CRED Getting the CMC Dossier Right 2024

28/08/2024

Design and Development Considerations

• Experience and data generated during pharmaceutical development, batch testing & stability studies can justify excluding/replacing some tests e.g.

Examples include testing for: • Microbiological quality in non-sterile products that do not support microbial viability/growth (ICH Decision Tree #8) • Extractables from product containers where no extractables are found in the drug product or the levels meet accepted standards for safety • IR dissolution testing for OSDs can be replaced by disintegration if DS is highly water-soluble and development data shows consistently rapid drug release (ICH Decision Tree #7)

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Limited Data Available at Filing

• Regulatory Agencies recognize limited data may be available at time of filing • Influences setting of acceptance criteria • May be necessary to propose revised acceptance criteria as experience is gained • Additional tests / tighter limits – generally Type IA “do and tell” notifications • Widening limits - generally Type II major variations

• ICH states basis for acceptance criteria at time of filing should focus on safety and efficacy • But agencies still base acceptance criteria setting on quality data, as well as safety and efficacy • Does this drive industry to provide ‘dirty’ batches in the filing to support wider limits? • Is PACMP a way forward to break the dichotomy?

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