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www.sqaservices.com - "Global Quality on Demand"2nd International Summit onGMP, GCP & Quality Control
Leaning Towards Action II:
pursuing quality in healthcare manufacturing
Gerard J. PearceExecutive Vice President
SQA Services, Inc.
www.sqaservices.com - "Global Quality on Demand"2nd International Summit onGMP, GCP & Quality Control
2www.sqaservices.com - "Global Quality on Demand"
MHRA Warns Diabetics About Counterfeit Insulin Pen NeedlesCounterfeit batch of insulin pen needles found circulating in UK supply systemThe 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.
The Cost of Poor Quality
May 7, 200780 children die in Haiti due to contaminatedglycerin in acetaminophen syrup
www.sqaservices.com - "Global Quality on Demand"2nd International Summit onGMP, GCP & Quality Control www.sqaservices.com - "Global Quality on Demand"
The Cost of Poor Quality
www.sqaservices.com - "Global Quality on Demand"2nd International Summit onGMP, GCP & Quality Control
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”?
RISK
www.sqaservices.com - "Global Quality on Demand"2nd International Summit onGMP, GCP & Quality Control
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’
www.sqaservices.com - "Global Quality on Demand"2nd International Summit onGMP, GCP & Quality Control www.sqaservices.com - "Global Quality on Demand"
‘Just a few interested parties…
www.sqaservices.com - "Global Quality on Demand"2nd International Summit onGMP, GCP & Quality Control
www.sqaservices.com - "Global Quality on Demand"2nd International Summit onGMP, GCP & Quality Control
Documentation and Records
27%
Laboratory Controls16%
Buildings and Facilities 13%
Quality Management12%
Process Equipment 11%
Production and Process Controls
11%
Personnel and Training11%
Top 7 Findings
What we see…• Reasonable sample• Different interpretations,
but consistency• Consistent with industry
view• Other areas include:
– Validation– Materials Management– Change Control
www.sqaservices.com - "Global Quality on Demand"2nd International Summit onGMP, GCP & Quality Control www.sqaservices.com - "Global Quality on Demand"
GBP• Complex environment• Detailed requirements• Simple trigger• Action
www.sqaservices.com - "Global Quality on Demand"2nd International Summit onGMP, GCP & Quality Control
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
www.sqaservices.com - "Global Quality on Demand"2nd International Summit onGMP, GCP & Quality Control
Recap
• Challenges facing the organization• Primary issues and concerns• What we see• GBP• Conference focus• Action!
www.sqaservices.com - "Global Quality on Demand"2nd International Summit onGMP, GCP & Quality Control www.sqaservices.com - "Global Quality on Demand"
Questions and further information:
Gerard Pearce310-802-4448
THANK YOU!
