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

Rick Perlman Chair Food, Drug, and Cosmetic Division ASQ

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

What is the Pharmaceutical Inspectorate

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

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

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

Objective

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

Certification Areas
Drugs Blood Seafood Medical Devices

Types of Drug Certification

Level I

Level II
Level III

Certification - Level I
Mandatory New hire Investigators Training completed in first 12 months Demonstrate competency via audit of results

Level I Training
Web Based Classroom
Basic Food and Drug Law Evidence Development Investigative Interviewing Quality Auditing

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

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)

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

Certification Board - Level II

National Expert Experienced Field Investigator Experts
CDER CVM

Field Manager DHRD Specialist

Level II Audit Criteria

Compliance Assessment Evidence Verbal Communication Professionalism

Certification - Level III

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

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

Level III - How?

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

Level III Certification Board

2 Field Investigators (National Experts) operating at Level III 2 Experts
CDER CVM

DFI program Expert ORA Field Management DHRD

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

Level III - Expected Competencies

Regulating Pharmaceutical Quality in relation to the FDAs mission Risk Management

Advanced Quality Systems

Pharmaceutical Science

Level III - Expected Competencies

Current Regulatory Programs/Procedures

Technology
Investigations

Level III - Admission

Packet successfully reviewed Pass:
Screening Training

Participate in Center details Pass final evaluation

Level III - When

First course completed in 2005

Second course 2006

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

Level III Expectations

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

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

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

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

Risk
Regulatory Oversight based on
Applications Post Approval Changes GMP Inspections

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

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

Why ICH Q9

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

What ICH Q9 Provides

A common language and process

Potential methodologies for Quality Risk Management Where Quality Risk Management can add value

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

What ICH Q9 Is Not

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

FDAs Risk Based Inspections

Matrixed Approach Based on
product type potential harm population size

Systems Based Inspection

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

Risk Based Inspection

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

Thank You!

Questions?