INTRODUCTION
About GxP requirements and its importance
GxP is a general abbreviation for the “Good Practice” quality guidelines and regulations. The “G” stands for Good “x” stands for various fields, including the pharmaceutical, lifesciences, agricultural, clinical, laboratory, manufacturing and food industries. GxP is a set of regulations and quality guidelines formulated to ensure the safety of life
sciences products while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution. The GxP standards were established by the US Food and Drug Administration (FDA) for a range of compliance related activities. The purpose of the guidelines is to ensure that the regulated organizations comply with the standard processes of various functions.
The guidelines mainly focus on the following areas:
- Traceability – ensuring that the development history of the product can be reverse engineered.
- Accountability – Identifying the contribution of every individual involved in the development process.
- Data Integrity – Ensuring the reliability of data.
Data Integrity plays a very vital role in GxP requirements. Data integrity is the maintenance of, and the assurance of, data accuracy and consistency over its entire life-cycle and is a critical aspect to the design, implementation, and usage of any system that stores, processes, or retrieves data. According to the ALCOA principle, the data should have the following five qualities to maintain data integrity:
- Attributable. Each piece of data should be attributed to the person who generated it.
- Legible
- Contemporaneous
- Original
- Accurate
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