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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 l.jpg

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 l.jpg
The BLA - Pre-Approval Inspections - Take Home Messages

  • 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


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The Pre-Approval Inspection - Purpose: - Take Home Messages

  • 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


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The Pre-Approval Inspection team - Take Home Messages

  • - “Biologics Team Inspection”

    • Headquarters and ORA


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Biennial inspections -Team Biologics - Take Home Messages

  • 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.


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Biennial inspections - Purpose - Take Home Messages

  • Assess ongoing compliance with the laws and regulations - cGMPs

  • Ongoing consistency of manufacturing

  • Current big issues:

    • Laboratories,

    • Stability

    • Adequate Investigations into problems.


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Biennial inspections Inspection Team: - Take Home Messages

  • Core team member

  • Product experts - CBER


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And how are these the same: - Take Home Messages

  • GMPs

  • Expectation of the highest quality manufacturing practices for the highest quality product

  • Inspections will be longer


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New Initiatives to be looking for: - Take Home Messages

  • Pre-announced inspections - all inspections

  • Annotated FDA-493s

  • Post Inspection Notification


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