Discussion of RQA Inspection Feedback Andy Fisher, Lead Senior GCP - - PowerPoint PPT Presentation

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Discussion of RQA Inspection Feedback Andy Fisher, Lead Senior GCP - - PowerPoint PPT Presentation

Aug 04, 2023 241 likes •402 views

Discussion of RQA Inspection Feedback Andy Fisher, Lead Senior GCP Inspector Dossier submission to Inspection There are no processes that define that the inspection must take place within a certain timescale post receipt of dossier. Scheduling

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Discussion of RQA Inspection Feedback

Andy Fisher, Lead Senior GCP Inspector

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Dossier submission to Inspection

There are no processes that define that the inspection must take place within a certain timescale post receipt of dossier. Scheduling of inspections is based on risk, unplanned triggers etc. We will look at ensuring that feedback to the organisation regarding the status of their inspection scheduling after a certain time has passed would be appropriate.

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46.5 35.5 34.5 29 20 40 60 80 100 120

Commercial Sponsor Commercial CRO Non Commercial Commercial Phase 1 Units

Days Since Last Inspetion Date/Last Document Provided

Reporting Time of GCP Inspection Reports 2015‐2016 (Individual Reports and Median)

42 37.5 49 20 20 40 60 80 100 120

Commercial Sponsor Commercial CRO Non Commercial Commercial Phase 1 Units

Days Since Last Inspetion Date/Last Document Provided

Reporting Time of GCP Inspection Reports 2016‐2017 (Individual Reports and Median)

92 52.5 33 8 20 40 60 80 100 120

Commercial Sponsor Commercial CRO Non Commercial Commercial Phase 1 Units

Days Since Last Inspetion Date/Last Document Provided

Reporting Time of GCP Inspection Reports 2017‐2018 (Individual Reports and Median)

GCP Inspection Reports (2015-2018)

2017-2018 is incomplete/not QC checked

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20 40 60 80 100 120 140 2004‐2005 2005‐2006 2006‐2007 2007‐2008 2008‐2009 2009‐2010 2010‐2011 2011‐2012 2012‐2013 2013‐2014 2014‐2015 2015‐2016 2016‐2017 2017‐2018 Days Between Last Inspection Date/Date Last Document Provided and Report Issue Date

Median Inspection Reporting Times

(Years 2004‐2005, 2005‐2006, 2006‐2007 and 20017‐2018 have not been QC checked and are incomplete. Some closing dates were not available at the times of the metrics report issue for the other years) Commercial Sponsor Commercial CRO Non Commercial Commercial Phase 1 Units Current SOP MEDIAN

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  • Timescale for report is after last site inspection
  • Full data for 2015-2017. 2017-2018 is on limited reports issued/data entered
  • Increase in 2017/2018 – may be lowered once all data collected
  • Median time is slightly beyond current target (35 calendar days) and slight

trend to longer timescales

  • Some late reports, but organisation is informed as is GCP Management
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GCP Inspection Closure Times (2015-2018)

2017-2018 is incomplete/not QC checked

132 108.5 131 55 50 100 150 200 250 300 350

Commercial Sponsor Commercial CRO Non Commercial Commercial Phase 1 Units

Days Between Report Issue and Closing Statement Issue

Closing time of GCP Inspection Reports 2015‐2016 (Individual Inspections and Median)

186 226 200.5 111 100 200 300 400 500 600 700

Commercial Sponsor Commercial CRO Non Commercial Commercial Phase 1 Units

Days Between Report Issue and Closing Statement Issue

Closing time of GCP Inspection Reports 2016‐2017 (Individual Inspections and Median)

59 194 76.5 76 50 100 150 200 250

Commercial Sponsor Commercial CRO Non Commercial Commercial Phase 1 Units

Days Between Report Issue and Closing Statement Issue

Closing time of GCP Inspection Reports 2017‐2018 (Individual Inspections and Median)

