Automated production systems for the pharmaceutical and food industry must comply with increasingly stricter regulations. Every company producing for the European or American market is subject to the laws of the EMA, FDA and / or local legislations such as FAGG. These include GxP, 21 CFR Part 11 and / or Annex 11. Aside from the legislations, the technologies and possibilities used keep evolving at an increasing speed. Systems are integrated with each other, creating a more complex landscape, which could not be imagined before.
ISPE’s GAMP (Good Automated Manufacturing Practice), is not another legislation, but a practical interpretation of the legislations and is seen as a structured and project-based approach for validating (automation) systems. GAMP5 does not propose one-size-which fits all systems, but a framework, which can adapt from the simplest standalone system to a fully automated, integrated landscape for an entire production site.
Intended Audience: anyone that is involved in the use or validation of GxP critical systems
By the end of this TRIUM Training you should be able to:
- Explain what is GAMP5.
- Describe the 5 main principles of GAMP5.
- Explain what GAMP5 could benefit you.
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.