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Guideline

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Q10 Pharmaceutical Quality System
Short Title:Q 10
Internet:http://www.ich.org/LOB/media/MEDIA3917.pdf
Origin/Publisher:ICH Secretariat, c/o IFPMA, 30 rue de St - Jean, P.O. Box 758, 1211 Geneva 13, Switzerland; http://www.ich.org
Content:TICH Q10 describes one comprehensive approach to an effective pharmaceutical quality system that is based on ISO concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”
Status:Step 4
Document Type:ICH Guideline