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50 100 150 200 250 300 350 2004‐2005 2005‐2006 2006‐2007 2007‐2008 2008‐2009 2009‐2010 2010‐2011 2011‐2012 2012‐2013 2013‐2014 2014‐2015 2015‐2016 2016‐2017 2017‐2018 Days Between Date of Report Issue and Date of Issue of Closing Statement

Median Inspection Closing Times

(Years 2004‐2005, 2005‐2006, 2006‐2007 and 20017‐2018 have not been QC checked and are incomplete. Some closing dates were not available at the times of the metrics report issue for the other years) Commercial Sponsor Commercial CRO Non Commercial Commercial Phase 1 Units MEDIAN

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  • Full data for 2015-2017. 2017-2018 is on limited reports issued/data entered
  • Timescale is from final report to closing statement, response review times are not

currently captured in our trackers

  • Shows an increasing trend in time to close inspections – potential reasons:
  • Patience waiting for additional responses
  • Impact Assessments/Investigations
  • Multiple Responses received
  • Quarterly Reporting
  • Delay in issue of closing statement
  • We will start to track MHRA GCP Inspectors response review times.
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Does the time taken reflect that lengths/complexity of reports and subsequent responses review etc. increases with non-compliance?

  • Metrics report 2016-2018 issued 11th May 2018.
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10 20 30 40 50 60 70 80 90 100 2004/2005* 2005/2006* 2006/2007* 2007/2008 2008/2009 2009/2010 2010/2011 2011/2012 2012/2013 2013/2014 2014/2015 2015/2016 2016/2017

Percentage Year (April - March) (*=no QC or incomplete)

Percentage of inspections with at least 1 critical finding

Commercial Non Commercial CRO Phase 1 Investigator Site

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10 20 30 40 50 60 70 80 90 100 2004/2005* 2005/2006* 2006/2007* 2007/2008 2008/2009 2009/2010 2010/2011 2011/2012 2012/2013 2013/2014 2014/2015 2015/2016 2016/2017

Percentage Year (April - March) (*=no QC or incomplete)

Percentage of inspections with at least 1 critical and/or major finding

Commercial Non Commercial CRO Phase 1 Investigator Site

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Reasons for increasing non-compliance? DISCUSSION?

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Internal Audit Reports

MHRA GCP Inspectors continue only to request these where considered necessary to investigate serious non-compliance. Evidence of auditing is requested, but this does not need audit reports.

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Remote Access to eCRF, eTMF

  • Organisations will regularly offer remote access for eCRF.
  • Set up of access to systems prior to inspection is required.
  • Remote access and inspection of eTMF is NOT undertaken.
  • Remote access to eCRF may be undertaken by inspectors as part of inspection

planning.

  • Access to eSystems is required during inspections.
  • Sometimes access is sometimes requested to be left open to systems that can be

remotely accessed post inspection as they may be useful to re visit as part of report writing (e.g. SOPs)

  • No plans to do remote inspections.
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Inspection Focus

eTMF

  • Unless a previous critical in this area so there is CAPA to assess, the eTMF system itself ad surrounding

processes are not a focus of the inspection, it only becomes so once it is has been seen to impede review

  • Check audit trail to see if TMF up to date (compliance check)
  • Organisation should be able to demonstrate compliance (that relates to subject safety and data integrity) –

eTMF systems vary in how easy this is to assess and this is substantial when compared to paper. If an

  • rganisation wishes to maintain a poor system that does not facilitate review, inspection time on site will

ultimately require to increase and critical findings issued.

  • Numerous examples of engagement with stakeholders on eTMF, including entire day workshop in 2017.

Completed Trial for discontinued Development Programme

  • Selection of trials to demonstrate processes too (e.g. Reporting, particular eSystem etc.) it is not just the

nature of the trial.

  • Any trial can be selected for compliance evaluation.

MHRA duplicated a finding (regarding RSI) from a PV inspection