A "c" or "C" is sometimes added to the front of the initialism. The preceding "c" stands for "current." For example, cGMP is an abbreviation for "current good manufacturing practice". The term GxP is frequently used to refer in a general way to a collection of quality guidelines.[1]
Purpose
The purpose of the GxP quality guidelines is to ensure a product is safe and meets its intended use. GxP guides quality manufacture in regulated industries including food, drugs, medical devices, and cosmetics.
The most central aspects of GxP are Good Documentation Practices (GDP), which are expected to be ALCOA:
Attributable: documents are attributable to an individual
Legible: they are readable
Contemporaneously Recorded: not dated in the past or the future, but when the documented task is completed
Original or a True Copy
Accurate: accurately reflecting the activity documented
and Permanent,
The products that are the subject of the GxP are expected to be
Traceability: the ability to reconstruct the development history of a drug or medical device.
Accountability: the ability to resolve who has contributed what to the development and when.
GxPs require that a Quality System be established, implemented, documented, and maintained.
As explained above, documentation is a critical tool for ensuring GxP adherence. For more information, see
good manufacturing practice.
^K., Nitahara (March–June 1993). "Good Automated Laboratory Practices and other standards: validation of computer systems in the PC environment". Qual Assur. 2 (1–2): 96–101.
PMID8156229.