Anne Greene

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

This article explores the emergence of subjectivity in ICH Q9 (R1).

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

Developed in the 1950s as a means to survive and compete against the giants of the automotive sector, lean manufacturing helped Toyota evolve from a small-volume producer (with little capital) to become a high-volume manufacturer in a process-rich environment. Toyota achieved this by using developments such as total production maintenance (TPM), just-in-time (JIT), Kanban, value stream mapping and Kaizen events.1 A summary of some of the lean terminology is shown in Table 1.

Introducing lean manufacturing into the pharma sector.