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.
Ready for GAMP5 in your company?
Our GAMP 5 consultants are up to date on the latest insights and make use of a pragmatic, risk-based approach – based on their expertise and industry best practices. We always start with a risk analysis, to investigate risks and determine the most important functions for testing. This way, 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 projects. We are able to guide your company during validation processes, or completely carry out your project from A to Z, including 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 term and long term projects – internal or external. By playing an active and coaching role, we provide validated systems that satisfy every aspect of compliance.
Interested? Contact us to discuss your project.
Want to expand your knowhow on GAMP5?
Our two-day GAMP5 training will give you the most important insights into the various aspects of GAMP5. Check out the program and register here.
Contact us to discuss your project