences. The best way to ensure compliance of the stipulated rules is for a company linked to the affected industry to ensure getting GxP validation services for its computer systems.
What Is GxP Validation
GxP validation is simply the assortment of quality requirements and guidelines developed to safeguard pharmaceutical and food products’ safety. This process ensures the related systems are apt to produce products that meet their intended purpose and quality. Additionally, GxP validation ensures the process from manufacturing, processing, and storage to distribution meets the setup guidelines. This concept was developed by the United States Food and Drug Administration (FDA) and focused on the effectiveness of certain research standards involving non-clinical laboratory and nontoxic human clinical trials. The regulations center on the following factors;
This validates the honesty and reliability of data given by the computerized systems. Various activities could determine a given system; one is by ascertaining the data produced by the systems in a critical process. Also, data integrity could get determined by stating the DI guidelines throughout a given data throughout the lifespan. Lastly, the systems’ integrity could get verified by conducting a risk and mitigation assessment, for instance, the technical controls to ensure no DI violations.
This majorly focuses on the aspects that have contributed to producing a given product concerning the compliance of the setup GxP system regulations. Accountability is also aimed at determining when the contribution got made.
This is crucial since it gives the ability to trail down every aspect of a given product to the core. For instance, one can trace every process involved in the manufacture, processing storage, and distribution of a given drug or medical item.
Who Is Targeted by GxP
Apart from the food and drug companies, other firms impacted by GxP include medical device production companies and cosmetics. There are GxP regulators worldwide; in the US, the FDA is in charge of ensuring that every associated company observes the stipulated guidelines. Australia has a regulatory body referred to as the Therapeutic Goods Administration (TGA) while in Canada; the HS-SC is mandated with that task. There are several GxP regulations across the world, but the most prevalent are Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
Good Manufacturing Practice
This regulatory aspect merges all the practices needed to adhere to the requirements as per the regulator’s recommendation that is authorized to control the licensing and manufacture of such products as drugs, food, cosmetics, and medical devices. The regulation outlines the threshold that each manufacturer should meet to ensure their products achieve the standard required for them to get sold in the market.
Good Clinical Practice
This practice is recognized internationally and is specified by the International Conference on Harmonization (ICH). Governments worldwide are required to adopt the predetermined clinical practice regulations into their guidelines, especially for trials involving the human subject. The medical sector is fond of using humans in the trials of advanced medicines and devices. We have seen this happen during the quest for COVID 19 vaccines. Researchers used people to find out whether their invented vaccines work or not. While the intention might be for a good course, regulations in the practice help prevent catastrophic occurrences such as the subjects’ death. Such high profile experimentations need to be controlled.
Good Laboratory Practice
While this relates to GCP, good laboratory practice involves non-clinical studies for chemical-based products intended for use by people, animals, and the environment in general. The regulation ensures that every step of the production process follows the guidelines put in place.
Outlines to Follow as a Producer
There are a million guidelines that all manufacturers of the stated products need to follow to ensure they do not face regulatory charges. In the Good Manufacturing Practices, the following are some of the outlined requirements that need to be met for products to be considered safe for the market;
- Hygiene and cleanliness of the areas where production takes place
- The area where the manufacturing process takes place should get controlled to avoid contamination of the product being produced.
- The entire manufacturing process must be distinct and properly controlled, and any changes need validation and approval from the regulator.
- The whole process of manufacture has to be recorded to prove compliance of all regulatory rules.
- In case a product turns out to be defective, thorough investigations need to be done to ascertain the causes and measures that could correct the situation.
The GxP assessment is an important aspect of ensuring the safety of the general public. There have occurred certain instances where people have suffered serious damage due to some pharmaceutical food products. This is why the regulations have been set to avoid such unprecedented events. It is important for companies dealing with such sophisticated products to engage GxP validation services from an authorized agent to ensure compliance with the setup rules.