🔬 What is GLP? Simple question? Good Laboratory Practices (i.e. US FDA 21 CFR Part 58, ICH M4, EMA - [ Ссылка ])
🗿 Does it also apply to the QC laboratory at a GMP / CGMP site?
✅ Where is the link in ICH? And what is the ICH? Is it required to add GLP study reports to the CTD? And if so, in which module?
✅ Do you know the OECD guidelines for GLP? (OECD: [ Ссылка ])
✅ Are there GLP advisory guidelines for computer system validation, data integrity and cloud services?
📽 Let's see - here is the new GMP Detox session - today "GLP"!
