The term GxP is a generalization of quality guidelines, predominantly used in the pharmaceutical industry.
• Good Manufacturing Practice, or GMP
• Good Engineering Practice, or GEP
• Good Laboratory Practice, or GLP
• Good Safety Practice, or GSP
• Good Clinical Practice, or GCP
• Good Distribution Practice, or GDP
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.
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:
Traceability: the ability to reconstruct the development history of a drug.
Accountability: the ability to resolve who has contributed what to the development, and when.
Documentation is thus the most crucial instrument.
• Good Manufacturing Practice, or GMP
• Good Engineering Practice, or GEP
• Good Laboratory Practice, or GLP
• Good Safety Practice, or GSP
• Good Clinical Practice, or GCP
• Good Distribution Practice, or GDP
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.
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:
Traceability: the ability to reconstruct the development history of a drug.
Accountability: the ability to resolve who has contributed what to the development, and when.
Documentation is thus the most crucial instrument.
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Last Updated: January 20, 2007
Last Updated: January 20, 2007
