SLIDE 1
Overview
- The inspection process
- What happens at inspection
- Two case studies
2
Through the eyes of an inspector GMP Forum Melbourne 21 November - - PowerPoint PPT Presentation
Through the eyes of an inspector GMP Forum Melbourne 21 November - - PowerPoint PPT Presentation
Through the eyes of an inspector GMP Forum Melbourne 21 November 2019 Greg Orders Senior Inspector Overview The inspection process What happens at inspection Two case studies 2 GMP inspection process PRIOR TO THE INSPECTION
SLIDE 2
SLIDE 3
GMP inspection process
PRIOR TO THE INSPECTION
- At least two weeks prior to the inspection you
will be contacted by the Lead inspector.
- Site Master File requested and maybe other
documents.
- Review previous inspection report and close
- ut.
- Check recalls
- Check ARTG
- Announcement letter is sent to company
confirming dates and which inspectors will be conducting the inspection
3
SLIDE 4
The inspection
- Introductions and show TGA identification
- Agenda provided (next slides)
- Scope of inspection verified
- Company presentation (optional)
- Attendance record
- Daily close out (verbal) and final hard copy of observations (final day)
General Comments
- Announced and Unannounced Inspections
The OPENING meeting
4
SLIDE 5
The inspection
- Personnel
- Training
- Quality System- Deviations, Change Controls, Complaints,
– Annual Product reviews, Recalls, self inspections, returned goods, hygiene and gowning, GMP Agreements, Supplier Approval, Rework, Reprocessing, Risk Management
- Production
- Engineering - calibration and maintenance
- Utilities - HVAC, water systems, compressed air.
- Validation documents
- Chemistry and Microbiology
- Batch records
What will be looked at:
5
SLIDE 6
Post inspection
Post Inspection Letter (PIL)
- Deficiencies issued and now classified as Critical, Major or Minor
Close Out Record
- Company responds to the deficiencies. How you are going to correct identified
issues and timelines.
- Inspector reviews the close out and accepts or rejects your proposals.
- Three attempts to rectify
- Once all have been accepted then a final Report will be issued
- The report will contain both the good and areas for improvement seen at
inspection.
6
SLIDE 7
Examples provided where GMP was not met
Two case studies
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SLIDE 8
Questions?
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SLIDE 9