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1. GMP Inspection Process
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Module18 Slide1of 12 January2006
Preparation for the Inspection

2. Preparation for an Inspection
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Module18 Slide2of 12 January2006
Objectives
1. To review the activities in preparation for an inspection
2. To discuss key issues relating to preparing for inspections in this
country

3. Preparation for an Inspection
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Module18 Slide3of 12 January2006
Scope of Inspection
 Objective
 Type
 Depth
 Timing
 Inspectors:
 size of team
 make-up of team

4. Preparation for an Inspection
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Module18 Slide4of 12 January2006
Notification
 The company being inspected
 Team members
 expert support
 other inspectors
 Other interested parties

5. Preparation for an Inspection
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Module18 Slide5of 12 January2006
Review documentation from regulatory
authority
 Company file
 Site Master File
 Manufacturing licence
 Registration dossiers

6. Preparation for an Inspection
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Module18 Slide6of 12 January2006
Review documentation from regulatory
authority (continued)
 Reports
 Adverse Drug Reaction reports (ADRs)
 Previous inspections
 Records
 Complaints and recalls
 Regulatory test results (surveillance)

7. Preparation for an Inspection
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Module18 Slide7of 12 January2006
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

8. Preparation for an Inspection
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Module18 Slide8of 12 January2006
Programme
 Checklist
 Aide-memoire for inspection
 Develop inspection programme
 Distribute inspection programme
 Company
 Team

9. Preparation for an Inspection
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Module18 Slide9of 12 January2006
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

10. Preparation for an Inspection
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Module18 Slide10of 12 January2006
Possible Issues – I
The first inspection of a new manufacturer
 Plant design and equipment
 Processes
 Documentation
 Personnel
 Quality control

11. Preparation for an Inspection
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Module18 Slide11of 12 January2006
Possible Issues – II
Regular inspection of an established manufacturer
 Actions arising from the previous inspection
 Areas not previously inspected
 New areas, processes and products

12. Preparation for an Inspection
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Module18 Slide12of 12 January2006
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