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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
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GMP Inspection Process

Preparation for the Inspection


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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


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Preparation for an Inspection

Scope of Inspection

  • Objective

  • Type

  • Depth

  • Timing

  • Inspectors:

    • size of team

    • make-up of team


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Preparation for an Inspection

Notification

  • The company being inspected

  • Team members

    • expert support

    • other inspectors

  • Other interested parties


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Preparation for an Inspection

Review documentation from regulatory authority

  • Company file

  • Site Master File

  • Manufacturing licence

  • Registration dossiers


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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)


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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


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Preparation for an Inspection

Programme

  • Checklist

  • Aide-memoire for inspection

  • Develop inspection programme

  • Distribute inspection programme

    • Company

    • Team


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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


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Preparation for an Inspection

Possible Issues – I

The first inspection of a new manufacturer

  • Plant design and equipment

  • Processes

  • Documentation

  • Personnel

  • Quality control


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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


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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