Shruti Bhat PhD, MBA, Operations Excellence Expert
  • Home
  • About Shruti
  • Books
  • Insights
  • Operational Excellence
  • Research
    • Innovation Management
    • Leading Research and Development
    • Developer's Diary
  • Case Studies
  • Tools
    • Whitepapers
    • Articles >
      • Business Transformation
      • Process Improvement
      • Business Continuity
      • Change Management
      • Digital Transformation
      • Quality Improvement
    • Checklists and Templates
    • Free eBook
    • Videos
  • Blog
  • Engage Shruti
    • Consulting >
      • Operational Excellence Consulting
      • Business Transformation Consulting
      • Innovation Management Consulting
    • Workshops
  • Contact

How Can Pharma and Biotech Companies Maintain Quality While Rapidly Scaling Up Operations

10/15/2022

0 Comments

 
Picture
One of the biggest challenges facing pharma and biotech companies is scaling-up production and maintaining high quality standards. This is difficult for a variety of reasons. Fortunately, there are a number of ways to scaleup without compromising quality. Here are some ideas to consider: Outsourced development and manufacturing services, Technology transfer, Effective batch control, and Record-keeping.
 
Outsourced development and manufacturing services
 
Outsourced development and manufacturing services are an increasingly attractive option for biopharmaceutical companies. Pharma-biotech companies are often constrained by budgets or lack of resources, and outsourcing offers a flexible and scalable solution. Outsourced services can help pharma-biotech companies scaleup operations and maintain quality. Pharma-biotech companies typically evaluate three to six molecules during the early stages of product development, and they should look to outsource at this stage of their development. (Full disclosure- I am not canvassing for any CRO-CDMO).
 
Technology transfer
 
Technology transfer is a critical part of the production process for pharma-biotech. This process requires careful planning to ensure that quality remains high throughout the entire process. The transfer process must cover all aspects of process development, from analytical testing to packaging. In addition, the process should be transparent and cover all the bases, so that there are no unexpected occurrences or issues.
 
Relevant tech-transfer processes and effective talent management of people doing those tech-transfers assumes significance. I’ve a separate post on ‘Best practices for talent management in pharma companies’, you may check it out here.
 
Record-keeping
 
As pharmaceutical and biotech manufacturers scaleup their operations and seek to gain a competitive advantage, record-keeping is increasingly important.
 
Record-keeping helps ensure that processes and data are accurate and consistent. It also enables companies to achieve greater productivity, leading to lower production costs through economies of scale. This improves the bottom line and gives a company a competitive edge. However, pharma- biotech companies are also required to adhere to stringent regulatory requirements and safeguard the integrity of data.
 
Digitalization is a promising solution for efficient and effective record-keeping. Having said that, digitalization involves cost and not all companies may have extra funds to spend on it right away. If that’s the case, I would say- Companies can continue to use non-digital means for record-keeping while making sure to implement continuous improvement tools such as Kaizen, to keep their processes relevant.
 
Effective batch control
 
In order to ensure the quality of their products, pharma and biotech companies must make use of more data-driven and agile manufacturing methods. Currently, most data are stored in paper binders or siloed applications, which are not easily consumable by operators. This leads to a high risk of human error and a significant amount of overhead.
 
Installing suitable error-proofing measures to processes can nullify such issues. To know more check out: Mistake-Proofing Pharmaceutical Product Development, Manufacturing and Logistics, Cost Savings via Poka Yoke 
 
Risk-based approach to product development
 
Using a risk-based approach for product development, pharma-biotech companies can help avoid costly delays. Managing risk effectively is a key component of the drug development process, but it is often neglected. A comprehensive risk management plan based on ICH Q9 can help minimize overall risks and ultimately result in a more efficient development process and higher-quality product.
 
Single-use equipment
 
Single-use equipment can provide several benefits to pharma and biotech manufacturing. It eliminates the need for cross-contamination in the production process. Single-use solutions also provide greater mechanical resistance against impacts and tearing.
 
Overall, based on my first-hand experiences with pharma-biotech manufacturing processes, I would say that- “It is all in your setup and strategy around product manufacturing. They must focus upon three prime areas- (1) A robust quality system. (2) A thorough understanding of your quality data and (3) An engaged quality aspiring work culture. And these three elements cannot be implemented in retrospect.
 
If you need to scale-up and do not have a handle on these three elements, then I shall suggest, please stop, and re-evaluate your scaleup strategy. Because, not having a state of control over systems and processes and yet moving on with scaleup activities, will end up in gawky quality gaps and bigtime materialization of risks and losses. 

Related Reading:​
  1. Kaizen for pharmaceutical, medical device and biotech industries
  2. How to cut costs strategically using Kaizen
  3. Streamline processes and workflows with Gemba Walk.
  4. Top Ten Strategic Decision-Making Tools for Operational Excellence

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn

Categories: Lifesciences | Operational Excellence

Keywords and Tags:
#operationalexcellence #qualitymanagementsystem #QMS  #pharmaquality  #riskbasedapproach
Get In Touch
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
    To contact Dr. Shruti Bhat text or WhatsApp at 1.403.969.6219

    New Book Released!

    Revolutionizing Industries with Lean Six Sigma

    Shruti's YouTube Channel ...

    Picture

    Blog Categories

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

    Shruti's books...

    Picture
    top ten strategic decision-making tools for operational excellence
    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
    how to lead a successful business transformation
    leading organizations through crisis
    emotional intelligence
    how to overcome challenges of creating effective teams
    modular kaizen Vs Blitz kaizen
    How to increase employee engagement as a new boss

Connect with Dr. Shruti Bhat at- ​Twitter, YouTube, LinkedIn​

© Copyright 1992- 2025 Dr. Shruti Bhat ALL RIGHTS RESERVED.
See Terms and Conditions for details on this site usage.
Subscribe to Operational Excellence Academy YouTube Channel
​Subscribe to Operational Excellence Academy YouTube Channel
SHRUTI BHAT, CONTACT
Click to connect.
Created by Macro2Micro Media