Transcript cGMP Compliance Trends: An Industry Perspective 2005

GMP Compliance Trends:
An Industry Perspective
Mitchell W. Manning
Priorities Limited
[email protected]
GMP Compliance Trends: An Industry Perspective
Presentation Context:
Current Compliance Issues for Pharmaceuticals and Devices
Presentation Sources:
-
FDA.gov
ASQ
ISPE
PDA
Internet
-
Wall Street Journal
Fortune
Harvard Business Review
Burrill & Company
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.
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
GMP Compliance Trends: An Industry Perspective
Trend One:
GMP Compliant Manufacturing by Design
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
Process Control and Capability Cycle
Development History
Begin with the End in Mind
1.
Compliant
2.
Capable
3.
Robust
4.
In Control
5.
Continuously Improving
Integrated Validation Master Plan
process
product
systems
Process Flow Document
Establish shared standards
and expectations
Technology Transfer
Qualification
Document with GMPs in Mind
1.
Clear
Validation process and product
2.
Concise
3.
Correct
4.
Complete
Execute, Monitor and Control
5.
Confident
Technical Evaluations process and product
Change Control process and product
Execute and monitor with
best business practices.
Quality (GMP) Evaluations quality systems
Change Control quality systems
Assess results against the
standards and practices.
Quality Management System
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
Burrill's Predictions for Biotech in 2006
http://www.bcbiotech.ca/BIO_Links/Issue4/In_the_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.
GMP Compliance Trends: An Industry Perspective
Trend Three:
Outsourcing Compliance Leadership
GMP Compliance Trends: An Industry Perspective
Trend Four:
Risk Management of Compliance
GMP Compliance Trends: An Industry Perspective
Trend Five:
Compliance through PAT
GMP Compliance Trends: An Industry Perspective
Trend Six:
Multiple Compliance Requirements
GMP Compliance Trends: An Industry Perspective
Trend Seven:
Going Global
GMP Compliance Trends: An Industry Perspective
Trend Eight:
Going High Tech
GMP Compliance Trends: An Industry Perspective
Trend Nine:
Risk Management of GMP Inspections
GMP Compliance Trends: An Industry Perspective
Trend Ten:
Over-committing and under-performing
GMP Compliance Trends: An Industry Perspective
Trend Eleven:
GMP Compliance to GMP Quality
GMP Compliance Trends: An Industry Perspective
Trend Twelve:
Risk Taking before Risk Management
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