Transcript Preparation for an inspection

GMP Inspection Process
Preparation for the Inspection
Module 18 |
Slide 1 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
Module 18 |
Slide 2 of 12
January 2006
Preparation for an Inspection
Scope of Inspection
 Objective
 Type
 Depth
 Timing
 Inspectors:
 size of team
 make-up of team
Module 18 |
Slide 3 of 12
January 2006
Preparation for an Inspection
Notification
 The company being inspected
 Team members
 expert support
 other inspectors
 Other interested parties
Module 18 |
Slide 4 of 12
January 2006
Preparation for an Inspection
Review documentation from regulatory
authority
 Company file
 Site Master File
 Manufacturing licence
 Registration dossiers
Module 18 |
Slide 5 of 12
January 2006
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)
Module 18 |
Slide 6 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
Module 18 |
Slide 7 of 12
January 2006
Preparation for an Inspection
Programme
 Checklist
 Aide-memoire for inspection
 Develop inspection programme
 Distribute inspection programme
 Company
 Team
Module 18 |
Slide 8 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
Module 18 |
Slide 9 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
Module 18 |
Slide 10 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
Module 18 |
Slide 11 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
Module 18 |
Slide 12 of 12
January 2006