GCP Inspections: Legal Basis
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1 Systems Inspections Workshop 24 April 2013 Dr Simone Ferbitz PhD, Eidg. Dipl. Pharm. ETH GCP Inspector, Swissmedic Swissmedic Schweizerisches Heilmittelinstitut Hallerstrasse 7 CH-3000 Bern GCP Inspections: Legal Basis TPA Art. 54, paragraph 4; OClin Art. 27: Swissmedic can perform inspections at any time. Sponsors, CROs, investigator sites, laboratories, etc. Inspection activity based on: Swiss law (TPA, Oclin) Guideline for good clinical practice (ICH Topic E6) Information on inspections WS Bern / S.Ferbitz Page 2
2 GCP Inspections: Terminology Routine inspections» Annual plan Triggered inspections» For Cause inspections» Related to the submission of a MAA WS Bern / S.Ferbitz Page 3 GCP Inspections: Definitions Systems inspections Sponsor / CROs» Study specific systems inspection» General systems inspection Site inspections»trial sites»cros Combined systems inspections WS Bern / S.Ferbitz Page 4
3 GCP Inspections: Process Selection Preparation Inspection Reporting Annual plan 4 6 weeks 3 5 days 2 days 4 weeks ahead WS Bern / S.Ferbitz Page 5 GCP Inspections: Process Selection Announce- ment Announce- ment Preparation Inspection Reporting Request of documentation (organigram, list of SOPs..) If applicable: Read previous inspection reports Identify issues of particular interest Prepare questionnaires (based on checklists) Define the documentation to be reviewed during the inspection Coordinate (inspection agenda) WS Bern / S.Ferbitz Page 6
4 GCP Inspections: Process Selection Preparation Inspection Reporting Important: t 4 eyes / 4 ears principle i Opening meeting Interviews Facilities tour Document review Closing meeting WS Bern / S.Ferbitz Page 7 GCP Inspections: Process Selection Announce- ment Announce- ment Preparation Inspection Reporting Inspection report is sent about 4 weeks after the inspection The inspected party has 4 weeks to respond and to submit a CAPA plan Swissmedic evaluates the CAPA plan As soon as the CAPA plan is accepted: the inspection is closed WS Bern / S.Ferbitz Page 8
5 Categorisation of findings Critical: Conditions, practices or processes that adversely affect the rights, safety or well being of the subjects and/or the quality and integrity of data Major: Conditions, practices or processes that might adversely affect the rights, safety or well being of the subjects and/or the quality and integrity of data Minor: Conditions, practices or processes that would not be expected to adversely affect the rights, safety or well being of the subjects and/or quality and integrity of data WS Bern / S.Ferbitz Page 9 GCP inspections: Statistics (CH, 2012) 10 commercial sponsors (N=7) related site inspections (N=8) sponsor- investigator (N=1) numbe r of inspe ections 5 CROs (phase I, laboratory) (N=3) WS Bern / S.Ferbitz Page 10
6 GCP inspections: Statistics (CH, 2012) 10 commercial sponsors (N=7) related site inspections (N=8) sponsor- investigator (N=1) numbe r of inspe ections 5 CROs (phase I, laboratory) (N=3) WS Bern / S.Ferbitz Page 11 Systems inspections: Triggers Inconsistencies i during the notification i process Vulnerable trial subject population High-risk studies Sponsor activity (many trials in parallel, many trial subjects) WS Bern / S.Ferbitz Page 12
7 Systems inspections: Topics Organisation / Personnel / Training / Qualification Quality Management System Trial management Monitoring Safety Reporting Procedures Facilities and equipment Investigational Medicinal Product Data handling and Clinical Trial Report Clinical Trial documentation Documentation archiving WS Bern / S.Ferbitz Page 13 Observed findings WS Bern / S.Ferbitz Page 14
8 Organisation / Personnel Organigram is not up-to-date Job descriptions/cvs:» no documentation» not signed/dated and no effective date» not in line with current function Lack of clearly defined responsibilities No deputy defined Double functions which are not compatible (e.g.: monitor controls its own work) WS Bern / S.Ferbitz Page 15 Training / Qualification No on-boarding and training concept No role specific SOP assignement SOP training:» Incomplete SOP training» Training not documented» Documentation fragmentary and inconsistent The training documentation of former personnel is not archived WS Bern / S.Ferbitz Page 16
9 Quality Management System Relevant processes are not defined in writing (cave: Swiss specific processes!) SOPs are not in line with the Swiss Legislation Non-adherence to SOPs Inconsistencies among SOPs Formal aspects (incorrect versioning, page numbering, annexes..) WS Bern / S.Ferbitz Page 17 Trial Management No documentation about which task has been delegated to another party (in house/external) Agreements:» Not dated, not signed by both parties Delayed submission of study documentation to Swissmedic (e.g. leading to a delayed information of trials subjects about important changes) Insufficient oversight by the sponsor (e.g. CRO activities, facilities) Work sheets provided to the sites: not in line with the CTP WS Bern / S.Ferbitz Page 18
10 Monitoring Non-adherence to the monitoring plan No or inadequate monitoring due to lack of resources Protocol violations are not detected adequately/in a timely manner by ongoing medical review WS Bern / S.Ferbitz Page 19 Safety Reporting procedures Non adherence to legal timelines of expedited reporting Non adherence to timely submission of ASR/PSUR Problems with electronic SAE reporting (e.g. programming errors) WS Bern / S.Ferbitz Page 20
11 Clinical Trial documentation/archiving Missing essential documents Documents spread over several repositories is insufficiently defined (cave: hybrid filing systems) The archiving process is not / insufficiently defined WS Bern / S.Ferbitz Page 21 Systems inspections: categorisation of findings (2012) # systems inspections: 11 # findings: WS Bern / S.Ferbitz Page 22
12 Thank you for your attention ti WS Bern / S.Ferbitz Page 23
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