GMP Detox What is GLP and OECD and ICH guidelines
ฝัง
- เผยแพร่เมื่อ 4 ต.ค. 2024
- 🔬 What is GLP? Simple question? Good Laboratory Practices (i.e. US FDA 21 CFR Part 58, ICH M4, EMA - www.ema.europa...)
🗿 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: www.oecd.org/c...)
✅ 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"!