Shruti Bhat PhD, MBA, Lean Six Sigma Black Belt
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How Can Pharma and Biotech Companies Maintain Quality While Rapidly Scaling Up Operations

10/15/2022

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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

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Categories: Lifesciences | Operational Excellence

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#operationalexcellence #qualitymanagementsystem #QMS  #pharmaquality  #riskbasedapproach
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Lean Manufacturing in Food, Drug, Cosmetics & Chemical Industry

2/25/2020

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Here is a case study that exemplifies ​improved productivity of pellet manufacturing by 28% per shift via LEAN. 
Learn about how to use LEAN Business Process Improvement methodology for
​Innovation and Manufacturing …
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

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Keywords and Tags:

​#Manufacturing #Lean #ContinuousImprovement #Kaizen  #QualityImprovement  #ManufacturingManagement  #Pharmaceutical  #LifeSciences  #Food  #Beverage  #Biotechnology  #LeanManagement 
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How to do speedy manufacturing site change for bio-pharma products? A Kanban and Kaizen Case Study

11/20/2019

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how to speedy manufacturing site change for bio_pharma products_ a Kanban and Kaizen case study
​Kanban and Kaizen Case Study

Problem: A multi-national bio-pharma company wanted to do a manufacturing site change for 55 products within an aggressive time frame of 5 months? Can this be done ? How ?

Due Diligence:  A due diligence of proposed manufacturing site was done and gap analysis report was documented. The due diligence report, gap- block strategy recommendations as well as budget estimations were provided to the organization’s executive management team; to facilitate Go/Kill decisions.

Solution: Kanban and Kaizen methodologies were employed. Product wise site-transfer protocols were developed (especially taking into consideration the different product/ process complexities and challenges (both known and anticipated), production capability and market demands. A product wise ‘Risk Assessment and Mitigation’ protocol was developed.

Result Dashboard:
  • All 55 products were transferred to new site as planned and within time & cost budget.
Note: The product development strategy is very important. Product made ‘glocal’ i.e. global appeal with local compliance and developed using QbD, exhibit very little issues while expanding to newer manufacturing sites.
​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

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​Keywords and Tags:
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Kaizen For Productivity Improvement Of Pellet Manufacturing: A Case Study

10/23/2019

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Learn how implementing Kaizen improved productivity of pellet manufacturing by 28%. For details checkout the video below-
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

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Kaizen Training for R&D, Manufacturing and Service-based Organizations

5/2/2019

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A Kaizen Transformation roadmap will help you balance two worlds- the 'right now' and the 'next future'.

Top Experts in Kaizen Strategy Design & Training 

Kaizen Masterclass workshop by Dr Shruti Bhat
Kaizen Masterclass
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Business Process Improvement for Manufacturing & Service Industry by Dr. Shruti Bhat

4/25/2019

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Business Process Improvement for Manufacturing & Service Industry by Dr. Shruti Bhat book preview-

One of the first people to describe business processes was Adam Smith (1776) in his famous example of a pin factory. Since then business processes have evolved and better defined. ​
Business process improvement methodologies for manufacturing and service industry book by Dr Shruti Bhat
A business process defines the various activities involved in achieving a particular goal. Business processes briefly describe the chain of events that are involved in an activity or a group of activities. It is common to use a business process if the activities have an effect on current products or data and bring about production. 

 Types of business processes include- 
​
  • Management processes such as Corporate governance, Strategic management, planning and implementation.
  • Operational processes, which constitute the core business and create primary value stream. Typically, they include Procurement & sourcing, Manufacturing, Marketing, Sales and Customer service.
  • Supporting processes, which support the operational processes and include Finance & Accounting, Recruitment & Human Resources Management, Research and Technical support.

Some examples include invoicing, product shipping details, updating information, tracking orders, allocating budgets etc. Business processes used throughout organization, at any level, are outlined in order to improve organization in an effective and efficient way. There can be several inputs in a business process but there is always only one output or specific goal- that is to help business thrive.

Business processes are used practically in any organization and throughout an organization at any level. They are used in a variety of industries such as private, public sector, government, departments, hospitals, charities etc. Business processes are, typically outlined in order to improve an organization in an effective and efficient way.

