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The complete GMPKit library — every insight on execution stability, COPQ reduction, and LEAN-led operational recovery.
12 posts
What Is the Cost of Poor Quality in Pharmaceutical Manufacturing?
March 10, 2026 • By Paul Van Buskirk
Cost of Poor Quality (COPQ) represents the hidden financial losses created when pharmaceutical manufacturing systems fail to execute consistently. While many sites track deviations, investigations, and batch failures, few translate those operational issues into financial impact. In many pharmaceutical organizations, COPQ quietly represents 25–40% of operational cost. Understanding where those losses originate is the first step toward restoring execution stability and recovering lost manufacturing capacity.
Dashboards Don’t Stop Debris
February 26, 2026 • By Paul Van Buskirk
Dashboards were never meant to be decorative. The original dashboard existed to stop debris before it reached the passenger. Modern business dashboards do the opposite — they measure the mess after it hits. In pharmaceutical manufacturing, that mess shows up as lost batches, deviation backlog, delayed disposition, and rework — the true drivers of Cost of Poor Quality. Visibility alone does not prevent failure. Structural correction does.
How to Calculate Your Facility's True COPQ (Free Calculator)
July 24, 2025 • By Mike Barlow, Paul Van Buskirk
Cost of Poor Quality (COPQ) can quietly erode margins in biopharma operations through rework, deviations, delays, and batch losses. This post breaks down the four key components of quality cost—prevention, appraisal, internal failure, and external failure—and introduces a free COPQ calculator to help you estimate the true financial impact and identify opportunities for ROI.
BatchTrak - Is it an Obeya Room?
July 12, 2025 • By Paul Van Buskirk
What is an Obeya Room? An Obeya room (from the Japanese word "Obeya" 大部屋, meaning "big room") is a centralized, physical or digital space used for collaborative project management and visual coordination, especially in Lean and Agile environments.
What Is Cell Therapy Manufacturing?
August 30, 2024 • By Mike Barlow
Cell therapy manufacturing involves several complex steps that require specialized training, equipment and strict quality assurance and control measures to ensure the safety, efficacy, and consistency of the final product.
How Does CAR-T Cell Therapy Work?
August 16, 2024 • By Mike Barlow, Paul Van Buskirk
In the world of medical advancements, few breakthroughs have captured as much attention and hope as CAR-T cell therapy. This innovative approach to cancer treatment holds the promise of revolutionizing the way we combat certain types of cancer. But how does CAR-T cell therapy work, and what makes it so remarkable? In this article, we'll delve into the intricacies of CAR-T cell therapy and explore how it harnesses the body's immune system to target and destroy cancer cells.
Cell Therapy vs. Gene Therapy: What’s the Difference?
July 12, 2024 • By Mike Barlow
In modern medicine, two powerful technologies—Cell Therapy and Gene Therapy—are reshaping how we treat serious diseases. Both aim to repair or replace what’s malfunctioning inside the body, but they take fundamentally different approaches.
How To Write the Perfect Problem Statement
May 29, 2024 • By Mike Barlow
If you work in Biopharmaceutical Manufacturing or Quality, one of the best things you can do to drive reliability in GMP Manufacturing is learn how to craft a strong problem statement. In this video, we will show you how to do that. Creating a strong problem statement is pivotal in problem-solving. A well-defined problem statement sets the stage for effective GMP deviation investigation and problem solving.
What is a GMP Deviation Investigation?
August 26, 2023 • By Mike Barlow
In GMP pharmaceutical production, including biologics and cell therapy manufacturing, a GMP Deviation Investigation is the structured process used to identify, document, analyze, and resolve any unexpected events or conditions that do not comply with approved procedures, specifications, or regulatory requirements.
Biologics Manufacturing Processing Steps
August 21, 2023 • By Mike Barlow, Paul Van Buskirk
Typical biologics manufacturing involves culturing cells in bioreactors (upstream processing) to produce the target protein, followed by harvesting to separate cells from the product-containing broth. The product is then purified through downstream processing methods like filtration and chromatography. Finally, it's formulated with stabilizers, filled into sterile containers, and undergoes quality testing before release.
What is Tangential Flow Filtration?
July 27, 2023 • By Mike Barlow
Tangential Flow Filtration (TFF), also known as Crossflow Filtration, is a widely used separation technique in biologics manufacturing for processes such as concentration, diafiltration, and buffer exchange of biomolecules like proteins, antibodies, and vaccines.
What are Biologics?
May 18, 2023 • By Mike Barlow
In biotechnology, biologics are therapeutic products made from living cells or organisms. Unlike chemically synthesized drugs, biologics are usually large, complex molecules such as proteins, cells, or genetic material.