What

1
Whats New in the FDAs Pharmaceutical
Inspectorate and Risk Based Systems Inspection

• Rick Perlman
• Chair
• Food, Drug, and Cosmetic Division ASQ

2
Everything that can be invented has been
invented

• Charles H Duell
• Commissioner, US Office of Patents
• urging President McKinley to abolish his office
  in 1899

3
What is the Pharmaceutical Inspectorate

• FDA developed certification program
• High level Pharmaceutical Investigators
• Primarily used for complex processes or high risk
  drug products

4
History of the PI

• Certification started in 1994
• Resulted from Industry asking for a more
  consistent inspection activity
• Will continue as long as needed/funded

5
Purpose

• Training and development to maintain qualified
  staff
• Structured approach to obtain, maintain and apply
  competencies

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Objective

• Assurance that investigators have the skills and
  knowledge to perform their jobs

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Certification Areas

• Drugs
• Blood
• Seafood
• Medical Devices

8
Types of Drug Certification

• Level I
• Level II
• Level III

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Certification - Level I

• Mandatory
• New hire Investigators
• Training completed in first 12 months
• Demonstrate competency via audit of results

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Level I Training

• Web Based
• Classroom
• Basic Food and Drug Law
• Evidence Development
• Investigative Interviewing
• Quality Auditing

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Level I Audit Criteria

• Supervisor looks for
• General Investigative practices
• Evidence
• Ability to recognize, identify, and collect
  evidence to support findings
• Communication
• Verbal
• Written
• Professionalism

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Certification - Level II

• Not mandatory
• Requirements
• Minimum of 25 in Drugs
• Submit documentation to Level II Drug
  Certification Board
• Pass performance audit
• Recertify every 3 years (18 CEUs)

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Prerequisites - Level II

• Level I Certified
• Training
• Drug manufacturing and quality control
• Pre-Approval Inspections
• Industrial Sterilization (Drugs and Devices)
• Computer Systems Validation
• API manufacturing

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Certification Board - Level II

• National Expert
• Experienced Field Investigator
• Experts
• CDER
• CVM
• Field Manager
• DHRD Specialist

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Level II Audit Criteria

• Compliance Assessment
• Evidence
• Verbal Communication
• Professionalism

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Certification - Level III

• The Pharmaceutical Inspectorate
• Not Mandatory
• Planning for 50 members by FY 07

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Level III Eligibility

• Minimum 3 years inspecting Drug Firms
• Certified as Level II
• Must pass six system Audit
• Endorsed by District/Office Management
• Selected or nominated by Level III Certification
  Board

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Level III - How?

• Submit request to Supervisor
• Submit Certification Packet to Certification
  Board
• Concurrence from District Management
• Screened by Certification Board

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Level III Certification Board

• 2 Field Investigators (National Experts)
  operating at Level III
• 2 Experts
• CDER
• CVM
• DFI program Expert
• ORA Field Management
• DHRD

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Level III Candidates

• Mainly Investigators with experience and training
  in pharmaceutical manufacturing
• Report directly to ORA District Office
• Spend 80 of time in drug inspection, both
  Foreign and Domestic

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Level III - Expected Competencies

• Regulating Pharmaceutical Quality in relation to
  the FDAs mission
• Risk Management
• Advanced Quality Systems
• Pharmaceutical Science

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Level III - Expected Competencies

• Current Regulatory Programs/Procedures
• Technology
• Investigations

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Level III - Admission

• Packet successfully reviewed
• Pass
• Screening
• Training
• Participate in Center details
• Pass final evaluation

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Level III - When

• First course completed in 2005
• Second course 2006

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Level III - Courses

• Quality Systems
• Risk Assessment and Management
• Critical Thinking
• Quality by Design
• PAT

• Design of Experiments
• ICH Guidances
• Process Capability
• Technology Transfer
• CAPA

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Level III Expectations

• Continual learning to enhance their expertise
• Develop and implement formal training for
• FDA
• Industry
• State/Local Officials

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Level III Expectations

• Develop/Evaluate in their area of expertise
• Programs
• Policies
• Procedures in their area of expertise
• Auditors for Level II or Level III Drug
  Certification

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Risk Management

• ICH Q9
• Quality Risk Management
• Adopted November 9, 2005

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Risk

• Evaluated on
• Product, Process, Facility
• Controls
• Robustness of Quality System

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Risk

• Regulatory Oversight based on
• Applications
• Post Approval Changes
• GMP Inspections

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Risk - Desired State

• Barriers to continuous improvement are removed
• manufacturing
• product quality
• Meaningful Specifications
• Common understanding of risk
• Industry and Regulators on same page
• focused on highest risks
• understanding of residual risks

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Risk - ICH Q9

• Provides a guidance document for understanding
• Defines common terms
• Facilitates
• movement toward desired state
• communication
• movement from fire fighting to risk management

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Why ICH Q9

• To ensure a common understanding of Quality Risk
  Management by both industry and regulators

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What ICH Q9 Provides

• A common language and process
• Potential methodologies for Quality Risk
  Management
• Where Quality Risk Management can add value

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What ICH Q9 Provides

• Broad risk concepts and principles
• Principles for implementation
• Elements of the process
• Not a single tool but the right tool for the job
• Tools

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What ICH Q9 Is Not

• A cookbook for risk management
• Specifics for your situation
• Exhaustive treatment of theory
• A list of all potential methods

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FDAs Risk Based Inspections

• Matrixed Approach
• Based on
• product type
• potential harm
• population size

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Systems Based Inspection

• Six Systems
• Quality
• Materials
• Laboratory Controls
• Production
• Packaging and Labeling
• Facilities and Equipment

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Risk Based Inspection

• Depends on potential risk of your product/process
• Compliance History
• Inspection History
• Number of systems
• minimum of 2 (always Quality System)

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Thank You!
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Questions?