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IMPACT OF the BLA and TEAM BIOLOGICS ON THE BIOTECH INDUSTRY - Take Home Messages. Julia Lukas Gorman OCBQ-DMPQ FDA-CBER. The BLA - Pre-Approval Inspections . Application format is well received Pre-Approval Inspections - longer and broader large part of the review decision process

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impact of the bla and team biologics on the biotech industry take home messages

IMPACT OF the BLA and TEAM BIOLOGICS ON THE BIOTECH INDUSTRY - Take Home Messages

Julia Lukas Gorman

OCBQ-DMPQ

FDA-CBER

the bla pre approval inspections
The BLA - Pre-Approval Inspections
  • Application format is well received
  • Pre-Approval Inspections -
    • longer and broader
    • large part of the review decision process
  • Firms have to be ready
  • Pre-approval compliance-handled in conjunction with the BLA review
the pre approval inspection purpose
The Pre-Approval Inspection - Purpose:
  • Assess capability to consistently produce product that meets the expected standards:
    • safe, pure and potent
    • consistent with the product used in the clinical trials
    • compliance with law and regualtions
the pre approval inspection team
The Pre-Approval Inspection team
  • - “Biologics Team Inspection”
    • Headquarters and ORA
biennial inspections team biologics
Biennial inspections -Team Biologics
  • Joint CBER-ORA initiative - system is in place and working
    • Role-out complete for all products - Oct 1999
  • Core team: Cadre of field inspectors with specialized training
  • Inspection style will be consistent with standard ORA practices
  • Compliance decisions will be made jointly - ORA/CBER.
biennial inspections purpose
Biennial inspections - Purpose
  • Assess ongoing compliance with the laws and regulations - cGMPs
  • Ongoing consistency of manufacturing
  • Current big issues:
    • Laboratories,
    • Stability
    • Adequate Investigations into problems.
biennial inspections inspection team
Biennial inspections Inspection Team:
  • Core team member
  • Product experts - CBER
and how are these the same
And how are these the same:
  • GMPs
  • Expectation of the highest quality manufacturing practices for the highest quality product
  • Inspections will be longer
new initiatives to be looking for
New Initiatives to be looking for:
  • Pre-announced inspections - all inspections
  • Annotated FDA-493s
  • Post Inspection Notification