GMP Detox What is GLP and OECD and ICH guidelines

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  • 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"!

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