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By Bikash Chatterjee

Bikash Chatterjee emphasizes the criticality of utilizing the foundations of Lean and 6 Sigma in the paradigm of the drug improvement approach. His advisor to operational excellence within the pharmaceutical and biotech industries is a centred precis of the appliance of Lean Six Sigma thought to the regulated existence sciences. From molecule discovery to the appliance of PAT making use of Lean Six Sigma within the Pharmaceutical will spotlight the significance of framing those projects in the key deliverables of drug improvement production and caliber. tough traditional knowledge the writer bargains a top quality and potency standpoint as a origin for the foundations of caliber via layout, PAT and the recent philosophies underlying procedure Validation. every one bankruptcy comprises dialogue round the issues for employing Lean production and 6 Sigma ideas and their instruments, culminating in a case learn to demonstrate the applying. The publication is equipped to mirror the key paintings facilities curious 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 will not be with out their demanding situations. Bikash Chatterjee's publication bargains the roadmap for an that's suffering to reinvent a lot of its improvement and enterprise strategies.

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Case Study—Resource Management A small molecule pharmaceutical manufacturer initiated a root cause exercise as part of a Corrective and Preventative Action program (CAPA) opened for a controlled release cardiovascular capsule that had been on the market for nearly ten years. A historical review of the product’s performance indicated the process stability had been poor from day one. The team adopted a Six Sigma type methodology for the investigation, mimicking the Define, Measure, Analyze, Improve and Control (DMAIC) roadmap.

The challenge with evaluating most non-conformities is understanding the full implication of the deviation. Without a clear mechanistic understanding of the relationship between the input variability, process control, and specifications it is nearly impossible to fully anticipate the full consequence of a deviation. An intermittent failure may be an isolated event or an early indication of equipment or process drift. The challenge for OpEx initiatives is to compensate for this knowledge gap. This often requires starting with fundamentals by mapping the product’s design criteria against the available data for the operational and quality systems.

This includes all preventive maintenance systems and calibration systems which apply to the facility and equipment. This is an often overlooked component to many OpEx initiatives. Understanding the procedures used for calibration and duty cycles used for maintenance that have been established for equipment and critical utilities can be an essential part of understanding the sources of 16 Applying Lean Six Sigma in the Pharmaceutical Industry variation in a process. If equipment stability cannot be established at the outset of an investigation it is nearly impossible to establish process predictability.

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