11 REGULATORY ACTIONS IN RESPONSE TO DATA INTEGRITY FINDINGS／データインテグリティに関する所見に対応した規制措置
11.1 Deficiency references／不備に関する参照資料
11.1.1 The integrity of data is fundamental to good manufacturing practice and the requirements for good data management are embedded in the current PIC/S Guides to GMP/GDP for Medicinal products. The following table provides a reference point highlighting some of these existing requirements.
11.1.1 データの完全性はGMPの基本であり、適正なデータ管理の要件は、現行のPIC/S 医薬品に関するGMP/GDPガイドに組み込まれている。次の表に、これらの既存の要求事項についての参照先を示す。
| ALCOA principle ALCOA原則 |
PIC/S Guide to Good Manufacturing Practice for Medicinal products, PE 009 (Part I): PIC/S医薬品に関する優れた製造の実践ガイドPE 009 (パートI): |
PIC/S Guide to Good Manufacturing Practice for Medicinal products, PE 009 (Part II): PIC/S医薬品に関する優れた製造の実践ガイドPE 009 (パートII): |
Annex 11 (Computerized Systems) 附属書11（コンピュータ化システム） |
PIC/S Guide to Good Distribution Practice for Medicinal products, PE 011: PIC/S医薬品に関する優れた流通の実践ガイド PE 011: |
| Attributable 帰属性 |
[4.20, c & f], [4.21, c & i], [4.29 point 5] [4.29 5点目] |
[5.43], [6.14], [6.18], [6.52] | [2], [12.1], [12.4], [15] | [4.2.4], [4.2.5] |
| Legible 判読性 |
[4.1], [4.2], [4.7], [4.8], [4.9], [4.10] | [6.11], [6.14], [6.15], [6.50] | [4.8], [7.1], [7.2], [8.1], [9], [10], [17] | [4.2.3], [4.2.9] |
| Contemporaneous 同時性 |
[4.8] | [6.14] | [12.4], [14] | [4.1], [4.2.9] |
| Original 原本性 |
[4.9], [4.27], [Paragraph "Record"] [「記録」の項] |
[6.14], [6.15], [6.16] | [8.2], [9] | [4.2.5] |
| Accurate 正確性 |
[4.1], [6.17] | [5.40], [5.42], [5.45], [5.46], [5.47], [6.6] | [Paragraph "Principles"] [「原則」の項] [4.8], [5], [6], [7.2], [10], [11] |
[4.2.3] |
| Complete 完全性 |
[4.8] | [6.16], [6.50], [6.60], [6.61] | [4.8], [7.1], [7.2], [9] | [4.2.3], [4.2.5] |
| Consistent | [4.2] | [6.15], [6.50] |
[4.8], [5] |
[4.2.3] |
| 一貫性 | ||||
| Enduring 永続性 |
[4.1], [4.10] | [6.11], [6.12], [6.14] | [7.1], [17] | [4.2.6] |
| Available 利用可能性 |
[Paragraph “Principle”], [「原則」の項], [4.1] |
[6.12], [6.15], [6.16] |
[3.4], [7.1], [16], [17] |
[4.2.1] |
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