What is a GxP?

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.

GxP is a general abbreviation for the “good practice” quality guidelines and regulations. The “x” stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP.

G: Stands for good
x: Variable
P: Stands for practices

The variable “x” depends on the application of the standards. The value of x can be M for “Manufacturing”, C for “Clinical”, L for “Laboratory”, S for “Storage”, D for “Distribution”, R for “Review”

The Guidelines mainly focus
▪️ 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.

Why is GxP Important?
Since the regulations of GxP are global, every company manufacturing life sciences product is affected by it. Therefore, meeting the GxP requirements is highly important. Though there are several GxPs, few of them are highly important for the life cycle of any product.

Good Manufacturing Practice (GMP) – GMP are the guidelines recommended by agencies for the authorization and control of manufacturing of products such as drugs, medical devices, active pharmaceutical ingredients (APIs) etc. Adhering to these guidelines assure the agencies about the quality of the products and that the manufacturers have taken every possible measure to ensure the safety of the product.

Good Clinical Practice (GCP) – GCP are international quality standards defined by the International Conference on Harmonization (ICH) that state the clinical trial regulations for the products that require testing on human subjects. The standards outline the requirements of a clinical trial and the roles and responsibilities of the officials involved in it. It ensures that no human experiments are performed just for the sake of medical advancement.

Good Laboratory Practice (GLP) – These are the standards set by the FDA for non-clinical laboratory tests and studies conducted for assessing the safety and efficacy of the product. GLPs are a set of standards which define the framework for a non-clinical study and states how they should be performed, evaluated, reported etc.

Good documentation practices (GDP) are a set of best practices for documentation and recordkeeping. They help preserve the data integrity of documents.

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