1. About Good 'x' Practice (GxP)
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Regulatory frameworks apply throughout the entire product lifecycle, from early-stage development to post authorisation. GxP is an acronym that refers to the ‘good practice’ laws, rules and guidelines applicable to organisations that develop, test, manufacture and market or distribute products that are consumed or used by humans such as medicinal products [1] (hereinafter medicines), medical devices, medical software applications, cosmetics, or food products.
The “x” is the variable in GxP and covers a wide range of processes in the development, manufacture, and distribution of products. This lesson concentrates on the pharmaceutical area and deals with GxPs related to medicines predominantly.
The underlying quality rules and guidelines in the respective GxPs define the various ways companies in this highly regulated industry are required to ensure that their products for human use are of suitable quality and are safe, effective and usable . When companies deploy computerised systems for certain GxP processes, they must also implement a computerised GxP system, validated, and operated appropriately for the intended use of the system.
The main concepts that all GxP regulations share:
- Traceability: the ability to reconstruct a product’s entire development (or lifecycle) history, as well as that of each and every work item that contributed to its development.
- Accountability: knowing who was involved in the product’s development and manufacture, including when and how exactly did they contribute.
- Data integrity: a Quality Management system, called “Pharmaceutical Quality System (QPS)”, ensuring Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA), complete, consistent, enduring, and available (ALCOA+ [1] ) data.
Of note: an increasingly used term for GxP is cGxP which stands for “currentGxP”. It means the current good manufacturing, distribution and other good practices specified by the US Code of Federal Regulations, the EU, PIC, ICH and WHO, and, as applicable, by any other Regulatory Authority. It represents the current thinking of the respective regulatory authority on a topic
[1] ALCOA is an acronym that defines the fundamentals for ensuring data integrity and critical elements of Good Documentation Practice (See section 2.6. ALCOA stands for “attributable, legible, contemporaneous, original and accurate”. ALCOA-plus (ALCOA+) adds additional emphasis on the attributes of being “complete, consistent, enduring and available”. Used by WHO, EMA, FDA, PIC/S(Pharmaceutical Inspection Co-Operation Scheme) and others
[1] The term "Medicinal Product" in the European Union approximately corresponds to the term "Drug Product" in the United States. Sometimes the term "Finished Product" is used instead.
The term "Active Substance" or “Active Pharmaceutical Ingredient (API) in the European Union corresponds to "Drug Substance" in the United States. Within EUPATI the term “drug” is used for “substance” or API.