GxP in Pharmaceuticals

One of the biggest concerns that the pharmaceutical industry constantly tries to address is the safety of its products. GxP is a set of regulations that aim to address this issue in a systematic and healthy way. The concept of GxP requirements in pharmaceuticals was established by the US Food and Drug Administration. The word itself encompasses many different rules in many different areas. What is GxP? G stands for “Good” and P stands for “Practice”. The ‘X’ in the middle is a variable that can be replaced with any word that correctly completes the abbreviation.

For example, ‘X’ is replaced by ‘M’ to make it GMP which stands for ‘Good Manufacturing Practice’. GxP extends to many regulated industries such as cosmetics and food as well as pharmaceuticals. GxP’s regulators are spread across the globe. Some popular regulators include FDA in the US, TGA in Australia and HS-SC in Canada.

So what is the main purpose of GxP? Simply put, it is a set of guidelines to ensure that products and services are safe To elaborate on this matter, GxP enforces regulated industries to adhere to very specific and secure manufacturing processes and storage procedures, ensure safe clinical trials involving human subjects and also establish effective research standards for non-clinical laboratory trials.

Distribution and publication of the above mentioned initiatives are also overseen by GxP. Popularly stated, GxP focuses on highly effective and efficient documentation. What exactly do these terms mean in the context of GxP? It refers to the clear establishment of various contributions to a particular product or study in part or as a whole. Everything is documented, including who contributed what and the impact of that contribution. Every step of the production process is documented as well. Thus, it becomes easy to track the origin of any product and every intermediate process is verified while manufacturing it.

Although GxP regulations include many diverse sets of controls, the most common are GCP, GMP and GLP. To get a better overview, we need to take a closer look at each of these regulations separately and understand the impact they have on the standardization process of the products and services we use every day.

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