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