the history and future of the quality unit in...

The History and Future of the Quality Unit in Pharmaceutical Manufacturing:

ASQ/FDA Presentation by Chris AllenBayer Healthcare - June 23, 2005

The Quality Department is the cornerstone for our success.

QUALITY

We are facing rapid change in our industry.

How will these changes affect the quality unit?

Testing Lab

Quality Assurance

Design Controls

SamplingWet Chemistry

?

To help predict forward, we will take a brief look backward.

Then we will look at some current trends impacting our organization.

The organization of the quality unit has evolved over time.

Earliest industrial history was the artisan in the one-person shop.

Shop Master

Assistant Assistant Assistant Assistant Inspector

As shops grew, the job of a full-time “inspector” developed.

Director, Manufacrture

Factory Manager

Production Superintendent

Foreman Foreman Foreman Foreman

Worker Worker Worker Worker

Worker Worker Worker Worker

Worker Worker Worker Worker

Inspector Inspector Inspector Inspector

Inspector

Quality Departments supervised by Chief Inspectors formed in the 1920’s.

Director, Manufacrture

Factory Manager

Production Superintendent

Chief Inspector

ForemanInspection Foreman Inspectors

ForemanInspection Foreman Inspectors

ForemanInspection Foreman Inspectors

QUALITY DEPT.

Quality engineering and statistical quality control developed in the 1940’s.

Director, Manufacrture

Factory Manager

Quality Manager

ChiefInspector

Chief Inspector

Quality Control Engineering

Reliability engineering became popular in the 1950’s.

Director, Manufacrture

Marketing Manufacturing Quality

Quality Inspection

Reliability Engineering

Quality Control Engineering

Quality Assurance

The pharmaceutical GMP’s had a significant impact on the quality unit.

In the pharma industry, the quality approach was different.

Director, Manufacrture

Director of Quality

ManufacturingQuality Inspection

Quality Assurance

AnalyticalTesting Microbiology

Statistics

The quality unit has broad responsibilities defined in the regulation.

The organizational structure of the Quality Department is not mandated.

There has been little emphasis on quality science.

Director, Manufacrture

Director of Quality

Manufacturing Quality Inspection

Quality Assurance

Quality Control Engineering

Reliability Engineering

Statistics Dept

There are Pros and Cons of the Standard Pharma Quality Unit Design.

The organizational independence of the quality unit is a trade off.

Some current and future trends for quality organizations are evident.

Quality System Regulations

Process Analytical Technology (PAT)

100% Inspection Programs Design Space

Quality Science Quality Management Teams

The quality systems approach is under discussion.

Quality SystemsGuidance

QSR (Diagnostics)

ICH - Q10Initiative

Quality Management Teams (QMT) help build a quality culture.

Ensure all Departmentsare Working Together

Fully Integrates the Quality Department

with the rest of theplant

Excellent Forum for Developing and

Updating the QualityPlan

Comprised of GeneralManager and Staff

Meet Monthly

Review Quality Trends

Discuss Quality Problems

Select QualityImprovement Projects

LIMS systems become more powerful and integrated.

Electronic Laboratory Notebooks eliminate tedious manual entries.

PAT reduces manual testing.

Risk based management changes the way we think.

ICH - Q9

Product Quality ResearchInstitute - (PQRI)

Risk ManagementWork Group

FDA Guidance Documents

100% inspection programs improve our process knowledge.

Metal Check Devices

Automatic Weigh Check

Thickness Sorters

Vision Inspection Systems

Detectors: e.g. Caps, SealsEmpty Bottles

Will we be able to make the transition to the new quality paradigm?

The pharmaceutical industry is undergoing rapid change.

What will the Quality Unit of the Future Look Like?

More focus on Statistical Process Control and Reliability Engineering?More automation and less manual work (less chemists and more PCS Technicians?)Greater need for professional team facilitators, trainers, project managers?

Less need for lab spaceMore 100% InspectionGreater IT System

IntegrationApplication of Quality Science

How will these changes affect the quality unit?

Testing Lab

Quality Assurance

Design Controls

SamplingWet Chemistry

?

Quality Systems, Quality Teams, Risk

Management Concepts and New

Technologies Are Changing the Way

We Think and Work.

A QA unit that does not adapt to change will rapidly fall behind.

“If you want to get somewhere else, you must run at least twice as fast as that!”

Lewis Carrol

References:

Beall, D., “Quality Assurance and Internal Inspection” published in the FDA Handbookof Total Drug Quality – circa 1971.

Drew, J., “The Seven Deadly Sins of Quality Management” Quality Progress, 59-54,Sept. 2003.

FDA – 1978 Drug GMP’s and Preamble, Sept, 1978.

FDA, Guide to Inspections of Quality Systems, August 1999.

FDC Reports, The Gold Sheet, Vol. 39, No 4, April 2005.

Harbour, G.C. and Kieffer, R.G., “Quality Management Team (QMT) – Managing theQuality System”, Pharm. Technol. 24 (10), 152-158 (2000).

Juran, J. M. and Gryna, F. M., “Organizing for Quality” Quality Planning and Analysis,second edition, 1980, chapter 24.

“The Future of Standards” Quality Progress Magazine, July, 1999.

Wells, T. R., “The Benefits of Incorporating Quality Systems in the Drug GMPRegulation”, FDLI Update, Sept/Oct 2003.