An audit trail documents the correct execution of processes and strict compliance with all defined steps in a complete and electronic manner.
GxP stands for "Good Practices" and refers to a collection of guidelines, standards and regulations specifically developed to ensure quality and compliance in the production and manufacturing processes of the life sciences industry. These guidelines are crucial to ensure that products and processes are subject to strict quality controls
"L" stands for "Laboratory" (Good Laboratory Practice, GLP)
"C" stands for "Clinical" (Good Clinical Practice, GCP)
"M" stands for "Manufacturing" (Good Manufacturing Practice, GMP)
"D" stands for "Distribution" (Good Distribution Practice, GDP)
GxP (Good x Practice) is a quality standard that applies to various areas of the life sciences industries. These include, in particular, the pharmaceutical, medical device, biotechnology, chemical, food and cosmetics industries. In all these industries, the GxP guidelines ensure that products and processes meet strict quality and safety requirements in order to guarantee consumer protection and product efficacy.
The GxP guidelines are defined by authorities and governments and represent specifications for a compliant way of working. Two important examples are
As a rule, the monitoring authorities of each country are responsible for checking the defined GxP guidelines and taking the necessary measures in the event of non-compliance. In Germany, monitoring is the responsibility of the federal states.
The GxP requirements provide specifications for the working procedures at various "product stages, e.g. in cultivation (agriculture) and in testing (laboratory). The aim is to ensure that industrially manufactured products can be consumed safely. It is also about ensuring the integration of data that is relevant for product-related safety decisions.
In some cases, the abbreviation GxP is preceded by a "c" - it stands for "current". It is therefore a "current" or currently valid "good practice". Ultimately, there is no difference. It is purely an extension of information.
Yaveon 365 is an ERP software solution designed specifically for the process manufacturing industry. It aims to support companies in complying with GxP regulations.
The following features help with implementation:
An audit trail documents the correct execution of processes and strict compliance with all defined steps in a complete and electronic manner.
This article shows you how to master challenges and stumbling blocks in the process validation of computer systems with confidence.
Computer system validation describes a documented process that consistently ensures that software does what it was designed to do.