CPPM for effective multivariate risk modeling for life cycle management

Matej Janovjak, John Cunningham, Adam M. Fermier, Steve J. Mehrman, Roger Holenstein

Research output: Contribution to journalArticlepeer-review


Regulatory initiatives  such as ICH Q8, Q9, Q10, and effective process and product life cycle management (LCM) highlight the need for a science-based causal and mechanistic understanding of all up- and downstream processes to ensure the development and manufacture of a safe and effective product. This requires new levels of process and product knowledge, the ability to master the variability of relevant sources, and understand relationships between the process and product, as well as knowledge of all associated risks and their effect on product quality (Figure 1).

Original languageEnglish
Pages (from-to)82-90
Number of pages9
JournalPharmaceutical Engineering
Issue number4
Publication statusPublished - 1 Jul 2016
Externally publishedYes


  • life cycle management
  • LCM
  • Science-based modeling
  • causal process and product mapping
  • CPPM
  • risk management
  • pharmaceutical manufacturing


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