CPPM for effective multivariate risk modeling for life cycle management

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

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 journal › Article › peer-review

Abstract

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 language	English
Pages (from-to)	82-90
Number of pages	9
Journal	Pharmaceutical Engineering
Volume	36
Issue number	4
Publication status	Published - 1 Jul 2016
Externally published	Yes

Keywords

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

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https://ispe.org/pharmaceutical-engineering/july-august-2016Licence: In Copyright

Cite this

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abstract = "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).",

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AU - Janovjak, Matej

AU - Cunningham, John

AU - Fermier, Adam M.

AU - Mehrman, Steve J.

AU - Holenstein, Roger

PY - 2016/7/1

Y1 - 2016/7/1

N2 - 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).

AB - 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).

KW - life cycle management

KW - LCM

KW - Science-based modeling

KW - causal process and product mapping

KW - CPPM

KW - risk management

KW - pharmaceutical manufacturing

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JO - Pharmaceutical Engineering

JF - Pharmaceutical Engineering

IS - 4

ER -

CPPM for effective multivariate risk modeling for life cycle management

Abstract

Keywords

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