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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 . 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

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  1. IMPACT OF the BLA and TEAM BIOLOGICS ON THE BIOTECH INDUSTRY - Take Home Messages Julia Lukas Gorman OCBQ-DMPQ FDA-CBER

  2. 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

  3. 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

  4. The Pre-Approval Inspection team • - “Biologics Team Inspection” • Headquarters and ORA

  5. 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.

  6. 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.

  7. Biennial inspections Inspection Team: • Core team member • Product experts - CBER

  8. And how are these the same: • GMPs • Expectation of the highest quality manufacturing practices for the highest quality product • Inspections will be longer

  9. New Initiatives to be looking for: • Pre-announced inspections - all inspections • Annotated FDA-493s • Post Inspection Notification

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