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