FDA

1
FDAs Perspective on Industrys Compliance to
Voluntary Standards and Compliance Challenges
in 2000

• Steven A. Masiello, Director
• James S. Cohen, Deputy Director for Operations
• Office of Compliance and Biologics Quality
• Center for Biologics Evaluation and Research

2

• Historical Review of Enforcement Issues
• Current Compliance Issues
• Source Plasma Compliance Program
• Office of Compliance and Biologics Quality

3
Suspensions/RevocationsSource Plasma
QPP
4
RecallsSource Plasma
QPP
5
Total Recalls
6
Error/Accident ReportsSource Plasma
QPP
7
Total Error/Accident Reports
8
Warning LettersSource Plasma
QPP
9
Current Compliance Issues

• Non-existent or ineffective QA programs
• Qualifications/training of physician substitutes
• Inadequate procedures for Lookback
• Inadequate SOPs
• shared SOPs not adapted for user

10
Source Plasma Compliance Program

• Current program in place for several years
• Will be revised by end of FY99
• Redrafted similar to blood compliance program
• Focus on critical issues in plasmapheresis
  centers
• No change in inspectional frequency

11
Source Plasma Compliance Program(cont.)

• New Inspectional Issues
• Biologics License Application (BLA)
• Changes to an approved application
• Elimination of the title Responsible Head
• Saline dilution of samples for viral marker
  testing
• Year 2000 data change for computer systems

12
Office of Compliance and Biologics Quality
13
James S. CohenDeputy Director for
OperationsOffice of Compliance and Biologics
Quality

• Opportunity to meet
• Work with ABRA
• ensure product quality
• improve communications
• Critically review
• compliance activities
• approaches to working with industry