International Conference on Harmonisation (ICH ) cGMP Guidelines
Q1A (R2) Stability Testing of New Drug Substances and Products
Q1B Photostability Testing of New Drug Substances and Products
Q1C Stability Testing for New Dosage Forms
Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Q2A Text on Validation of Analytical Procedures
Q2B Validation of Analytical Procedures: Methodology
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
Q8(R2) Pharmaceutical Development
Q9 Quality Risk Management
Q10 Pharmaceutical Quality System
Q8, Q9, and Q10 Questions and Answers
Q8, Q9, and Q10 Questions and Answers - Appendix Q&As from Training Sessions
The Global Harmonization Task Force
Guidance On Quality Systems For The Design and Manufacture of Medical Devices
Quality Management System - Medical Devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange
Final Documents for Both IMDRF and GHTF
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