Download e-book for kindle: Applying lean six sigma in the pharmaceutical industry by Bikash Chatterjee

By Bikash Chatterjee

ISBN-10: 0566092042

ISBN-13: 9780566092046

ISBN-10: 1472425219

ISBN-13: 9781472425218

ISBN-10: 1472425227

ISBN-13: 9781472425225

Bikash Chatterjee emphasizes the criticality of utilizing the rules of Lean and 6 Sigma in the paradigm of the drug improvement technique. His consultant to operational excellence within the pharmaceutical and biotech industries is a centred precis of the applying of Lean Six Sigma thought to the regulated existence sciences. From molecule discovery to the applying of PAT using Lean Six Sigma within the Pharmaceutical will spotlight the significance of framing those tasks in the key deliverables of drug improvement production and caliber. demanding traditional knowledge the writer bargains a high quality and potency point of view as a starting place for the foundations of caliber by means of layout, PAT and the hot philosophies underlying procedure Validation. every one bankruptcy contains dialogue round the concerns for utilizing Lean production and 6 Sigma rules and their instruments, culminating in a case examine to demonstrate the appliance. The e-book is prepared to mirror the most important paintings facilities eager about the drug improvement lifecycle. every one bankruptcy is stand-alone yet jointly they illustrate the required synergy among Lean, Six Sigma and compliance sensibilities required to achieve success within the pharmaceutical undefined. those layout, production and administration concepts aren't with no their demanding situations. Bikash Chatterjee's booklet deals the roadmap for an that's suffering to reinvent a lot of its improvement and enterprise tactics.

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Extra resources for Applying lean six sigma in the pharmaceutical industry

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When the maintenance team was asked to calibrate the air flow controller they reported that the system had a very large offset from the controller setpoint. A deeper investigation revealed the procedure used by the technicians was incorrect and did not account for the duct geometry in calculating the F-factor. Temperature mapping the unit revealed large temperature variations between the top and bottom shelves of the dryer. A closer look revealed the gasketing for the oven doors was completely worn away, leaking air from the ovens and the gasket on the bottom of the oven was never installed.

The RPN is used to prioritize mitigation actions for each identified risk. 6. Any OpEx initiative that does not start with a regulatory and compliance risk assessment has the potential to not only jeopardize the viability of the improvement but also could impugn product already in the field. These risk management tools will allow the organization to compartmentalize the risk so the data derived from the OpEx study can be used most effectively to achieve process stability and reduce compliance exposure.

It had participated heavily as part of the International Committee on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use which had attempted to consolidate best practices across the industry. Out of this effort came several landmark guidance documents which became the foundation for most global regulatory philosophy. Three critical guidance documents were ICH Q8, ICH Q9, and ICH Q10. ICH Q8 provided guidance in terms of the Pharmaceutical Development section of an ICH regulatory submission.

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Applying lean six sigma in the pharmaceutical industry by Bikash Chatterjee

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