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Business Turnaround Of A Sick Contract Research Company- A Continuous Improvement Case Study3/3/2020
Practising 'Daily Kaizen' has brought about swift turnaround of the sick contract research organization (CRO). Learn how Japanese Kaizen principle was used to speed-up Generic Pharmaceutical Product Development in a contract research company in Asia.
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Lean Innovation, Hoshin Kanrii and Six Sigma (DFSS- design for six sigma) for product design, development and manufacture via 3D Printing (i.e. Additive Manufacturing) Case Study by Dr. Shruti Bhat, gives benefits of applying Hoshin Kanrii, DFSS and Lean Innovation techniques to a drug product design, development and manufacture via 3D Printing.
The study findings however can be extended to product development across other industry verticals. Some of the benefits of applying continuous improvement methodologies such as Lean, Hoshin Kanrii and Six Sigma to research and product development include-
The study uses Isosorbide dinitrate (ISDN) as model drug, although other drugs can also be used in this therapeutic platform. 2x3 Factorial Design of Experimentation (DOE) was used to design drug beads. The results were evaluated for regression analysis, Main and interaction effects of parameters, Contrast Column Dispersion effects, Normal Probability Plots, Pareto and Process Capability Analysis. The drug beads were further used as ‘starter’ seeds to develop MUPS (multi-unit particulate system) anti-angina ‘rate-programmed’ drug product. The pharmacokinetic- pharmacodynamic (PK-PD) modeling was done using Doebrinska- Welling equation. MUPS were developed using 3D Printing technology via a 12- Run Plackett Burman DOE. All hardware, software applications involved in the study were pre-validated. All qualifications i.e. Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for each experimental run was done as per USFDA guidelines. Data was analysed statistically using Paired ‘t’ test. Reliability Testing was conducted as per ICH current Good Clinical Practices (cGCP) guidelines. Product prototype and Reference listed drug (RLD) were compared for bioequivalence compliance. The prototype is ready for commercialization. This study also gives benefits of using 3D Printing technique for pharmaceuticals and how the technique can be applied to product development across other industry verticals! For details on how to apply Lean Innovation, Hoshin Kanrii and DFSS to product design, development and manufacture, watch the video …
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#ContinuousImprovement #Innovation #Lean #HoshinKanri #DFSS #DesignForSixSigma Popular Workshops & Webinars on 'Continuous Improvement' for Research and Product Development2/9/2019 Shorten Product Development Times, Error-Proof Products & Services, Build Quality-by-Design and Increase R&D Productivity with Lean, Kaizen, Six Sigma and Other Continuous Improvement Methodologies About Shruti Bhat PhD, MBA, Certified Lean Six Sigma Black Belt Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops. Follow Shruti on Twitter, Facebook, YouTube, LinkedIn #ContinuousImprovement #QualityImprovement #Innoworks #Innovation #eLearning #LeanInnovation #LeanManagement #KaizenLeaderMasterclass
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#ContinuousImprovement #Kaizen #Workshops #ServiceIndustry #ManufacturingManagement #LeanInnovation #Pharmaceutical #LifeSciences #Food #Beverage #Biotechnology #Retail #Cosmetics #PersonalProducts #Chemicals #Drugs #Engineering #BPM #LeanManagement #KaizenLeaderMasterclass #LeanSixSigma First Valsartan, now Irbesartan formulations are going thru a recall. As these product recalls are happening world-over, the chaos is enormous... For the affected patients, it is horrifying to learn that they have unsuspectingly consumed a medicine that contains a potential carcinogen. In addition they have now to deal with product shortages; a product they consume daily to keep their blood pressure in check! For pharma companies, this is a huge hit to their brand image as well as to their bottom-line. Even though Impurities in drugs and drug products are a part of manufacturing process, drug companies strive hard to keep them at minimal and within specifications; be it as per ICH, FDA or company's internal standards. So what happened in case of Valsartan, Irbesartan? Are compendial testing procedures adequate? How were these impurities missed? Several such questions arise... A root cause analysis will dig into reasons for the lapse, but prevention is better than cure … this is more so true for defective pharmaceutical products. Lesson learnt from *SARTAN mishaps is as a wakeup call ! Recalls will surely stop patients from taking defective batches of Valsartan, Irbesartan. But what about the damage already done to patients who have consumed these defective products? And what is it that we must do to prevent something similar from happening again; not only for *SARTANs but any other drug or drug product? Impurities in drug/drug products: How NOT to miss them? Pharma R&Ds follow rigorous procedures to keep impurities/ degradation products at minimal possible levels. Drugs and drug products are developed using high standards and elaborate regulated procedures, yet how were these impurities missed out? And what to do to NOT miss them? A thumb rule whenever a 'defect' occurs means, underlying 'processes' are faulty and must be revisited- improved or re-designed. Here's the starting point- Drug and drug products are developed using ICH Quality norms, QbD (Quality-by-Design), PAT (Process Analytical Techniques) and similar such sophisticated guidances which facilitate 'risk-assessment'. Based on *SARTAN scenario, a logical question that pops up is- Are these 'risk- assessment' tools good enough? Or is there an application failure? In the former case, guidance documents need overhaul, while the later, points to inadequate training (around appropriate implementation of these guidances). Secondly, the whole concept of 'Mistake-Proofing' pharmaceutical products must be revisited ... Impurities are consequence of drug/ drug product manufacturing process. Any potential carcinogenic impurity carry overs into medicinal products and patients is no doubt hazardous; but it doesn't end there. What about these carcinogenic impurities getting into effluent systems and perhaps into the environment? This puts a larger population at risk! Existing IPQC, QA monitoring norms are not good enough when we deal with complex small molecule drug candidates. All processes (technical and/or operational) leading to the products must be studied comprehensively, supervised, modified and improved 'Continuously' ... A comprehensive Continuous Improvement methodology such as Kaizen must be rooted into pharmaceutical company operations Thirdly, stronger risk-assessment and risk-control tools must be adopted during development and processing of pharmaceutical products. Additionally, multiple risk-assessment and risk-control tools must be employed as standard operating procedure. Besides CAPA, FMEA, QbD, ICH and compendial norms, a structured 'Mistake-Proofing' methodology such as Poka Yoke- a Japanese concept for 'Mistake-Proofing', must be adopted as an integral part of Drug Discovery and Drug Product Development programs. Poka Yoke based Mistake-Proofing must be customized by companies for their line of business and product mix. Practicing such 'Mistake-Proofing-by-Design' principle will imbue pharmaceutical products with quality to face any rainy day. It main rain tomorrow! You may also like:Follow Shruti on Twitter, Facebook, YouTube, LinkedIn #Manufacturing #Lean #ContinuousImprovement #Kaizen #QualityImprovement #Losartan #Valsartan #Irbesartan #USFDA #Quality #eLearning #ManufacturingManagement #Pharmaceutical #LifeSciences #LeanManagement #KaizenLeaderMasterclass #RiskManagement #Impurities About the Author: Shruti Bhat PhD, MBA
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops. Follow Shruti on Twitter, Facebook, YouTube, LinkedIn #Manufacturing #QualityImprovement #Innoworks #Innovation #Quality #eLearning #Innovation #Workshop #ManufacturingManagement #Pharmaceutical #LifeSciences #Biotechnology #Cosmetics #PersonalProducts #Chemicals #Drugs |
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