Pharmaceutical products were manufactured in 44 countries in 2019*. The production processes lend themselves to improvement through the use of Lean and Six Sigma methodologies. We’ll look at a general paper on implementing Lean and Six Sigma in the pharmaceutical industry and three case studies: one each from Ireland, India, and Indonesia. Then we’ll finish with a video on how pills are made. *Source


Lean and Six Sigma for the Pharmaceutical Industry


In a paper titled “Lean and Six Sigma Concepts – Application in Pharmaceutical Industry,” authors Katarina Pavlovi and Vojislav Božanić discuss the need for change in order to implement Lean and Sigma in the pharmaceutical industry.

The article includes a comparison of FDA Current Good Manufacturing Practices (cGMP) with Lean.

You can read the article here.


Applying Lean Six Sigma to Pharmaceutical Manufacturing: Ireland


In a case study titled “Applying Lean Six Sigma Methodology to a Pharmaceutical Manufacturing Facility: A Case Study,” authors Brian Byrne, Olivia McDermott, and John Noonan discuss the use of integrated Lean Six Sigma to reduce downtime within a pharmaceutical manufacturing site while not affecting the production required to meet demand coupled with an increase in product quality.

The case study includes:

  • Seven Step Problem Solving Tools
  • Current Value Stream Map
  • Bar Graphs of Packaging Downtime Issues and Losses
  • Short Stops Across Nine Packaging Lines
  • Incidences of Blister Lines Short Stops
  • Stoppage Breakdown by Shift
  • Process Steps, Work Performed, and Average Time Taken
  • Table Feed Blockage
  • Downtime by Table Lot
  • Pareto Chart of Tablet Breakage Occurrences
  • Table Feed 5 Whys
  • Key Corrective and Preventative Actions
  • Future Value Stream Map

Click on the following link to open the case study.


Using Lean Six Sigma to Reduce Changeover Time: India


In a case study titled “A case study on Lean Six Sigma for a reduction in changeover time of dry granulation area in leading pharmaceutical company,” authors Mohd Ahsan Khan, Priyadarshan Pachorkar, and Zeba Khan discuss the use of Lean Six Sigma to attack the problem of high changeover time in the dry granulation process antibiotic tablets in a roll compactor machine.

The case study includes:

  • Project Charter
  • Flow Diagram of Changeover of Roll Compactor
  • Opportunities Needed to Be Identified and Implemented
  • Changeover Time Reduction in Cleaning of Dry Granulation Area Equipment
  • Fishbone Diagram for Reduction in Changeover Time
  • Setup Activities as Internal and External
  • Conversion of Internal Activities to External Activities

The initial target was a 20% reduction in changeover time. The project led to a 43% reduction.

You can access the case study here.


Lean Manufacturing Applied to Improvement of Black Cough Medicine Production: Indonesia


In a case study titled “The Application of Lean Manufacturing for Operation Improvement: A Case Study of Black Cough Medicine Production in Indonesia,” authors Pramadona and Akbar Adhiutama discuss the application of Lean Manufacturing in Black Cough Medicine Production.

The case study includes:

  • Current Value Stream Map
  • Waste Discussions Result
  • Processing Times: Current and Future
  • Information Flow
  • Future Value Stream Map

You can read the case study here.


How Pills Are Made


Watch this video from How It’s Made on how pills are manufactured.

You can see the video here.



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