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.
Related Guidance Documents
Commissioning & Qualification (1)
Lifecycle Management (2)
Microbiological & Viral Contamination Control (1)
Process Analytical Technology (2)
Quality by Design (5)
- Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
- Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition
- PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles
- PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
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Webinars Related to Quality by Design
Videos Related to Quality by Design
iSpeak Blog Posts
Training Courses Related To Quality by Design
First Principles to Improve Pharma Manufacturing Operations Training Course
This course will show how First Principles-based approaches will provide a valuable tool to help create such control strategies. Drawing on examples from over 30 years’ experience in the pharma industry, the attendees will see what First Principles are and how not using a First Principle approach can lead to poor problem solving and even significant disasters.
Process Validation Training Course
This training course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System.
Turning Quality by Design (QbD) into a Practical Reality Training Course
Through group exercises, this course on Quality by Design will delve into implementation and operation of an effective and efficient control strategy in manufacturing, which is a key element of process performance and product quality monitoring and continual improvement.
Facilities Management Training Course
This interactive course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program.
Concept and Discussion Papers
March / April 2024
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Pharma 4.0 – Towards IT/OT Architectures for Prescriptive Maintenance
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Process Events for the Life Science Industry - Information Model Concept on OPC UA for Alarms and Audit Trails
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