2017 GMP事例研究会 - jpma.or.jp

1 2017 GMP BMS data integrity BMS 1 data integrity : WHY NOW? BMS data integrity : BMS data integrity : Assessment 2 BMS data integrity 1960 6 113 4,000 2016 1,650 2017 4 3 -A 4 data integrity : WHY NOW? 5 data integrity : WHY NOW? data integrity MHRA GMP data integrity Definitions and Guidance for Industry March 2015 FDA: data integrity and Compliance With cGMP- Guidance for Industry (Draft April 2016) MHRA GxP data integrity Definitions and Guidance for Industry (Draft version for consultation July 2016) WHO Annex 5-Guidance on good data and record management practices (draft July 2016) EMA data integrity Guidance (Aug 2016) PIC/S Good Practices for data Management and integrity in Regulated GMP/GDP Environments (draft Aug 2016) 6 data integrity : WHY NOW?

2 data integrity ALCOA+ BMS BMS Attributable GMP Legible Contemporaneous Original Accurate 7 data integrity : WHY NOW? data integrity ALCOA+ BMS BMS Complete Consistent GMP / Enduring Available 8 data integrity : WHY NOW? * Source: FDA presentation for Society of Quality Assurance Annual Meeting, 30-Mar-2017 No DI deficiencies 35% With DI deficiencies 65% FDA WARNING LETTERS 2015 FDA WARNING LETTERS 2016 With DI deficiencies: 9 With DI deficiencies: 65% Without DI deficiencies: 35% Without DI deficiencies: data integrity : WHY NOW?

3 QC / SOP ID HPLC/GC QC / / FDA 483 Observations & ID 10 BMS data integrity : Jun 11 Global Team 2016/07 Lead site Project Kick off 2016/09 Assessment draft 2016/10 BMS Project Kick off 2016/11 Lead site assessment 2016/12 Training Material 2017/01 Assessment 2017/01 site Training 2017/02 BMS Global 2017/04 BMS assessment BMS data integrity : Jun 12 Te a m 2017/01 Project Kick off 2017/02 Training 2017/03 / 2017/04 2017/08 2017/09 Action Plan 2017/11 data integrity BMS data integrity : data integrity data integrity Global data integrity Assessment data integrity data integrity SOP 13 BMS data integrity : QA IT Assessment - 1 hour per system - 4 hours per system - 8 hours per process 14 Site Assessment Screening ALCOA+ QC System Assessment DI data Process Mapping GMP BMS data integrity : Assessment 15 BMS data integrity .

4 Assessment - Site Assessment 13 TRUE/PARTIAL/FALSE CSV 16 BMS data integrity : Assessment - Screening & System Assessment GMP GMP Priority 1 processes 1 17 Priority 1 1. 2. 3. 4. 5. 6. 7. 8. / / 9. 10. 11. 12. Priority 1 BMS data integrity : Assessment - Screening & System Assessment 18 PLC A PLC B IPC C Creation of BR Bulk product mfg Packaging (primary) Packaging (Secondary) QC (release) Settings data Analytical Batch Record Settings (analytical methods) data Examples of serious errors: Wrong expiry date Wrong sealing Wrong rejection parameters Wrong reporting of automation challenge result Alarms not reported Mfg Batch Record BMS data integrity : Assessment - Screening & System Assessment 19 - -ALCOA+ - data integrity - data integrity BMS data integrity : Assessment - Screening 20 ALCOA+ 5 6 DI BMS data integrity .

5 Assessment - System Assessment - - - -81 63 18 / / / / QC - 21 BMS data integrity : Assessment - data Process Mapping - - - - - - - -QC - - LIMS SAP 22 BMS data integrity : Assessment - data Process Mapping GMP 23 BMS data integrity : Next Step / / data integrity 24 BMS data integrity : data integrity data integrity / / 25 26