PDA-数据完整性行为守则要素

PDA-数据完整性行为守则要素(中/英对照版)Parenteral Drug Association Points to Consider注射剂协会考虑要点Elements of a Code of Conduct for Data Integrity数据完整性行为守则要素Introduction简介Data Integrity has been and currently is a major global concern of Health Authorities and the pharmaceutical industry.Although not a new issue, numerous recent Health Authority enforcement actions such as Warning Letters, Import Alerts, Product Detentions, and suspension or revocation of Marketing Authorizations has focused attention on Data Integrity.Data Integrity can result from lack of awareness of regulatory requirements, employee errors, failure to check accuracy of data, software or system malfunction, or configuration problems with electronic data handling, or malfeasance by employees.To holistically address Data Integrity, the Parenteral Drug Association (PDA) is developing a set of tools in the form of PDA Technical Reports, PDA Training Program, Data Integrity Workshops, and Points to Consider documents that can be used by industry to address this serious issue.This document presents the views of the Parenteral Drug Association (PDA) on the benefits for companies to voluntarily adopt a Code of Conduct for assuring data integrity.数据完整性目前已经成为全球卫生机构与制药行业所关注的重点。尽管不是一个新的问题，近期在很多卫生当局的执法行动例如警告信、进口警报、产品扣留，以及暂时取消或撤销上市许可中都非常关注数据完整性的问题。数据完整性可能由于缺乏法规要求意识、员工错误、无法核实数据准确性，软件或系统故障，或电子数据处理配置问题，或员工渎职行为导致。为了全面解决数据完整性问题，注射剂协会(PDA)正在开发一套面向行业的涵盖PDA技术报告、PDA培训程序、数据完整性研讨会，以及考虑要点文件的工具来解决这一严重问题。本文件代表注射剂协会(PDA)的观点，公司可自愿采用行为守则来确保数据完整性。How to Use this Document如何使用本文件This document was developed by a team with expertise in the fields of quality, regulatory affairs, auditing, and manufacturing and reviewed by attorneys specialized in food, drug and labor law. This document is written for easy adoption, in part or in its entirety, by companies, if they so choose, without the need for extensive rewriting of the document. Therefore, the terms shall and must have been used to permit the Code to be enforceable by a company, if adopted. This document is intended to reinforce a culture of quality and trust within the pharmaceutical industry. It is not intended to be a regulatory standard or guidance, nor is it intended to supersede any country specific or local laws and regulations governing labor, privacy and/or employee rights.本文档由在质量、药政事务、审计及制造有专业知识的团队起草，并由专业从事食品、药物及劳动法的律师进行审核。对于部分选择或全部选择该文件的公司，该文件的编写易于使用且不需要大量文件的重新编辑。因此，如果使用的话，公司可以根据术语“应(should)”与“必须(must)”明确可执行的守则。本文件目的是在制药行业内加强质量与信任文化。该文件并不是药政标准或指南，也不打算取代任何国家特定或地方法律，以及监督劳动、隐私，和/或，雇员权利的法规。In order for the language used below to be as globally applicable as possible, the document scope has been limited to drug and biological medicinal products. The same or similar concepts could be applied for device and combination products manufacturing. PDA is providing this document and these concepts as a service to members and an example of best practices to the pharmaceutical industry. Please see Section 2 below for more details on how to use this code. Section 3 begins the code of conduct provisions.为了使下面使用的语言尽可能全球适用，该文件的范围仅限于药品与生物药品。相同或相似的概念也可以应用于医疗器械与组合产品的制造中。PDA将本文件和这些概念作为对会员的一种服务，并作为制药行业最佳实践的范例。关于如何使用本守则的更多详细内容请参考下面第二章。第三章是关于行为守则的条款。1.0 PURPOSE AND SCOPE第一章：目的与范围1.1The purpose of this document is to outline the key elements necessary to help ensure the reliability and integrity of information and data throughout all aspects of a products lifecycle. The Code of Conduct for Data Integrity is intended to apply to employees and officers and third party suppliers and others acting on behalf or at the behest of the company, such as persons that develop, test, manufacture or submit marketing authorizations for pharmaceutical and biological products. Each company will establish their own Policies, Standards, Procedures, Code of Conduct, or other quality system elements that define the requirements for data integrity (including the principles outlined in the Code of Conduct including:本文件目的在于概述必要的关键要素，以确保贯穿产品生命周期各个方面的信息和数据的可靠性与完整性。数据完整性行为守则旨在适用于员工、官员、第三方供应商以及代表公司或公司授意的其他行为，例如从事开发、检测、制造或提交药品或生物制品上市许可的人。每个公司应建立自己的方针、标准、规程、行为守则，或其他质量系统要素以明确数据完整性的要求(包括在行为守则中概述的基本原则):Manufacturers of finished drug products for clinical trials, bioequivalence studies, and commercial distribution临床试验、生物等效性研究和商业销售的制剂制造企业Companies that conduct clinical trials in support of new drug applications including, but not limited to: Investigational New Drug (IND), Clinical Trial Application (CTA), Investigational Medicinal Product Dossier (IMPD), Biologics License Application (BLA), Marketing Authorization Application (MAA), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA)开展临床试验以支持新药申请的公司，包括但不限于：研究用新药(IND)、临床试验申请(CTA)、研究用药品档案(IMPD)、生物制品许可申请(BLA)、上市许可申请(MAA)、新药申请(NDA)与简略新药申请(ANDA)Laboratories that develop methods or formulations intended to support new drug applications or laboratories that analyze samples generated from clinical trials开发分析方法或配方以支持新药申请的实验室或进行临床试验样品分析的实验室Manufacturer