JPMA Activity for Data Integrity GMP Discussion Forum (2017) Role and Responsibility of QC-Lab. - Laboratory control including Data Integrity - GMP Ca
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1 Data Reliability of QC-Lab. Japan Pharmaceutical Manufacturers Association (JPMA) Quality & Technology Committee Hiroshi Fujie 1
2 JPMA Activity for Data Integrity GMP Discussion Forum (2017) Role and Responsibility of QC-Lab. - Laboratory control including Data Integrity - GMP Case Study Seminar Current topics and Case study of JPMA member company for Data Integrity (2016) Case study of Data Integrity activity at JPMA member's manufacturing plant (2017) Data Integrity Working Team (2017-) 15 members are participating on the team to discuss how to implement Data Integrity at Japanese manufacturing sites *1: GMP News, Vol.117, 2017, JPMA *1 MHRA: GxP Data Integrity Definitions and Guidance for Industry WHO: Guidance On Good Data And Record Management Practices US FDA: Data Integrity And Compliance With cgmp PIC/S: Good Practices for Data Management and Integrity in regulated GMP/GDP Environments EMA: Q&A Data Integrity 2
3 Data Reliability of QC-Lab. Sampling Plans and Strategies Batch represented/adequate amount Sample Traceability Sampling SOP/QC oversight for sampling personnel QC-Testing Sample storage & identification/testing/raw data Data Processing Audit trail QC-testing data issue Data Integrity Data retention archive/retrieval/destruction 3
4 GMP Discussion Forum - Background of Data Integrity Survey - *1 Questionnaire was sent to 72 members of JPMA Quality & Technology Committee. Analysis was conducted on responses from 56 respondents 人以上 100 人未満 人以上 200 人未満 人以上 300 人未満 人以上 400 人未満 人以上 500 人未満 Number of Employees API (Chemical/Classical Fermentation) 原薬 ( 化学合成及び発酵 ) API (Biological/Vaccine/ Blood Preparation) 原薬 ( バイオ ワクチン 血液製剤 ) DP (Sterile) DS (Non-sterile) 無菌製剤 非無菌製剤 Manufactured Products 人以上 5 Packaging/Labeling 包装 *1: 45 th GMP Discussion Forum, JPMA, 3-Oct.,
5 Sample Traceability: Who carries out sampling at manufacturing area? Product Release Test (Bulk product / Finished product) All samples are taken by Manufacturing 21% 4% All samples are taken by QC 7% Most of the samples are taken by Manufacturing, but some of them are taken by QC 25% Most of the samples are taken by QC, but some of them are taken by Manufacturing 43% 5
6 Sample Traceability: Who carries out sampling at manufacturing area? In-Process Test 7% All samples are taken by QC 2% Most of the samples are taken by QC, but some of them are taken by Manufacturing 9% All samples are taken by Manufacturing 53% Most of the samples are taken by Manufacturing, but some of them are taken by QC 29% 6
7 Sample Traceability: Who carries out sampling at manufacturing area? Water and Environmental monitoring Test All samples are taken by Manufacturing 11% 11% All samples are taken by QC 25% Most of the samples are taken by Manufacturing, but some of them are taken by QC 23% Most of the samples are taken by QC, but some of them are taken by Manufacturing 30% 7
8 Sample Traceability: If QC doesn't carry out sampling, how to assure sample traceability. QC have a responsibility to train and qualify manufacturing personnel for sampling. QCが製造部門の職員を教育し サンプル採取者として認定している 47 Sampling procedure is defined by QC. QC がサンプリングに関する手順書を作成している 36 その他 ( 自由記載 :50 文字以内でご記入下さい ) QC check if sampling is carried out adequately by the personnel at manufacturing area. QCがサンプリング場所において 製造部門の職員が適切にサンプリングしていることを 定期的又は非定期に確認している
9 Sample Traceability: How to assure the reliability of QC-test results that are judged visually by analyst. Some kinds of tests (Color reaction/sterility/bioburden/tlc/etc.), the results are not recorded automatically. Both judgment and recording of test results are done by single analyst. In addition to original analyst, second analyst confirms test-results at Lab. 試験者に加えて 別の試験者が現場に立ち会い 結果を確認している 28 Test-results are recorded on photo/video by original analyst, then second analyst confirms the results at the Office. 試験結果を写真や動画で記録し これを試験者以外が確認している 試験者を信用しているので 特段の手順は設けていない Reliance on original analyst. No additional procedures are implemented. その他 ( 自由記載 :50 文字以内でご記入下さい )
