GMP Compliance Trends: An Industry Perspective

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GMP Compliance Trends An Industry Perspective

• Mitchell W. Manning
• Priorities Limited
• manningmitch_at_aol.com

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GMP Compliance Trends An Industry Perspective

• Presentation Context
• Current Compliance Issues for Pharmaceuticals and
  Devices
• Presentation Sources
• FDA.gov - Wall Street Journal
• ASQ - Fortune
• ISPE - Harvard Business Review
• PDA - Burrill Company
• Internet - Interviews

Presentation Disclaimer The information and
opinions expressed by the presenter are intended
for general training and educational use of the
conference audience and are not intended as
official positions of the ASQ/FDC-FDA.
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GMP Compliance Trends An Industry Perspective

• Trend One GMP Compliant Manufacturing by Design
• Trend Two Partnering With the Regulators
• Trend Three Outsourcing Compliance Leadership
• Trend Four Risk Management of Compliance
• Trend Five Compliance through PAT
• Trend Six Multiple Compliance Requirements
• Trend Seven Going Global
• Trend Eight Going High Tech
• Trend Nine Risk Management of GMP Inspections
• Trend Ten Over-committing and under-performing
• Trend Eleven GMP Compliance to GMP Quality
• Trend Twelve Risk Taking before Risk Management
• Trend Thirteen Rx GMPs preferred over Dx GMPs

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GMP Compliance Trends An Industry Perspective

• Trend One
• GMP Compliant Manufacturing by Design

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Integrated Quality System
Continuous Improvement
Design
Execute
Monitor/Control
Design determine what is really
important Execute translate into
manufacturing Monitor/Control translate into
quality assurance
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Process Control and Capability Cycle
Development History
Integrated Validation Master Plan process product
systems

• Begin with the End in Mind
• Compliant
• Capable
• Robust
• In Control
• Continuously Improving

Establish shared standards and expectations
Process Flow Document
Technology Transfer
Qualification

• Document with GMPs in Mind
• Clear
• Concise
• Correct
• Complete
• Confident

Execute and monitor with best business practices.
Validation process and product
Execute, Monitor and Control
Technical Evaluations process and product
Quality (GMP) Evaluations quality systems
Change Control process and product
Change Control quality systems
Assess results against the standards and
practices.
Quality Management System
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GMP Compliance Trends An Industry Perspective

• Trend Two Partnering with the Regulators
• Drug Pipeline
• Globalization
• Bioterrorism
• Counterfeit Drugs and Devices
• Pandemics
• GMP Complexity
• Personalized Medicine

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Burrill's Predictions for Biotech in
2006 http//www.bcbiotech.ca/BIO_Links/Issue4/In_t
he_Media/Burrill_12_22_05.asp Biotechnology
will continue to fuel a major transformation in
healthcare -- one that emphasizes earlier disease
detection, more targeted treatments, and
adjunctive support through enhanced nutrition. A
reasonably robust public equity IPO market -- 30
in the U.S. in 2006 and even a larger number
internationally. More pricing pressure --
managed care, CMS, various country health
ministries The trend towards Mergers and
Acquisitions will continue with substantially
more deals than 2005, especially among the larger
companies. Similarly, we will see more and
larger partnering deals with an emphasis towards
discovery stage deals. Drug safety issues will
be high on the agenda and approvals will be
tougher to obtain. The trend towards
personalized medicine will accelerate.
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GMP Compliance Trends An Industry Perspective

• Trend Three
• Outsourcing Compliance Leadership

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GMP Compliance Trends An Industry Perspective

• Trend Four
• Risk Management of Compliance

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GMP Compliance Trends An Industry Perspective

• Trend Five
• Compliance through PAT

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GMP Compliance Trends An Industry Perspective

• Trend Six
• Multiple Compliance Requirements

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GMP Compliance Trends An Industry Perspective

• Trend Seven
• Going Global

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GMP Compliance Trends An Industry Perspective

• Trend Eight
• Going High Tech

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GMP Compliance Trends An Industry Perspective

• Trend Nine
• Risk Management of GMP Inspections

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GMP Compliance Trends An Industry Perspective

• Trend Ten
• Over-committing and under-performing

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GMP Compliance Trends An Industry Perspective

• Trend Eleven
• GMP Compliance to GMP Quality

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GMP Compliance Trends An Industry Perspective

• Trend Twelve
• Risk Taking before Risk Management

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GMP Compliance Trends An Industry Perspective

• Trend Thirteen
• Rx GMPs preferred over Dx GMPs
• Globalization of Standards
• Coming together of Regulators and Industry
• Inspectorate Partnering
• Control Processes through Validation
• Skills Competency Validation
• Resolving Problems