Pharmaceutical Quality is NOT a Spectator Sport

Has our industry lost its way when it comes to product quality? Our quality units seem to be focusing on reviewing documents and assembling metrics. Most, if not all, of these activities focus on the rearview mirror, catching errors in batch records, investigating deviations, and monitoring how long it takes to get the deficiencies in the manufacturing process corrected so we can release product. What is wrong with this picture?

Have we forgotten that quality must be built into what we produce? We seem, as an industry, to have figured out how to maintain a safe working environment, probably learned from other industries, where we identify the risks inherent in our daily workplace, and either engineer them out or teach our workers how to avoid the danger. We also, in many cases, establish safety cultures that include regular safety audits and programs to remind everyone how to avoid risks. We then use one or two simple metrics to monitor and celebrate our success.

In pharmaceutical and biopharmaceutical manufacturing today, we seem to prioritize speed and cost control in the manufacturing supply chain, but don’t seem to understand that building in quality will contribute significantly to both metrics. Where, then, do we refocus our quality resources to have an impact on quality before and during production, where right the first time becomes the simple, most important metric of quality product?

1. Process design and validation – Quality units should be establishing a role to partner with scientists and engineers to ensure the process design is robust, well-tested, and proven capable through a strong validation exercise. This is accomplished by partnering in the development and execution, not limiting quality involvement to review and comment after the fact.

2. Effective Instructions – Regardless of title, batch record, work instruction, or checklist, whenever humans are involved, the ability to easily understand and follow what and how a task is accomplished must be provided and available during the manufacturing process.

3. Sufficient Education and Training – Providing dozens of standard operating procedures and asking someone to simply read and understand, coupled with a few days watching someone else perform a task, is a recipe our industry has followed for decades, and the consistently poor results are reflected in the unchanging regulatory deficiencies seen by our colleagues in the FDA and other regulatory bodies. People learn by doing, developing the mental and muscle memory of how to perform tasks and achieving consistent and sustainable performance when they couple that with understanding the “why” behind performing the task.

4. Ongoing Coaching and Positive Reinforcement – As organizations have chased cost controls, the role of supervision has evolved into one of administration of documentation, both in operating and quality units. The definition of supervision is “a critical watching and directing of activities or a course of action.” As an industry, we must allow supervisors and quality experts on the floor to fulfill this role. This, of course, means investing in these individuals so they have the expertise to properly coach and mentor operators.

If you agree with me that these four areas of focus are the true foundation for quality pharmaceutical and biopharmaceutical manufacturing, how do we start the transition?

I believe it must start with a cultural shift in leadership, from maintaining compliance to building quality into the process. Quality leaders must build both an organizational structure and skill level in their teams to proactively participate and lead in these four key quality elements. Quality, as we have done with safety, must be primarily a proactive, preventive effort with the retrospective activities like document review and deviation management relegated to a subordinate role supporting continuous improvement.

We must protect our patients in the same manner as we protect our workers. Quality is definitely not a spectator sport!

________________________________________________________________________

QxP Vice President Mike Levitt started his more than 30-year career in pharma leadership as Director of Production Operations at Eli Lilly and Company back in 1989.

Check out Mike’s other recent blogs: “Is it Time to Outsource Internal Auditing?” and “Six Keys for Effective Deviation Investigators.

Coaching and Correcting: A Focus on Behavior Over Blame

Sarah Boynton
November 1, 2023

The Importance of Roles and Responsibilities in Biotech Manufacturing & Human Error Prevention

Sarah Boynton
October 26, 2023

Remote cGMP Inspections and AI in Drug Manufacturing

Michelle Fishburne
October 11, 2023

4 Best Practices for Effective Investigation into Deviations

Sarah Boynton
September 19, 2023

The Art of Viral Vector Manufacturing: 4 Essential Controls to Prevent Cross-Contamination

Sarah Boynton
September 13, 2023

Practicing Risk Acceptance

Mark Roache
August 28, 2023

Annex 1 – Can we all take a deep breath now?

Vanessa Figueroa
August 24, 2023

In Cell and Gene, Good Science is Necessary, But Not Sufficient

Mark Roache
August 21, 2023

6 Ways To Achieve Manufacturing Audit And Inspection Readiness

Sarah Boynton
August 14, 2023

Experience is What You Get Just After You Needed It, Part 2

Mark Roache
August 10, 2023

Experience is What You Get Just After You Needed It, Part 1

Mark Roache
August 10, 2023

Sterility Assurance Matters to This ONE

Greg Gibb
August 8, 2023

Enhancing Quality and Safety: 3 Essential Human Error Prevention Tools for cGMP Manufacturing

Sarah Boynton
August 3, 2023

Asia-Pacific Happenings: Samsung Bioepis Implements QxP Virtuosi®

Michelle Fishburne
August 2, 2023

CDMOs – Selecting the Right One for Each Manufacturing Stage

Christine Feaster
July 24, 2023

3 Types of Human Error and Potential CAPAs to Prevent Them

Sarah Boynton
July 20, 2023

Drug Shortages: Causes & Solutions

Christine Feaster
July 10, 2023

The 5 Questions You Need to Ask After a Human Error Event Occurs

Sarah Boynton
July 5, 2023

Understanding How Adults Learn

Mike Levitt
June 30, 2023

Annex 1 and Ensuring Filling Technologies Fit the Need

Natasha Howard
June 21, 2023

How to Solve Pharma’s Skilled Workforce Deficit

Jeff Roy
June 20, 2023

ChatGPT Told Me AI is “Imperative” in Pharma Manufacturing

No items found.
June 18, 2023

Get Ready: FDORA’s Unannounced Foreign Inspection Pilot Program is On!

Crystal Mersh
June 6, 2023

Nitrosamines Impurity Challenges

Christine Feaster
June 2, 2023

All You Need to Know About Contamination Control Strategies, Parts 1 and 2

No items found.
June 1, 2023

When is ISO 8 Not ISO 8?

Bob Ferer
May 30, 2023

Cost Of Quality: Worth Every Cent In Bio/Pharmaceutical Manufacturing

Crystal Mersh
May 24, 2023

The Six Keys for Effective Deviation Investigators

Mike Levitt
May 18, 2023

There Has to be a Better Way to Train

Tyler DeWitt, Ph.D.
May 15, 2023

Cell and Gene: Article Series on CGT’s Key Drivers

Mark Roache
May 8, 2023

Bacterial Endotoxin Testing is on the Move

Christine Feaster
May 5, 2023

Top 20 Pharma Company Chooses QxP Virtuosi® Platform

Vanessa Figueroa
May 3, 2023

Crystal Clear: Controls Are Not Enough

Crystal Mersh
April 22, 2023

Myth #1: Complying with Regulations and Product Specifications

Brian Duncan
April 20, 2023

Myth #2: Proactively Remediating Bad Inspection Outcomes: What’s the benefit?

Brian Duncan
April 20, 2023

Is it Time to Outsource Internal Auditing?

Mike Levitt
April 18, 2023

Quality is Number One, Even When Trying to Address Supply Chain Issues

Christine Feaster
April 14, 2023

Don’t Be a Daredevil When Retrofitting Your Facility, Part 2

Bob Ferer
April 10, 2023

Don’t Be a Daredevil When Retrofitting Your Facility, Part 1

Bob Ferer
April 10, 2023