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This is about the pharmaceutical term. If you are looking for the anime, see: Tenchi Muyo! GXPThe term GxP is a generalization of quality guidelines, predominantly used in the pharmaceutical industry. GMP is the most commonly known instance of GxP. The term GxP is only used in a casual manner, to abstract from the actual set of quality guidelines.
Purpose The purpose of the GxP quality guidelines is to ensure a quality product, guiding pharmaceutical product research, development and manufacturing, but also presents a codex for much of the activities off the critical path. The most central aspects of GxP are: Consequences of GxP in Information Technology|IT For the drug to be produced in a truly GxP compliant manner, these guidelines must also be applied for anything that contributes directly or indirectly to its development. This includes anything used in handling information. The pharmaceutical industry therefore must heed various things that are somewhat neglected in other industries. The business case for any overhead in technical measures in this field is easily made, if one considers the importance of winning some of the most spectacular litigation cases that are attributed to the pharmaceutical industry. This is also the perspective that you should use to understand the sense and nonsense of high investments in your IT security concept (IT infrastructure, standard operating procedures for system administration). At the same time, system development in the pharmaceutical industry needs more attention than usual on its record-keeping. Traceability is of central importance, creating a chain of decisions that lead from user needs and business goals down to the design decisions of the system, and the qualification of its installation and operation. See also | ||||||||
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