What is GAMP5?
GAMP 5 (GAMP®5), or ‘Good Automated Manufacturing Practices’ is a non-mandatory legislation for pharmaceutical and food companies. It provides important guidelines for companies involved in the development and/or implementation of automated systems.
In essence, GAMP 5 refers to a structured approach for the validation of automated systems. The 5th version of GAMP puts more emphasis on risk management and quality management. There is currently no 6th version in the works. Companies that apply the GAMP 5 guidelines can ensure the quality of their automated systems. It also makes it easier to pass audits and government inspections.
Do you have any questions about Gamp 5 or MES?
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MES in the food industry
The conviction that an MES is necessary immediately raises a new question: What steps do we need to take to implement MES successfully? This white paper is based on many years of experience with MES in the food industry and with every project new insights are added and our approach is refined.
Part 1: What can a MES do for you?
Part 2: How do you successfully select and implement a MES?