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: PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
- 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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