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 • 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 out. • Check recalls • Check ARTG • Announcement letter is sent to company confirming dates and which inspectors will be conducting the inspection 3
The inspection The OPENING meeting • 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 4
The inspection What will be looked at: • 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 5
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
Two case studies Examples provided where GMP was not met 7
Questions? 8
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