Keynote presentation for 2nd Annual GMP, GCP & Quality Control Summit.

1. Leaning Towards Action II:
pursuing quality in healthcare
manufacturing
Gerard J. Pearce
Executive Vice President
SQA Services, Inc.
2nd International Summit on
GMP, GCP & Quality Control
www.sqaservices.com - "Global Quality on Demand"

2. The Cost of Poor Quality
MHRA Warns Diabetics About
Counterfeit Insulin Pen Needles
Counterfeit batch of insulin pen needles found
circulating in UK supply system
The Medicines and Healthcare products Regulatory
Agency (MHRA) is today warning diabetics about a
counterfeit batch of insulin pen needles that are
circulating in the UK.
May 7, 2007
2nd International Summit on
GMP, GCP & Quality Control
80 children die in Haiti due to contaminated
2
glycerin inwww.sqaservices.com - "Global Quality on Demand"
acetaminophen syrup

3. The Cost of Poor Quality
2nd International Summit on
GMP, GCP & Quality Control
www.sqaservices.com - "Global Quality on Demand"

4. Primary issues
• Reduce the cost of quality
• Ensure “products consistently meet
applicable requirements and
specifications”
• Growth in outsourcing and complex supply
chains
“Type and extent of control to be exercised”?
2nd International Summit on
GMP, GCP & Quality Control
RISK
www.sqaservices.com - "Global Quality on Demand"

5. What‟s on your mind?
• Fast changes, slow industry
• Interpretation of standards
– Client-specific needs
– Controlling quality at contract
manufacturers
• Supply Chain globalization
• Other:
– Security
– Managing „end-of-cycle‟
2nd International Summit on
GMP, GCP & Quality Control
www.sqaservices.com - "Global Quality on Demand"

6. „Just a few interested parties…
2nd International Summit on
GMP, GCP & Quality Control
www.sqaservices.com - "Global Quality on Demand"

7. 2nd International Summit on
GMP, GCP & Quality Control
www.sqaservices.com - "Global Quality on Demand"

8. What we see…
• Reasonable sample
• Different interpretations, but
consistency
Production and
Process Controls
• Consistent with industry 11%
view
• Other areas include:
– Validation
– Materials Management
– Change Control
Top 7 Findings
Personnel and
Training
11%
Documentation and
Records
27%
Process Equipment
11%
Laboratory Controls
15%
Quality
Management
12%
Buildings and
Facilities
13%
2nd International Summit on
GMP, GCP & Quality Control
www.sqaservices.com - "Global Quality on Demand"

9. •
•
•
•
Complex environment
Detailed requirements
Simple trigger
Action
GBP
2nd International Summit on
GMP, GCP & Quality Control
www.sqaservices.com - "Global Quality on Demand"

10. Conference focus
• Current standards/regulations
• How to apply them (and optimize
application)
• How to overcome challenges with them
• How to communicate/project them
• How to anticipate what‟s next
…and bringing out your inner rock star
2nd International Summit on
GMP, GCP & Quality Control
www.sqaservices.com - "Global Quality on Demand"

11. Recap
•
•
•
•
•
•
Challenges facing the organization
Primary issues and concerns
What we see
GBP
Conference focus
Action!
2nd International Summit on
GMP, GCP & Quality Control
www.sqaservices.com - "Global Quality on Demand"

12. THANK YOU!
Questions and further information:
Gerard Pearce
310-802-4448
gpearce@sqaservices.com
2nd International Summit on
GMP, GCP & Quality Control
www.sqaservices.com - "Global Quality on Demand"