Production systems for the pharmaceutical and food industries have to comply with ever-stricter legislation, including regulations of the European Medicine Agency (EMA) and Food & Drug Administration (FDA). Although Good Automated Manufacturing Practice (GAMP) is not legislation, it’s an important guideline for companies involved in the development and/or implementation of automated production systems.
GAMP ® (ISPE) can be regarded as a structured and project-based approach for the validation of (automated) systems. Currently, version 5 of GAMP (GAMP 5) has a definitive status, with no version 6 in the pipeline. Compared to previous versions, the emphasis of GAMP 5 is more on risk control and quality management.
By correctly interpreting and applying the GAMP 5 standard, companies working in regulated industries can ensure the required quality. It also becomes a lot easier for them to pass audits and government inspections. QbD has an extensive knowledge base and experience regarding GAMP 5. Among others, we help companies to:
- ensure that the to be delivered products and processes are clear;
- approach the life cycle of systems from a quality system;
- make the activities of the life cycle scalable;
- apply scientifically based risk management;
- reuse as much knowledge and as many documents from suppliers as possible.
QbD has several GAMP 5 consultants available and also offers GAMP 5 training for companies, small groups and individuals.