GxP

The concept of GxP requirements was established by the US FDA (the United States Food and Drug Administration) for a range of compliance-related activities and GxP stands for:

GxP is a set of regulations and quality guidelines that aim to address the safety of the pharmaceutical product in a systematic and wholesome manner while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution.

The variable “x” can stand for different fields depending on the application of the standards. “x” can be GMP for “Manufacturing”, GCP for “Clinical”, GLP for “Laboratory”, GSP for “Storage”, GDP for “Distribution” or “Documentation”, GAMP for Automated Manufacturing, GRP for “Review”, etc. The most common ones are GMP, GLP, and GCP.

In addition to the above-mentioned GxP, a few others exist such as GEP (Good Engineering Practice), GAP (Good Auditing Practice), and GRP (Good Review Practice). These standards are not talked about very frequently although they have a significant impact on the pharmaceutical industry.

To get a better overview, we need to take a closer look at each regulation and understand what impact they have on the standardization procedures of the products and services we use every day.

The purpose of the guidelines is to ensure that the regulated organizations comply with the standard processes of various functions. They are mostly similar across all the countries and mainly focus on areas as follows:

• Traceability – ensuring that each stage of the production process (such as development, manufacturing, and release) records can be traceable.

• Accountability – Identifying the contribution of every individual involved in each stage of the production process.

• Data Integrity (DI) – Ensuring the reliability of data. DI could be determined by the following activities:

Regulated industries such as food, pharma, medical devices, and cosmetics are impacted by GxP. GxP guidelines and regulations are global; some of the popular regulators include FDA in the US, TGA in Australia, and HS-SC in Canada. As the regulations of GxP are global, every company in regulated industries is affected by it. Therefore, meeting several GxP requirements for the life cycle of any product is extremely important.

Related links:

• GAMP 5 for GxP Compliant Computerized Systems
• GxP Compliance: The Importance of Employee Training Automation
• Using SaaS solutions in GxP compliant industries
• Requirements of a Quality Management Software for the pharmaceutical industry