Pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and control based on sound science and quality risk management.
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Guidance Documents
Biotechnology (1)
+Commissioning & Qualification (1)
+Containment (1)
+Lifecycle Management (2)
+Microbiological & Viral Contamination Control (1)
+Process Analytical Technology (3)
+Quality by Design (6)
+Regulatory (2)
+Validation (1)
+Community Discussions
Community Discussions
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Dec 04, 2024
GAMP®
Lifecycle Management
Pharmaceutical Engineering Magazine Articles
iSpeak Blog Posts
Professional Development Training
ICH Q8: QbD in Manufacturing
+ICH Q10: Pharmaceutical Quality System (PQS)
+First Principles to Improve Pharma Manufacturing Operations Training Course
+Process Validation Training Course
+Turning Quality by Design (QbD) into a Practical Reality Training Course
+Facilities Management Training Course
+White Papers
May / June 2025
The ATMP Issue: In this issue, we focus on the manufacturing of advanced therapy medicinal products…
March / April 2025
A Skill Management Framework for a Pharma 4.0™ Workforce Feature: Pharma 4.0™ is driving fundamental…
January / February 2025
GAMP® is indispensable for safeguarding the safety, quality, and compliance of pharmaceutical…
