GAMP 5® – Good Automated Manufacturing Practises
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 a mandatory legislation, it provides important guidelines for companies involved in the development and/or implementation of automated systems. Let’s explain GAMP 5®.
What is GAMP 5®?
GAMP 5® (ISPE) can be regarded as a structured 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 is more on risk control and quality management.
By correctly interpreting and applying the GAMP 5® guideline, companies working in regulated industries can ensure automated systems quality. It also becomes a lot easier for them to pass audits and government inspections. QbD has an extensive knowledge base and experience related to GAMP 5®. Among others, we help companies to:
- ensure that automated systems and processes that are to be delivered, are clear;
- implement a system life cycle approach from a quality perspective;
- make the activities of the life cycle scalable;
- apply scientifically based risk management;
- leverage as much knowledge and as many documents from suppliers as possible.
Ready for GAMP 5® in your company?
Our GAMP 5® experienced consultants are up to date on the latest insights (including Data Integrity, outsourced systems, artificial intelligence and machine learning) and make use of a pragmatic, risk-based approach – based on their expertise and industry best practices. We work in the most efficient way possible and we help you focus on product quality and patient safety while reducing validation costs. Together, we tackle possible gaps to make your quality system more robust and audit-proof.
QbD offers consultants for various kinds of assignments. We are able to guide your company during validation processes, or completely carry out your project from A to Z, including planning, testing and writing documents like user requirements. If you are not sure if your system needs to be validated, we advise you on the best approach and working method. In short, we offer GAMP 5® consultants with the right experience and skills for short and long-term projects – internal or external. By playing an active and coaching role, we provide validated systems that satisfy every aspect of compliance.
Want to expand your knowhow on GAMP 5®?
Our two-day GAMP 5® training will give you the most important insights into the various aspects of GAMP 5®.