Shruti Bhat PhD, MBA, Lean Six Sigma Black Belt
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Business Turnaround Of A Sick Contract Research Company- A Continuous Improvement Case Study

3/3/2020

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​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.

Watch on...
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#Manufacturing #Lean #ContinuousImprovement #Kaizen  #QualityImprovement  #ManufacturingManagement  #LeanInnovation  #Pharmaceutical  #LifeSciences  #Drugs #KaizenLeaderMasterclass  #Kanban  #ProductDevelopment #BusinessTurnaround  #BusinessTransformationofaCRO
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Lean Innovation, Hoshin Kanrii and Six Sigma (as DFSS) for Product Design, Development and Manufacture via 3D Printing; a Case Study

2/5/2020

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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-
​
  1. Application of Hoshin Kanrii and DFSS along with Quality-by-Design (QbD) to product development usually brings novelty in product features, process characteristics and/or product utility, thus favors patenting and generation of additional revenues.
  2. While, Lean Innovation creates products with effective and efficient production and packaging processes, with no scope for ‘rework’ thus, better Operations Management.

​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 …
To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

Recommended reading:​

  1. Workshops & Online Courses for Pharmaceutical Research and Drug Product Development by Dr. Shruti Bhat
  2. Kaizen for Cost-Savings and Organizational Excellence
  3. Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls?
  4. How to develop a culture of ‘Continuous Improvement’ in an organization?
  5. ​Innovation is not an initiative. It’s a business process !​
​Follow Shruti on Twitter, Facebook, YouTube, LinkedIn


​#ContinuousImprovement   #Innovation  #Lean  #HoshinKanri  #DFSS  #DesignForSixSigma
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Popular Workshops & Webinars on 'Continuous Improvement' for Research and Product Development

2/9/2019

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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

Some of the Popular Continuous Improvement Workshops & Webinars Conducted by Dr. Shruti Bhat to Increase R&D Efficiency -

Lean Innovation workshop by Dr Shruti Bhat
Mistake-proofing with FMEA and Poka Yoke, workshop by Dr Shruti Bhat
building capability and culture for innovation in your organization workshop by dr shruti bhat
design thinking masterclass by Dr Shruti Bhat
product development via quality by design workshop by Dr Shruti Bhat,
DFSS and Hoshin Kanrii for innovation and product development workshop by Dr Shruti Bhat
kaizen masterclass for manufacturing and service industries by shruti bhat
Continuous improvement tools for manufacturing and service industries workshop by Dr Shruti Bhat

    For brochures and other details Contact Us

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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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Workshops, Seminars & Online Course on Continuous Improvement by Dr. Shruti Bhat

11/6/2018

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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  
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Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls?

11/3/2018

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First Valsartan, now Irbesartan formulations are going thru a recall. As these product recalls are happening world-over, the chaos is enormous...
Mistake proofing pharmaceutical products_ what can we learn from valsartan losartan and irbesartan product recalls
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:

Mistake-Proofing Pharmaceutical Product Development, Manufacturing and Logistics, Cost Savings via Poka Yoke
Book on Kaizen for Pharmaceutical, Medical Device and Biotech Industries; released as Paperback and Digital editions!
Improved Productivity of Pellet Manufacturing: 28% rise in output per shift: Continuous Improvement Case Study
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
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Workshops & Online Courses for Pharmaceutical Research and Drug Product Development by Dr. Shruti Bhat

10/23/2018

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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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    New Book Released!

    kaizen for pharmaceutcials, medical devices and biotech industry book by Dr Shruti Bhat
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    Shruti Bhat
    PhD, MBA
    Certified Lean Six Sigma Black Belt

    ​Shruti is a ​Global Leader in Lean Innovation, Lean Manufacturing, Business Transformation and Continuous Improvement; Best-Selling Author and Speaker.

    Shruti is a Go-To Scientific Expert and Management Leader within Pharmaceutical, Health Care, Device Technology, Bio- Technology, Life Sciences, Retail industry  and affiliated verticals.

    Shruti is a true 
    Thought Leader, who has ​accomplishments, awards, books, patents and several publications in peer reviewed journals. ​
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