《Lean manufacturing practice in 》.pdfVIP

Lean manufacturing practice in a cGMP environment This article explores the introduction of lean manufacturing into the pharmaceutical sector and identifies the challenges that result. eveloped in the 1950s as a means to survive and compare these two manufacturing environments and Anne Greene compete against the giants of the automotive identify areas of overlap, together with challenges Dermot O’Rourke D sector, lean manufacturing helped Toyota evolve from pharma may face in moving towards lean a small-volume producer (with little capital) to become manufacturing. a high-volume manufacturer in a process-rich environment. Toyota achieved this by using Comparison of cGMP and lean developments such as total production maintenance GMP has evolved gradually, however the recent (TPM), just-in-time (JIT), Kanban, value stream mapping scientific risk-based framework and the process and Kaizen events.1 A summary of some of the lean analytical technology (PAT) initiatives, developed by terminology is shown in Table 1. regulatory authorities to support innovation and The pharmaceutical industry, manufacturing in a efficiency in a cGMP environment, suggest a new way current good manufacturing practice (cGMP) of thinking for the 21st century.2 environment, has been slow to adopt lean Since 2001, regulatory authority policies have manufacturing — unlike many sectors where it has promoted initiatives designed to increase the been successfully deployed. This article attempts to availability of new and affordable medicines. This new subscribe at I 1 Greene and O’Rourke thinking should help the environment can have both regulatory manufacturing as a