Embed Size (px)
Citation preview
What’s New in the FDA’s 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 programHigh level Pharmaceutical InvestigatorsPrimarily used for complex processes or
high risk drug products
History of the PI
Certification started in 1994Resulted from Industry asking for a more
consistent inspection activityWill 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
DrugsBloodSeafoodMedical Devices
Types of Drug Certification
Level I
Level II
Level III
Certification - Level I
MandatoryNew hire InvestigatorsTraining completed in first 12 monthsDemonstrate competency via audit of
results
Level I Training
Web BasedClassroom
– 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 mandatoryRequirements
– 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 CertifiedTraining
– Drug manufacturing and quality control – Pre-Approval Inspections – Industrial Sterilization (Drugs and Devices)– Computer Systems Validation– API manufacturing
Certification Board - Level II
National ExpertExperienced Field InvestigatorExperts
– CDER– CVM
Field ManagerDHRD Specialist
Level II Audit Criteria
Compliance AssessmentEvidenceVerbal CommunicationProfessionalism
Certification - Level III
The Pharmaceutical InspectorateNot MandatoryPlanning for ~ 50 members by FY 07
Level III Eligibility
Minimum 3 years inspecting Drug FirmsCertified as Level II
– Must pass six system Audit
Endorsed by District/Office ManagementSelected or nominated by Level III
Certification Board
Level III - How?
Submit request to SupervisorSubmit Certification Packet to Certification
BoardConcurrence from District ManagementScreened by Certification Board
Level III Certification Board
2 Field Investigators (National Experts) operating at Level III
2 Experts– CDER– CVM
DFI program ExpertORA Field ManagementDHRD
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 FDA’s mission
Risk Management
Advanced Quality Systems
Pharmaceutical Science
Level III - Expected Competencies
Current Regulatory Programs/Procedures
Technology
Investigations
Level III - Admission
Packet successfully reviewedPass:
– Screening– Training
Participate in Center detailsPass 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 SpecificationsCommon understanding of riskIndustry and Regulators on same page
– focused on highest risks– understanding of residual risks
Risk - ICH Q9
Provides a guidance document for understanding
Defines common termsFacilitates
– 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 principlesPrinciples for implementationElements of the processNot a single tool but the right tool for the
jobTools
What ICH Q9 Is Not
A ‘cookbook’ for risk managementSpecifics for your situationExhaustive treatment of theoryA list of all potential methods
FDA’s Risk Based Inspections
Matrixed ApproachBased 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 HistoryInspection HistoryNumber of systems
– minimum of 2 (always Quality System)
Thank You!
Questions?
