Applying lean six sigma in the pharmaceutical industry - download pdf or read online

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 employing the rules of Lean and 6 Sigma in the paradigm of the drug improvement procedure. His advisor to operational excellence within the pharmaceutical and biotech industries is a targeted precis of the appliance of Lean Six Sigma conception to the regulated existence sciences. From molecule discovery to the applying of PAT utilizing Lean Six Sigma within the Pharmaceutical will spotlight the significance of framing those projects in the key deliverables of drug improvement production and caliber. hard traditional knowledge the writer deals a high quality and potency standpoint as a origin for the rules of caliber by way of layout, PAT and the hot philosophies underlying technique Validation. each one bankruptcy contains dialogue round the concerns for utilizing Lean production and 6 Sigma rules and their instruments, culminating in a case research to demonstrate the applying. The ebook is equipped to mirror the key paintings facilities interested in 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 ideas are usually not with out their demanding situations. Bikash Chatterjee's e-book bargains the roadmap for an that's suffering to reinvent a lot of its improvement and enterprise tactics.

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The agency knew this could not continue and began a wholesale transformation for defining acceptable drug development. One based on scientific understanding and risk management as a foundation for demonstrating safety and efficacy. The FDA launched its Critical Path Initiative in an effort to “lean out” the regulatory approval process. Specifically the objective was to modernize the techniques and methods used to evaluate the safety, efficacy, and quality of medical products as they move from candidate selection and design to mass manufacture through better predictive and evaluative tools: • innovative trial design, new statistical tools and analytic methods, use of modeling and simulation; • establishing and qualifying predictive biomarkers for specific conditions; • less stringent Current Good X Practice (cGxP)1 regulations for IND exploratory studies and clinical trials.

The guidance specifically states: “Under a quality system, senior management should incorporate a strong commitment 12 Applying Lean Six Sigma in the Pharmaceutical Industry to quality into the organizational mission. ” OpEx initiatives must frame their improvement initiatives with these policies and procedures in mind. Short of this it is highly likely the improvement initiative may fail or do more harm than good, generating deviations for non-compliance with existing procedures and policies. It is important to remember that most of the industry in the US has gone through several cathartic changes in terms of its quality philosophy, usually as a result of heightened FDA enforcement.

4. 5. 5 General Criteria Detection ranking table General Criteria ExplanaƟon Inspect Types DefecƟve Product Criteria Ranking Mistake Manual Proofing InspecƟon Almost Impossible Absolute certainty of non-detecƟon X Cannot detect or is not checked 10 Very Remote Controls have poor chance of detecƟon X Control is achieved with indirect or random manual checks only 9 Remote Controls have poor chance of detecƟon X Control is achieved with on-line manual inspecƟon only 8 Very Low Controls have moderate chance of detecƟon X Control is achieved with off-line manual inspecƟon or charƟng methods, such as SPC 7 Low Controls have moderate chance of detecƟon X Control is achieved with manual on-line charƟng methods, such as SPC 6 Moderate Controls detect and do not segregate or prevent defecƟve product X Control will provide indicator (visual or auditory alarm) of failure aŌer occurrence, but will not segregate defecƟve product 5 Moderately High Controls detect and segregate defecƟve product, but do not prevent X Control will provide indicator (visual or auditory alarm) of failure aŌer occurrence and segregate defecƟve product 4 High Controls detect imminent failure X Control will provide indicator of imminent failure with a visual or auditory alarm 3 Very High Controls prevent and inform operator of correcƟve acƟon X Control will detect cause, stop machine if immediate acƟon not taken, and provide operator with informaƟon to adjust/maintain machine to prevent failure 2 Almost Certain AutomaƟc feedback control and correcƟon X Control will detect cause and automaƟcally adjust machine to prevent failure 1 Based upon these agreed-upon ranking tables the team will then step through each process and determine if there is a possible failure mode and assign a severity, occurrence, and detection ranking.

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Applying lean six sigma in the pharmaceutical industry by Bikash Chatterjee


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