Key QbD Guidance Documents
ICH Q8(R2): Pharmaceutical Development
ICH Q9: Quality Risk Management
ICH Q10: Pharmaceutical Quality System
ICH Q11: Development and Manufacture of Drug Substances
FDA: Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach
FDA: Quality Systems Approach to Pharmaceutical CGMP Regulations
FDA: Process Validation: General Principles and Practices (Final Guidance)
Industry Case Histories and Related Materials
“ACE Tablets” Pharmaceutical Development Case Study
A-Mab: A Case Study in Bioprocess Development
“Sakura Tablet” Case Study Materials (NIHS, Japan)
Goals and Status of Mock Submission Document on Monoclonal Antibodie Products by EFPIA
EFPIA Draft Mock P2 Document for “Examplain” Hydrochloride (2006)
A Guide to EFPIA’s “Mock P2″ Document
PQLI Application of Science- and Risk-based Approaches to Existing Products
Quality by Design for ANDAs: An Example for Modified Release Dosage Forms
Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms
Related Resources
ICH Quality Implementation Working Group Training Materials
ICH Points to Consider Documents 1 (June 2011)
ICH Points to Consider Documents 2 (December 2011)
Q8, Q9, and Q10: Questions and Answers (FDA)
Q8, Q9, and Q10: Questions and Answers (EMA)
Quality Risk Management: Frequently Asked Questions
PIC/S Aide Memoire: Assessment of Quality Risk Management Implementation
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