Various computer software make it possible to create business processes on a computer, however simple business processes are just as effective when written with pen and paper. Some even find it better to jot down the processes on a piece of paper, or on several small ones, in order to kick start their creativity and thinking process. It is up to the professional (and/or organization) to decide whether a software or traditional method will work best for them. Business processes work best when there is input, support and ideas from various people that are involved in the organization (or department).

Key business processes are logically grouped related tasks and activities, independent of the organization’s structure, which utilize the resources of the organization to produce specific results. They possess measurable inputs & outputs, value addition and repeatable activity.

Tip- The effective management of key business process requires- Ownership & planning, performance metrics & control, process qualification, management and improvement methodology.

A business process always begins with a customer’s need and ends with a customer’s need fulfilment.

Customer needs change, technologies change, government policies change, competition changes and what used to be a high level of performance becomes a poor one and it’s time to replace the formerly good process with a new one- only every process cycle should have this capacity of identification, in-built in its charter.

As a practicing Business Transformation expert of many years, I am happy to mention here few case studies, nay success stories. Let me share three examples-

  1. A consumer goods manufacturing company redesigned its product deployment process, by means of which, it now manufactures goods and delivers them to its distribution center such that inventory uptake was reduced by 35%, while stock-out goods situation declined by 70%.
  2. A pharmaceutical company created a new product development process, which reduced time to market by 75%, development costs by 45% and increased productivity by 30%.
  3. An engineering goods manufacturing organization increased its product delivery targets by 350% and reduced its supply chain costs by up to 55%. Something to note in these is the simultaneous achievement of apparently incompatible goals for e.g. reducing inventory while also reducing out –of-stocks.

Traditional organizations view these as conflicting goals and trade off against another. While process managed organizations, recognize that such payoffs, are achieved by improving business processes and continually maintain their business process efficient. So how do we go about bringing on a process change?

Three main categories of business process improvement techniques, have been found to be extremely effective in managing, expanding and /or transforming businesses worldwide including USA, Canada, Latin America and the emerging economies. They are – Breakthrough improvement, Streamlined improvement and Continuous improvement. The 18 methodologies described in this book belong to one or many of these three main categories.

​
In this book, you will learn about: 
​
  • What is a business process? What are different types of business processes? Why improve a business process?
  • 18 different business process improvement methodologies including Lean, ISO, Kaizen, Six Sigma, Capability maturity model integration (CMMI) etc.
  • Advantages of each business improvement methodology. Precautions needed before implementing a methodology at your workplace.
  • Strategic planning and risk assessments involved prior to implementing a business process improvement methodology.
  • References of their use by startups, small companies who later on became big corporate houses and Fortune 500 companies.
  • Tips to maximize positive results from executing business process improvement methodologies for your organization.

This book presents a practical way to build and improve business processes, and assists professionals whether they are learning the basics of business process improvement, planning their first improvement project, or evangelizing process-oriented thinking throughout their organization.
Business process improvement methodologies for manufacturing and service industry book by Dr Shruti Bhat
​This book is for Agile entrepreneurs and business leaders involved in decision-making, directing their organization’s sustainability, profitability, and expansion. If you want some new ideas for improving your business and need to get your team involved, then this concise self-help, business management book is for you.

This book is also for professionals who are interested in making a career change and wish to embrace business process management (bpm) role.

This book is also for graduate students, budding out of colleges and are in the process of stepping into the industrial world- be it manufacturing or a service industry. This book helps them learn the various methods by which they can improve their company’s business, which in turn would help their career growths.
​
This book is for all ‘business book readers’ who wish to apply business improvement methodologies to their work place in most beneficial and practical ways.

​Grab your copy of this book NOW!
 
Available as paperback and digital versions at all popular stores worldwide!

About the author Shruti Bhat PhD, MBA, CLSSBB

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.

