Good Automated Manufacturing Practice, GAMP, är något som vi på Plantvision Compliance verkligen har erfarenhet och kunskap inom. Som experter inom datoriserade system tillhör vi det absoluta toppskiktet, både i Sverige och i Europa. Vi vet, helt enkelt, hur man tillämpar GAMP 5 på allra bästa sätt. Kanske behöver du en GAP-analys av ett eller flera system för att se hur ni förhåller er till nya GAMP 5 Second edition? Eller en utbildning för att kunna vara i framkant? Tack vare den kunskap vi besitter kan vi hjälpa dig och ditt företag med utbildning som skräddarsys efter behov – eller så fungerar vi som en kunskapspartner. Eller både och.
Branschorganisationen ISPE, släppte i juli 2022 en ny upplaga av, Good Automated Manufacturing Practice, (GAMP), den globala riktlinjen för validering och kvalitetssäkring av kvalitetskritiska datoriserade system inom Life Science. GAMP 5, Second Edition, bygger i stort på samma övergripande principer för datoriserade system inom GxP som beskrivits i den tidigare GAMP 5-upplagan som gavs ut 2008.
What is the difference between first and second edition?
One reason why the GAMP guidelines have been so successful globally and have become a kind of industry standard for both life science companies and life science suppliers is that they have continuously reflected existing technology developments. Innovation and technological advances in recent years have led to the need to review and update the guideline.
Some of the changes made in GAMP 5 Second Edition include support for agile and iterative approaches and now both linear and iterative approaches are described for several types of processes. The new edition also addresses and encourages the increased use of system and software tools instead of traditional paper-based documentation for information, requirements, specifications, testing and traceability, etc.
The Second Edition of GAMP 5 continues to describe risk-based thinking at all stages of a system's life cycle, as part of aligning the activities that need to be performed to ensure that a quality-critical system is Compliant. A further update is that it includes clarification that an initial risk assessment should be carried out before the project phase and that risk assessment should then be carried out continuously during the project and throughout the system's continued life cycle. The new edition also includes guidance on the application of artificial intelligence (AI), machine learning, blockchain and cloud solutions, which is a good complement to the previous edition.
2 quick questions for one of our wizards
Vi fick möjligheten att prata lite med Lina Stange, Senior Expert Consultant på Plantvision och en av våra wizards på just GAMP 5 och allt vad den innebär.
What do we need to do differently now that the new edition has arrived?
- The new edition offers more opportunities, but also places higher demands on risk assessment and critical thinking. For example, we can help the customer to do a GAP analysis against GAMP 5 2nd edition.
Do authorities require us to adapt our ways of working to GAMP 5 2nd edition?
- GAMP5 is not a regulation, but several regulatory authorities, including the FDA, have "recognized" GAMP 5 and some adaptations will be needed.
Do you want to know more about the GAMP 5 guidelines, what the new version might mean for you, or do you need support, training or analysis of the system? Do not hesitate to contact one of our experts!
NEW!
GAMP 5 Second Edition as interactive E-learning
We have now released a unique and groundbreaking GAMP 5 Second Edition training course! A three-hour interactive training that will teach you everything you need to know about the new edition. Smart and smooth, right?