GMP Detox What is GLP and OECD and ICH guidelines скачать в хорошем качестве

GMP Detox What is GLP and OECD and ICH guidelines

🔬 What is GLP? Simple question? Good Laboratory Practices (i.e. US FDA 21 CFR Part 58, ICH M4, EMA - https://www.ema.europa.eu/en/human-re...) 🗿 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: https://www.oecd.org/chemicalsafety/t...) ✅ 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"!