The FDA Regulatory & Compliance Symposium
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Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
The FDA Regulatory & Compliance Symposium
Managing Risks – From Pipeline to Patient
August 24-26, 2005
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
cGMP Good for Business But Who is Enforcing Who?
Presented By: Anthony C. Celeste
Senior Vice President
Kendle/AAC
August 25, 2005
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Why GMPs?
• Historical Perspective
– Early concepts
– Development of GMP concept(s)
• Legislative Mandate 1962
– Regulation development
– June 1963
– 1968 “Intensified Drug Inspection Program”
– January 1971 Federal Register (Final Regulations)
– September 1978 umbrella cGMP Regulations
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N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Industry View of GMPs
– FDA Inconsistency
– Investigator expertise
– “Level the playing field”
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
GMP Benefits to Industry
– Good business practices
– Build in quality
• Enhance reputation
• Cut compliance costs
• Overall savings
• Avoidance of problems and bad publicity
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
FDA Enforcement Statistics
• Summary of FDA Actions/Activities
– 1999 - 2003
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Source of Data: Recall Operations Staff, Division of Compliance
Management and Operations, Office of Enforcement, HFC-210
Recalls = Products Recalled [Center Classification Determined by Product Type]Description
Description
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N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Description
Source of Data: Program Evaluation Branch, DPEM, Office of Resource Management, HFC-42Note: Does not include Office of Criminal Investigations data.
Description
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Source of Data: Program Evaluation Branch, DPEM, Office of Resource Management, HFC-42 Note: Does not include Office of Criminal Investigations data.
Description
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Source of Data: Division of Compliance Management and Operations, Office of Enforcement, HFC-210
Source of Data: Recall Operations Staff, Division of Compliance Management and Operations, Office of Enforcement, HFC-210
Description
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Source of Data: Recall Operations Staff, Division of Compliance Management and Operations, Office of Enforcement, HFC-210
Description
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
FDA Actions
– Significance of numbers?
– Risk Management
– Changing role of GMPs
– cGMPs for the 21st century
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Risk
• Probability of occurrence of harm and the severity of that harm
– Includes concepts of “hazard” and “exposure”
• What is the relevant “harm”?
– Unsafe or ineffective drugs
– Reduction in safety/effectiveness
• Clinically significant
– Reduction in drug quality
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Risk Management
• “Systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and controlling risk”
ISO 14971, Sections 2.13 and 2.18
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N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Risk Management
• Risk Assessment
– Relationship between process knowledge and process risk
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N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Risk Management
• Risk Control
– Option analysis
• Corrective and preventive actions
– Prioritize
– Implementation
– Residual risk evaluation
– Overall risk evaluation
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N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Risk Management
• Post-Production Information
– Post-production experience
– Review of risk management experience
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N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Risk Assessment
• An assessment of the product to determine:
– The probability of occurrence of harm from someone using your product
– The consequences of that harm and how severe it may be
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Risk Management
• Major Themes
– Focus cGMP requirements on public health risks
– Ensure FDA’s essential work does not impede innovation by industry
– Enhance the consistency and predictability of FDA’s approach
– Relevance of risk management to compliance activities
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N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Elements Impacting FDA Inspections
• cGMP Inspections
– Work planning (address risks)
– Investigator qualifications
• Communication of Findings
– Evaluate Warning Letters and FDA-483s
– Dispute Resolution
• Rollback of 21 CFR Part 11
• Encourage Best Practices
– Process Analytical Technology (PAT)
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N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
CDER Compliance Public Health Mission
• CDER has stated that its primary mission is ensuring that safe and effective drugs are available to the American public.
• CDER’s Office of Compliance advances CDER’s mission primarily by protecting Americans from unsafe or ineffective drugs.
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N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Pharmaceutical GMPs for the 21st Century
• February 20, 2003, FDA provided a progress report on various aspects of its GMP initiative, Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach.
– Integrating a risk-based approach applies to all aspects of the initiative, including various aspects of the GMP inspection programs.
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
What They Look At: Focus of FDA’s Inspection
• Revise compliance programs to implement risk-based targeting
– Focus inspection on areas most likely to uncover GMP deviations with greatest public health significance
– Statistically-based auditing for areas not known to be high risk
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
What They Look At: Focus of FDA’s Inspection
• Use risk assessment tools in evaluating significance of GMP deviations for further regulatory action
• Account for potential failures in a process – “Quality by Design”
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
CAPA
• “Corrective and Preventive Actions”
• One very effective way of managing risk
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Industry’s Role
• Participation with FDA
• Innovation and technical advances
• Quality management
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Participation with FDA
• Provide review, comment on guidelines and proposals
– Critical Path Initiative
– PAT
• Participate in committee deliberations (PDA, ISPE, Pharma, etc.)
• Training FDA Investigators/Reviewers
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N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Innovation and Technical Advances
• Share research and development initiatives in manufacturing
• Work with FDA on technical improvements
• Process Analytical Technology
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Quality Management
• Who is management?
• Results of poor management
• Proactive system(s)
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N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Who is Management
• Level in organization that is responsible for:
– Hiring and firing, especially in quality area
– Organize and respond to audit and inspection findings
– Control availability of resources dollars and personnel.
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N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Management Responsibilities
• Assure employee training and understanding
• Implement and document corrective actions
• Assure proper communications and decision making
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N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Results of Poor Management
• Lack of adequately qualified and well trained employees
• Poor quality systems in place
• Non-conforming manufactured products (GMPs)
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Penalties for Non-Compliance• FDA action
• Company’s reputation
• Effect on business
Real people. Real results.®
N o r t h A m e r I c a • E u r o p e • A s I a / P a c I f I c • L a t I n A m e r I c a • A f r I c a
Lessons Learned
• Those who cannot remember the past are doomed to repeat it.
• But the real challenge is quantifying the past for commitment to memory.
• If some is GOOD – more is BETTER.
Real people. Real results.®
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