GAMP / GXP
Good Automated Manufacturing Practice is a set of guidelines as to best practice for automated systems within a manufacturing environment. It was originally established within the pharmaceutical industry by the International Society of Pharmaceutical Engineering. The GAMP 4 Standard is designed to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry.
Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).
Workbench and GAMP/GXP
An extremely important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US). Workbench ensures this risk is avoided.