Guideline for the validation of computer-aided systems in the pharmaceutical and food industries
It is important to us to fulfil the requirements of our customers perfectly or, at best, to exceed them and to guarantee a faultless operation of the plants. That is why we have been working according to the GAMP rules and regulations for about 25 years.
GAMP5 is a guideline for the validation of computer-aided systems in the pharmaceutical and food industry, published in cooperation with the International Society for Pharmaceutical Engineering (ISPE). This guide describes rules and procedures for quality assurance. GAMP5 is a useful standard set of rules on a voluntary basis.
An important principle of GAMP is that quality must be ensured in every stage of the manufacturing process. GAMP covers all areas of production - from raw materials, furnishings and equipment to staff training and hygiene.
Since February 2008 the current version 5 (GAMP 5) is valid, which contains a number of new features. The new guidelines pay particular attention to quality risk management, efficient use of resources and risk assessment. In addition, the risk assessment takes place throughout the entire product life cycle.