1. Module 18 | Slide 1 of 12 January 2006 GMP Inspection Process Preparation for the Inspection

2. Module 18 | Slide 2 of 12 January 2006 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

3. Module 18 | Slide 3 of 12 January 2006 Preparation for an Inspection Scope of Inspection Objective Type Depth Timing Inspectors: äsize of team ämake-up of team

4. Module 18 | Slide 4 of 12 January 2006 Preparation for an Inspection Notification The company being inspected Team members äexpert support äother inspectors Other interested parties

5. Module 18 | Slide 5 of 12 January 2006 Preparation for an Inspection Review documentation from regulatory authority Company file Site Master File Manufacturing licence Registration dossiers

6. Module 18 | Slide 6 of 12 January 2006 Preparation for an Inspection Review documentation from regulatory authority (continued) Reports äAdverse Drug Reaction reports (ADRs) äPrevious inspections Records äComplaints and recalls äRegulatory test results (surveillance)

7. Module 18 | Slide 7 of 12 January 2006 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

8. Module 18 | Slide 8 of 12 January 2006 Preparation for an Inspection Programme Checklist Aide-memoire for inspection Develop inspection programme Distribute inspection programme äCompany äTeam

9. Module 18 | Slide 9 of 12 January 2006 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

10. Module 18 | Slide 10 of 12 January 2006 Preparation for an Inspection Possible Issues – I The first inspection of a new manufacturer Plant design and equipment Processes Documentation Personnel Quality control

11. Module 18 | Slide 11 of 12 January 2006 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

12. Module 18 | Slide 12 of 12 January 2006 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