Process Validation: Thoughts on a New Guidance for an Old Issue
Nigel Smart discusses the FDA Process Validation Guidance that was issued in January 2011.
Read MoreAuthor: Nigel J Smart PhD
Metrics and their Importance in Lean Biomanufacturing
There is no doubt that metrics are an important component of any well run pharmaceutical process. Without knowledge derived from the data that details the critical process parameters, it is like running blind into a storm...
Read MoreChange Management; A Vital Part of the Lean Mechanism within the Life Sciences Industry.
The deployment of any successful Lean initiative will be largely dependent upon the capacity of the organization to adopt the changes that are part of the overall approach and a major driver for this will be how the workforce...
Read MoreEliminating Pharmaceutical Manufacturing Chaos through Implementation of an Effective 5S Program
From our experience most mature pharmaceutical plants contain equipment which is unused or stored within the confines of the “active manufacturing space” where the chemical/biochemical process is operating. In most cases this is...
Read MoreVisual Factory Methodology to improve Lean Manufacturing in Life Science Product Companies
When employing a Lean approach to pharmaceutical (Life Science) manufacturing, the implementation of a Visual Factory Methodology as part of the approach can have a very significant impact. The goal of Visual Factory...
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