葛海虹2,
孙丹1
1. 上海化工院检测有限公司, 上海 200062;
2. 生态环境部固体废物与化学品管理技术中心, 北京 100029
作者简介: 汪丹(1986-),女,硕士,工程师,研究方向为计算机化系统验证和OECD GLP体系合规管理等,E-mail:wd@ghs.cn.
基金项目: 上海化工研究院科研计划项目（N307-2016jczx-01）中图分类号: X171.5
Computerized System Management Strategy Based on Data Integrity in Ecotoxicology GLP Laboratory
Wang Dan1,Ge Haihong2,
Sun Dan1
1. Shanghai Research Institute of Chemical Industry Testing Co. Ltd., Shanghai 200062, China;
2. Solid Waste and Chemicals Management Technology Center, Ministry of Ecology and Environment, Beijing 100029, China
CLC number: X171.5
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摘要:随着科学技术的进步，越来越多先进的自动化设备和计算机化系统进入良好实验室规范（GLP）领域，在享受着高新技术手段带来的高效和便利之时，实验室数据完整性管理也不断受到挑战，主要就是科学技术现代化水平不断升级与实验室内部管理手段应对不足的矛盾。目前，多个重要国家和组织陆续发出了计算机化系统验证和数据完整性管理的法规和指南，并积累了丰富的监管经验。本文梳理并总结了经济合作与发展组织（Organization for Economic Co-operation and Development，OECD）、国际制药工程协会（International Society of Pharmaceutical Engineers，ISPE）、国际药品认证合作组织（Pharmaceutical Inspection Co-operation Scheme，PIC/S）、欧洲原料药委员会（Active Pharmaceutical Ingredients Committee，APIC）等重要机构的数据完整性和计算机化系统要求，结合生态毒理GLP机构的发展需求，根据风险质量管理、计算机化系统验证和数据完整性管理的要求，建立了一种基于数据完整性的计算机化系统分级管理策略。通过信息收集、分类分级、措施评估和措施管理四步法，提出了计算机化系统管理中数据完整性措施的管理思路，该方法具有集约化、策略化和科学化的特点，有助于生态毒理GLP机构提升计算机化系统应用和管理能力，推进我国GLP机构国际化发展进程。
关键词: 数据完整性/
计算机化系统管理/
GLP良好实验室管理
Abstract:With the improvement of science and technology, more and more advanced automation equipment and computerized systems are applied in Good Laboratory Practice (GLP) field. The advanced technology brings high-efficiency and convenience, but the data integrity management is constantly challenged. The main conflict is between the continuous upgrading of modern science technology and the inadequate management strategy in GLP organizations. At present, many governments and authorities have been developing the regulatory guidelines on computerized system validation and data integrity, and have accumulated rich experience in monitoring and inspection. The paper examines and summarizes the requirements of the international guidelines, including Organization for Economic Co-operation and Development (OECD), International Society of Pharmaceutical Engineers (ISPE), Pharmaceutical Inspection Co-operation Scheme (PIC/S), Active Pharmaceutical Ingredients Committee (APIC), etc.. A classification strategy model based on data integrity is introduced to satisfy the development demand of eco-toxicology GLP lab and help the management become more intensive, strategic and scientific. Based on data integrity principle and risk assessment, a four-step method including information collection, classification and categorization, measures assessment and measures management is established. This method is helpful for elevating the application level of computerized system and promoting the international GLP development process.
Key words:data integrity/
computerized system management/
GLP compliance management.
| Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (Draft 3):PI 041-1.[EB/OL]. (2018-11-30)[2020-06-08]. https://picscheme.org/docview/2342 |
| The United States Pharmacopeial Convention. United States Pharmacopeia. Chapter <1058>. Analytical Instrument Qualification[EB/OL]. 2nd ed. (2019-01-31)[2020-06-08]. https://hmc.usp.org/system/files/general-chapters/GC-Pdfs_2019/_1058_%20ANALYTICAL%20INST-RUMENT%20QUALIFICATION.pdf |
| International Society for Pharmaceutical Engineering. GAMP® Good Practice Guide:A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems[EB/OL]. 2nd ed.[2020-06-08]. www.ispe.org |
| Active Pharmaceutical Ingredients Committee. Practical risk-based guide for managing data integrity[EB/OL]. 1st ed. (2019-03-01)[2020-06-07]. https://www.apic.cefic.org/pub/Data_Integrity_Best_Practices_Guide_for_API_FINAL_March-2019.pdf |
| 孟紫强. 现代环境毒理学[M]. 北京:中国环境科学出版社, 2015:12 Meng Z Q. Modern Environmental Toxicology[M]. Beijing:China Environmental Science Press, 2015:12(in Chinese) |
| 霍桂桃, 张曦, 吕建军, 等. 药物临床前安全评价机构计算机化系统的验证[J]. 药物评价研究, 2017, 40(11):1525-1530Huo G T, Zhang X, Lv J J, et al. Validation of computerized system in facilities for preclinical safety evaluation of drugs[J]. Drug Evaluation Research, 2017, 40(11):1525-1530(in Chinese) |
| International Society for Pharmaceutical Engineering. GAMP® Guide:Records & Data Integrity[EB/OL]. (2017-03-01)[2020-06-08]. www.ISPE.org |
| McDowall R D. Data Integrity and Data Governance:Practical Implementation in Regulated Laboratories[M]. Surrey Croydon:CPI Group (UK) Ltd, 2019:330-331 |
| Burgess C, McDowall R D. An integrated risk assessment for analytical instruments and computerized laboratory systems[J]. Spectroscopy, 2013, 28(11):1-7 |
| Liscouski J. Computerized Systems in the Modern Laboratory:A Practical Guide[M]. PDA and Davis Healthcare International, 2015:4 |
