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

Out of Specification Impurity and Non-Compliance to Manufacturing Standards Continue to Haunt Pharmaceuticals- The Lupin Story.  Here's One Way to Correct the Mess ...

1/29/2019

0 Comments

 
Out of specification impurity continues to haunt pharmaceutical products. There is yet another USFDA report citing out of specification product impurity and inappropriate processing issues in a reputed pharma company!
out of specification impurity and non-compliance to manufacturing standards continue to haunt pharmaceuticals- the lupin story. Way to correct the mess
For the third time in four months, Lupin Pharmaceuticals has been admonished by the Food and Drug Administration for a series of troubling quality-control issues at a manufacturing facility.

In a recent inspection report dated January 25, 2019, the regulator cited the company for failing to thoroughly review unexplained deficiencies in batches of medicines and not taking ‘scientifically sound’ steps to evaluate samples.

Few other deficiencies include- OOS (out of specification) investigations not handled correctly, impurity levels in products exceed specification limits and detailed health hazard assessment for the presence of this impurity was not conducted as needed.

Further remarks include- failure to re-train analysts who were involved in the purported mis-identification of product impurity, CAPA (Corrective Actions Preventive Actions) not designed and implemented correctly, insufficient investigation of customer complaints.
​
Other observations include- Appropriate controls were not exercised over computers or related systems to assure that changes in master production and control records or other records are instructed only by authorized personnel; Equipment used in the manufacturing, processing, packaging or holding of drug products is not of appropriate design to facilitate operations for its intended use; Established lab control mechanisms are not documented at the time of performance, and a lack of oversight and training.

Related reading:

  1. Valsartan, Irbesartan, Losartan Product Recalls- What are the Lessons for Pharmaceutical Industry?
  2. Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls?
  3. Mistake-Proofing Pharmaceutical Product Development, Manufacturing and Logistics, Cost Savings via Poka Yoke​​​.
​A detailed root cause analysis shall of course open avenues of true ‘problem areas i.e. disjointed business processes’ which need correction, followed by a neat process improvement strategy and its flawless execution.​
Ideally, pharma companies must structure a dedicated Continuous Improvement lead and team within its organogram.
​There are over eighteen different continuous improvement methodologies to choose from.
Kaizen can be an excellent start to sort out this mess.​

How to Employ Kaizen in Pharmaceutical Operations?

Though a combination of nine types of Kaizen would be most suited; for starters, Gemba Kaizen can provide maximum help.

Gemba Kaizen is a method of continuous improvement that involves real time action. It is commonly used to add valuable activities to an organization, which help to add to the quality of customer satisfaction. When a problem arises, Gemba Kaizen pinpoints the issue as promptly as possible. The solution to the problem is then used to deal with the same problem, if it should reoccur, but ideally stops the problem from reoccurring in the first place. 
​
This method also implements ideas used in lean manufacturing, which help to reduce waste and unnecessary procedures.

One of the main goals of Gemba Kaizen is to eliminate anything that is not valuable, or adds value, to an organization, whether it is systems, procedures, employees, business verticals, machinery, facility and others. 

​Kaizen Case Studies:

  1. ​​Reduced Variations in Eye Drop Dosage; a Continuous Improvement Case Study: Kaizen in Pharmaceutical Product Development
  2. Kaizen Improved Patenting and Patent Filing Process ~ 20% drop in Patenting Cost; a Continuous Improvement Case Study
  3. How to Speed-up Pharmaceutical Generic Product Development?: Continuous Improvement Case Study
Follow Shruti on Twitter, Facebook, YouTube, LinkedIn
 
​
Keywords and Tags:
​#OOS #OutOfSpecification #ProcessExcellence  #ContinuousImprovement #QualityImprovement  #ManufacturingManagement  #Pharmaceutical  #LifeSciences    #Drugs  #RiskManagement  #Lupin
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