Through the eyes of an inspector GMP Forum Melbourne 21 November - - PowerPoint PPT Presentation

through the eyes of an inspector
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Through the eyes of an inspector GMP Forum Melbourne 21 November - - PowerPoint PPT Presentation

Through the eyes of an inspector GMP Forum Melbourne 21 November 2019 Greg Orders Senior Inspector Overview The inspection process What happens at inspection Two case studies 2 GMP inspection process PRIOR TO THE INSPECTION


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SLIDE 1

Through the eyes of an inspector

GMP Forum Melbourne

21 November 2019 Greg Orders Senior Inspector

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SLIDE 2

Overview

  • The inspection process
  • What happens at inspection
  • Two case studies

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SLIDE 3

GMP inspection process

PRIOR TO THE INSPECTION

  • At least two weeks prior to the inspection you

will be contacted by the Lead inspector.

  • Site Master File requested and maybe other

documents.

  • Review previous inspection report and close
  • ut.
  • Check recalls
  • Check ARTG
  • Announcement letter is sent to company

confirming dates and which inspectors will be conducting the inspection

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SLIDE 4

The inspection

  • Introductions and show TGA identification
  • Agenda provided (next slides)
  • Scope of inspection verified
  • Company presentation (optional)
  • Attendance record
  • Daily close out (verbal) and final hard copy of observations (final day)

General Comments

  • Announced and Unannounced Inspections

The OPENING meeting

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SLIDE 5

The inspection

  • Personnel
  • Training
  • Quality System- Deviations, Change Controls, Complaints,

– Annual Product reviews, Recalls, self inspections, returned goods, hygiene and gowning, GMP Agreements, Supplier Approval, Rework, Reprocessing, Risk Management

  • Production
  • Engineering - calibration and maintenance
  • Utilities - HVAC, water systems, compressed air.
  • Validation documents
  • Chemistry and Microbiology
  • Batch records

What will be looked at:

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SLIDE 6

Post inspection

Post Inspection Letter (PIL)

  • Deficiencies issued and now classified as Critical, Major or Minor

Close Out Record

  • Company responds to the deficiencies. How you are going to correct identified

issues and timelines.

  • Inspector reviews the close out and accepts or rejects your proposals.
  • Three attempts to rectify
  • Once all have been accepted then a final Report will be issued
  • The report will contain both the good and areas for improvement seen at

inspection.

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SLIDE 7

Examples provided where GMP was not met

Two case studies

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SLIDE 8

Questions?

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SLIDE 9