​

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Related reading:

  1. ​How to Choose a Business Process Improvement or Continuous Improvement project?
  2. Popular Continuous Improvement Workshops & Webinars for Manufacturing Industries
  3. Popular Workshops & Webinars on 'Continuous Improvement' for Service Industries
  4. Business Turnaround and Continuous Improvement Tips & Tricks Part 3 of 6- Agile in Nutshell for Improving Sales & Marketing of Products and Services
  5. Business Turnaround and Continuous Improvement Tips and Tricks- Part 2 of 6: Six Sigma in a Nutshell
  6. How to develop a culture of ‘Continuous Improvement’ in an organization?
  7. 8 Steps to becoming a Customer- centric organization
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​#DrShrutiBhat  #ContinuousImprovementAcademy  #Manufacturing #Lean #ProcessExcellence  #ContinuousImprovement #Kaizen  #QualityImprovement  #Innoworks  #Innovation  #Quality  #eLearning  #Business  #BusinessProcessManagement  #ServiceIndustry  #ManufacturingManagement  #LeanInnovation  #Pharmaceutical  #LifeScience  #Food  #Beverage  #Biotechnology  #Retail  #Cosmetics  #PersonalProducts  #Chemicals  #Drugs #Engineering #ShiftingParadigms #BPM  #LeanManagement  #KaizenLeaderMasterclass  #LeanSixSigma  #Kanban  #FMEA  #RiskManagement  #Speaker  #KaizenTrainingAcademy​
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Business Turnaround and Continuous Improvement Tips & Tricks Part 4 of 6- Lean Manifesto

2/22/2019

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​Born at Toyota, Lean is a lighter, leaner way to achieve results. A Lean process is ruthless about getting rid of errors, steps, processes and people that don’t add value to a company’s products or services.
business turnaround and continuous improvement tips and tricks part 4 of 6, LEAN Manifesto, dr shruti bhat
Lean is all about focusing on customer needs, reducing defects, creating waste-free processes that result in maximum ROI and Customer value.

Although Lean defined Toyota Production System (TPS) in 1940s, with time, Lean has been extended to other manufacturing verticals such as- electronics, cement, construction, food & beverages, pharmaceuticals, personal products, engineering etc. ​
The best part about Lean is that, Lean brings in a 3:1 rate of returns for any organization regardless of industry sector, that implements Lean correctly.
​Lean Manifesto:

  • Focus on customer: Lean is based on Voice of Customer (VOC). If a step doesn’t add value to a company’s product or service from the customer’s point of view, LEAN strips it out.
  • Eliminating waste: Traditional Lean weeded out 7 types of waste- Over-production, Over-processing, Defects, Delays, Unnecessary movement, Unutilized resources, Unnecessary inventory. With time, Lean philosophy has under gone changes too, that is changes for the better. Present day LEAN methodology eliminates 14 different types of waste.
  • Just-in-time (JIT) attitude. Producing anything in anticipation of customer needs is a waste as per Lean philosophy. Instead you produce only when there are orders in hand as in Kanban's pull approach.
  • LEAN works with ‘pull’ system Vs ‘push’ system.
  • Visual representation: Lean uses Value Stream Maps to visually draw out processes and Visual Management to execute and sustain benefits of LEAN processes.
Which companies can use Lean?

LEAN can be implemented by Manufacturing as well as Service based companies.

LEAN is best for incremental improvements, organizations that focus on their people and culture, companies that want a less mathematical and more flexible approach than Six Sigma. But you can strive for a break-through Six Sigma improvement by eliminating waste Lean-style.

​
In the next part of this article series I shall discuss another time-tested business improvement methodology;
TQM
​​

Related reading:

  1. Business Turnaround and Continuous Improvement Tips and Tricks Part 1 of 6
  2. Business Turnaround and Continuous Improvement Tips and Tricks- Part 2 of 6: Six Sigma in a Nutshell
  3. Business Turnaround and Continuous Improvement Tips & Tricks Part 3 of 6- Agile in Nutshell for Improving Sales & Marketing of Products and Services
  4. Business Turnaround and Continuous Improvement Tips & Tricks Part 5 of 6: TQM in a Nutshell
  5. Business Turnaround and Continuous Improvement Tips & Tricks Part 6 of 6 : Balanced Score Card
  6. ​Continuous Improvement for Human Resources (HR) department via Lean and Kaizen
  7. Lean Manufacturing in Food, Drug, Cosmetics & Chemical Industry

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​#Manufacturing #Lean #ContinuousImprovement #Kaizen  #QualityImprovement   #BusinessProcessManagement  #ServiceIndustry  #ManufacturingManagement   #LeanManagement #KaizenLeaderMasterclass #LeanSixSigma #LeanManifesto #LeanManufacturing
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