ICH Q11 Presentation by Alex Weisman - The Israel Chapter of PDA

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Q11: Manufacturing process development should include, at a minimum…. • Identifying potential CQAs associated with the drug substance so that those characteristics having an impact on product quality can be studied and controlled; • Defining an appropriate manufacturing process; • Defining a control strategy to ensure process performance and drug substance quality; 12
Q11: Manufacturing process development should include, at a minimum…. An enhanced approach to manufacturing process development would additionally include the following elements: A systematic evaluation, understanding and refining of the manufacturing process, including; » Identifying, through e.g. prior knowledge, experimentation and risk assessment, the material attributes and process parameters that can have an effect on drug substance CQAs; » Determining the functional relationships that link material attributes and process parameters to drug substance CQAs; • Using the enhanced approach in combination with QRM to establish an appropriate control strategy which can, for example, include a proposal for a design space(s) and/or real-time release testing (RTRT). 13
Page 1 and 2: Q11 Development and manufacture of
Page 3 and 4: What’s new? • This guideline de
Page 5 and 6: • DS = Drug substance • DS = De
Page 7 and 8: Q11: Approaches to development •
Page 9 and 10: Q11 Development and manufacture of
Page 11: CQA’s with the reference to speci
Page 15 and 16: Material attributes and process par
Page 17 and 18: Q11: design space • For chemical
Page 19 and 20: Volume 15 14 13 12 11 10 9 8 -20 Q1
Page 21 and 22: Isomerization Stage - Reaction Surf
Page 23 and 24: Design space for manufacturing proc
Page 25 and 26: Q1: Description of Manufacturing Pr
Page 27 and 28: Selection of Starting Materials for
Page 29 and 30: Q11: Control Strategy 29
Page 31 and 32: Process Validation / Evaluation •

ICH Q11 Presentation by Alex Weisman - The Israel Chapter of PDA

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