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Working Party on Quality by Design

What is Quality by Design…?


… is “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management”

… is a quality management method for pharmaceutical production industry

… is an evolving international standard for pharmaceutical development of APIs and products following:

•     ICH-Guidelines Q8, Q9, Q10, Q11 and Q12

•     GAMP GMP Guidelines and Annexes

•     Guidelines towards systematic development process

… uses Quality Risk Management and scientific understanding for selection, specification and control of

•     critical Process Parameters (cPPs) & critical Material Attributes (cMAs)

•     affecting critical Quality Attributes(CQAs)

… provides guidelines for compiling data/information in relevant parts of the application file

… is applied to and affects life cycle management in order to

•     Decrease Time-to-Market

•     Optimize quality and costs

o     Less OOS

o     Control strategy

o     Knowledge-management

o     Data Integrity

•     Regulatory Flexibility

o     Post Approval Change Management Protocol

o     Real Time release Testing


© DECHEMA e.V. last update July 04, 2016