GMP Inspection Process Preparation for the Inspection Module

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 l Objective l Type l Depth l Timing l Inspectors: ä size of team ä make-up of team Module 18 | Slide 3 of 12 January 2006

Preparation for an Inspection Notification l The company being inspected l Team members ä expert support ä other inspectors l Other interested parties Module 18 | Slide 4 of 12 January 2006

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

Preparation for an Inspection Review documentation from regulatory authority (continued) l Reports ä Adverse Drug Reaction reports (ADRs) ä Previous inspections l Records ä Complaints and recalls ä Regulatory test results (surveillance) Module 18 | Slide 6 of 12 January 2006

Preparation for an Inspection Review documentation from the manufacturer l Annual report l Complaints file l Self inspection/internal audit reports l Send a questionnaire to the manufacturer asking to provide specific information about the company l Layout of site and diagrams l Manuals l Standard Operating Procedures Module 18 | Slide 7 of 12 January 2006

Preparation for an Inspection Programme l Checklist l Aide-memoire for inspection l Develop inspection programme l Distribute inspection programme ä Company ä Team Module 18 | Slide 8 of 12 January 2006

Preparation for an Inspection Group Session l You will be given a situation that requires an inspection l Prepare a list of documents that you would use in preparation for the inspection l Prepare a checklist or aide-memoire of key issues to be investigated l 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 l Plant design and equipment l Processes l Documentation l Personnel l Quality control Module 18 | Slide 10 of 12 January 2006

Preparation for an Inspection Possible Issues – II Regular inspection of an established manufacturer l Actions arising from the previous inspection l Areas not previously inspected l 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 l The product in question l Manufacturing process l Premises l Systems for handling complaints and recalls l Quality control records Module 18 | Slide 12 of 12 January 2006