10 Sample Traceability: Summary JPMA member companies have strict sample traceability to assure the reliability of QC-testing data. Even if manufacturing personnel carry out sampling, sampling operation is fully under QC control. Personnel who carry out sampling are trained and qualified by QC. Sampling procedure is defined by QC. QC check if sampling is carried out adequately by the personnel at manufacturing area. The reliability of QC-test results that are judged visually by analyst is adequately assured. The risk of data falsification is low. 10
11 Data Integrity: Have you developed Standards or SOPs for Data Integrity at your site? Under development (7%) Some requirements are described in SOP, but higher level documents (e.g. - Standard) have not been developed (5%) 20% Not yet 15% Completely developed 0% Almost developed 65% 11
12 Data Integrity: What requirements are defined in your SOP? 電子記録及びシステムに対するログイン管理の手順 ( 共有パスワードの禁止 アクセス権限の分離等 ) System security (Login ID/Pass word/access privileges) Audit Trail review Maintaining of data storage medium for the all periods of archiving オーディットトレイルの照査に係わる手順 電磁記録媒体の保管に関する手順 ( 媒体が記録を維持できる長期間の保管 ) Data life cycle (Data backup/disposal) データのライフサイクルに関する管理手順 ( バックアップ及び廃棄等 ) Data of Trial run/sst 試し打ち及び SST 等の記録の保管に関する手順 Training/Job description of data reviewer 記録の照査者の教育 又は職務要件 分析機器におけるオーディットトレイル機能の要件 Audit trail requirement of analytical equipment オーディットトレイル機能を有していない機器の管理に関する手順 Equipment without Audit Trail Protection of records/documents from loss 文書の紛失防止に関する手順 その他 ( 自由記載 :50 文字以内でご記入下さい )
13 Data Integrity: When are Audit Trail reviewed? Depend on the product/equipment (11%) Not yet (5%) 35% Just after testing 28% Periodical (Independent product release schedule) 19% Before product release 18% 13
14 Data Integrity: Who reviews Audit Trail? Other QC (Data reviewer/it/etc.) (7%) Two QC personnel (Supervisor/Manager/reviewer) (4%) 33% QC Analyst 4% QA 9% QC Supervisor 54% 14
15 Data Integrity: For equipment without electronic Audit Trail, how to assure Data Integrity. None (4%) Equipment is scheduled for replacement (4%) 14% Logbook is used to demonstrate changes to data. Electrical data is defined as original raw data. 9% Logbook is used to demonstrate changes to data. Paper document is defined as original raw data. 77% 15
16 Data Integrity: When will major equipment without electronic Audit Trail be replaced? Replacement schedule is being considered (9%) Equipment without audit trail will be replaced based on equipment life cycle (5%) Replacement is completed (4%) 22% No replacement schedule 18% Within 5 years 15% Within 1 year 16% Within 3 years 29% 16
17 How to control paper template used for QC-testing. Distribution of template is controlled by LIMS/CPU-system. Template is generated from LIMS/CPU-system (7%) Distribution of template is controlled by assigned QC people (2%) 11% Distribution of template is controlled by QA 11% Not controlled 9% Distribution of template is controlled by QC document management team 16% Distribution of template is controlled by QC supervisor 53% 17
18 Data Integrity: Summary The JPMA member companies have been working on Data Integrity, but we have room for improvement regarding Data Integrity requirements. Most companies have developed Standard/SOP for Data Integrity but the contents vary according the organization. Most companies have developed procedures for Audit Trail reviews, but reviewers and review timing vary according the organization. For equipment without Audit Trail, most companies use logbook to demonstrate changes to data, but 20% companies have no defined schedule of equipment replacement. 18
19 Conclusion Data Reliability of QC-Lab Sample Tractability and Data Integrity are important to achieve Data reliability of QC-Lab Sample Traceability JPMA member companies have a strict Sample Traceability. Data Integrity JPMA member companies have room to improve Data Integrity. JPMA activities JPMA will continue our activities to achieve storing Data Reliability in Japanese pharmaceutical companies. (e.g. -GMP Case Study Seminar, GMP Discussion Forum, Data Integrity Working Team) 19
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