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