【和訳】PIC/Sのデータインテグリティガイダンス【第25回】
![](https://fs.one-cmp.com/GMPP_cat_Others_9_cf14dc956d.png)
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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