Quality Control Management

Download Applying lean six sigma in the pharmaceutical industry by Bikash Chatterjee PDF

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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 method. His consultant to operational excellence within the pharmaceutical and biotech industries is a concentrated precis of the applying of Lean Six Sigma idea 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 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 beginning for the foundations of caliber by means of layout, PAT and the recent philosophies underlying strategy Validation. every one bankruptcy contains dialogue round the concerns for utilising Lean production and 6 Sigma ideas and their instruments, culminating in a case learn to demonstrate the applying. The booklet is prepared to mirror the key paintings facilities interested by the drug improvement lifecycle. every one bankruptcy is stand-alone yet jointly they illustrate the mandatory synergy among Lean, Six Sigma and compliance sensibilities required to achieve success within the pharmaceutical undefined. those layout, production and administration concepts usually are not with out their demanding situations. Bikash Chatterjee's publication bargains the roadmap for an that's suffering to reinvent lots of its improvement and enterprise tactics.

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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.

2. In order to effectively apply a risk management framework, the technical and quality organization must consistently apply risk management tools to support its decision-making process. Six Sigma and Lean Kaizen efforts are based upon a structured and measurable approach to process characterization and improvement. Some of the risk management tools that can be applied along with their strengths and weaknesses are discussed in the following section. 2 ICH Q9 risk management framework 34 Applying Lean Six Sigma in the Pharmaceutical Industry Fault Tree Analysis (FTA) FTA is a team-based method used to identify the causal chain that creates a hazard or a failure mode (effects are typically ignored).

Focusing on water systems was a brilliant move on the agency’s part since water was used in almost every facet of the drug manufacturing and testing process. The decision to move away from unidirectional systems equipped with point-ofuse filters for microbiological protection and mandate recirculating systems which could demonstrate escalating level of water quality improvement hit industry in the pocketbook, getting their attention and spurring dialogue. The focus on computerized systems was an attempt to embrace the reality that automation and information management systems were becoming a larger and larger part of the drug development process.

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