Shruti Bhat PhD, MBA, Lean Six Sigma Black Belt
  • Home
  • About Shruti
  • Consulting
  • Workshops
  • Patents
  • Articles
    • Case Studies
    • Innovation Portfolio Development & Patents
    • Drugs-in-the- making
    • Culture Change & Business Transformation
    • Operational Excellence, Quality & Continuous Improvement
  • Books
  • Digital
  • Blog
  • Videos
  • Contact

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

11/3/2018

0 Comments

 
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
0 Comments

Your comment will be posted after it is approved.


Leave a Reply.

    Shruti Bhat, global leader in business turnaround, operational excellence and continuous improvement

    New Book Released!

    top ten strategic decision-making tools for operational excellence

    Shruti's YouTube Channel ...

    Picture

    Blog Categories

    All
    3D Printing
    5S
    Agile
    Artificial Intelligence
    Automation
    Balanced Score Card
    Biotechnology
    Books
    Business Turnaround
    Case Studies
    Change Management
    Chemical Industry
    CMMI
    Continuous Improvement
    Design Thinking
    Digitalization
    Drug Delivery
    External News Links
    Food Industry
    Hall Of Fame
    Healthcare
    Hoshin Kanri
    HR Development
    Innovation
    ISO
    Just In Time
    Kaizen
    Leadership
    LEAN
    Lean Six Sigma
    Life Sciences
    Machine Learning
    Manufacturing
    Medical Devices
    Mistake Proofing
    Motivational Cards
    Nanotechnology
    Operations
    Packaging
    Patents
    Personal Products
    Process Improvement
    Product Development
    Productivity Increase
    QbD
    Quality Management
    Robotics
    Scrum
    Service Industry
    Six Sigma
    Strategy
    Supply Chain Logistics
    Telecom Industry
    TQM
    Videos
    Voice Of Customer
    Workshops

    Shruti's books...

    Picture
    shruti bhat, business process management, continuous improvement
    kaizen for pharmaceutcials, medical devices and biotech industry book by Dr Shruti Bhat
    Book on Continuous improvement tools by Dr Shruti Bhat
    kaizen for leaders, continuous process improvement tool to increase profit and organizational excellence by shruti bhat
    kaizen, shruti bhat, continuous improvement, quality, operations management
    Picture
    how to overcome challenges of creating effective teams
    how to lead a successful business transformation

    ​Micro-Learning
    ​Partner

    Picture

    Publishing Partner

    fast read books, business management books, health and wellness books, spiritual guidance books, best online book store

    Wellness
    ​Partner

    Picture
© Copyright 1992- 2022 Dr. Shruti Bhat ALL RIGHTS RESERVED.
See Terms and Conditions for details on this site usage.
SHRUTI BHAT, CONTACT
Click to connect.
Created by Macro2Micro Media