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GMP Inspection Process. Preparation for the Inspection. Preparation for an Inspection. Objectives 1. To review the activities in preparation for an inspection 2. To discuss key issues relating to preparing for inspections in this country. Preparation for an Inspection. Scope of Inspection

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Presentation Transcript
gmp inspection process
GMP Inspection Process

Preparation for the Inspection

preparation for an inspection
Preparation for an Inspection

Objectives

1. To review the activities in preparation for an inspection

2. To discuss key issues relating to preparing for inspections in this country

preparation for an inspection3
Preparation for an Inspection

Scope of Inspection

  • Objective
  • Type
  • Depth
  • Timing
  • Inspectors:
    • size of team
    • make-up of team
preparation for an inspection4
Preparation for an Inspection

Notification

  • The company being inspected
  • Team members
    • expert support
    • other inspectors
  • Other interested parties
preparation for an inspection5
Preparation for an Inspection

Review documentation from regulatory authority

  • Company file
  • Site Master File
  • Manufacturing licence
  • Registration dossiers
preparation for an inspection6
Preparation for an Inspection

Review documentation from regulatory authority (continued)

  • Reports
    • Adverse Drug Reaction reports (ADRs)
    • Previous inspections
  • Records
    • Complaints and recalls
    • Regulatory test results (surveillance)
preparation for an inspection7
Preparation for an Inspection

Review documentation from the manufacturer

  • Annual report
  • Complaints file
  • Self inspection/internal audit reports
  • Send a questionnaire to the manufacturer asking to provide specific information about the company
  • Layout of site and diagrams
  • Manuals
  • Standard Operating Procedures
preparation for an inspection8
Preparation for an Inspection

Programme

  • Checklist
  • Aide-memoire for inspection
  • Develop inspection programme
  • Distribute inspection programme
    • Company
    • Team
preparation for an inspection9
Preparation for an Inspection

Group Session

  • You will be given a situation that requires an inspection
  • Prepare a list of documents that you would use in preparation for the inspection
  • Prepare a checklist or aide-memoire of key issues to be investigated
  • Draft a programme for the inspection
preparation for an inspection10
Preparation for an Inspection

Possible Issues – I

The first inspection of a new manufacturer

  • Plant design and equipment
  • Processes
  • Documentation
  • Personnel
  • Quality control
preparation for an inspection11
Preparation for an Inspection

Possible Issues – II

Regular inspection of an established manufacturer

  • Actions arising from the previous inspection
  • Areas not previously inspected
  • New areas, processes and products
preparation for an inspection12
Preparation for an Inspection

Possible Issues – III

Inspection because of complaints about a product

  • The product in question
  • Manufacturing process
  • Premises
  • Systems for handling complaints and recalls
  • Quality control records
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