最新PDA-数据完整性行为守则要素(1).docx

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1、Four short words sum up what has lifted most successful individuals above the crowd: a little bit more.-author-datePDA-数据完整性行为守则要素(1)PDA-数据完整性行为守则要素(1)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

2、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

3、 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 employee

4、s.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

5、 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

6、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 a

7、nd 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 t

8、o 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 governin

9、g 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 b

10、e 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 examp

11、le 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

12、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 employe

13、es 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,

14、 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

15、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: Investigat

16、ional 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(C

17、TA)、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Manufacturers of excipients, intermediat

18、es, or active pharmaceutical ingredients (APIs)辅料、中间体或原料药(API)制造企业Contract manufacturing organizations (CMOs)合同制造组织 (CMO)Contract research organizations (CROs)合同研究组织 (CRO)Contract testing laboratories合同检测实验室Contractors, consultants, suppliers and vendors that provide services and data that support t

19、he production and control of APIs, drug or biological products提供支持API、药品或生物制品生产和控制的服务和数据的合同商、咨询顾问、供应商和卖方。1.2The Code of Conduct for Data Integrity is intended to apply to marketing authorization holders and pharmaceutical facilities performing services or providing products that are required to adhe

20、re to GXP practices in accordance with applicable laws, regulations and legislative directives of regulatory authorities including:数据完整性行为守则适用于根据以下相关的法律、法规和药政当局立法指令，提供符合GXP法规要求的服务和产品的上市许可持有人及药厂，包括：Good Manufacturing Practice (GMP)药品生产质量管理规范 (GMP)Good Clinical Practice (GCP)药品临床试验质量管理规范(GCP)Good Phar

21、macovigilance Practice (GVP)药品警戒管理规范(GVP)Good Laboratory Practice (GLP)药品非临床试验质量管理规范(GLP)Good Distribution Practices (GDP)药品流通质量管理规范(GDP)Good Tissue Practice (GTP)组织质量管理规范(GTP)1.3The principles outlined below are intended to identify key data integrity elements that companies may choose to incorpora

22、te into their applicable systems that define the policies, standards and requirements for the conduct of company management and each of its employees. The elements listed below may be used to create a standalone Code of Conduct that is specific to Data Integrity for GXP operations. Alternatively, th

23、e identified elements may be incorporated into a broader Code of Conduct that encompasses other aspects of business values and ethics that are beyond data integrity. The data integrity elements may be integrated with existing policies, standards or other documents that define requirements for the co

24、nduct of company management and its employees (such as Quality Agreements with supply chain partners).以下所述原则旨在辨识公司可能选择纳入其恰当系统的关键数据完整性要素，该系统用于明确公司管理层和每一个员工行为的方针、标准和要求。下列要素可用于建立独立的专门用于GXP操作的数据完整性行为守则。另外，被辨识的要素可以被纳入到更广泛的包括超越数据完整性的商业价值以及道德行为守则的行为守则中。数据完整性要素可以被合并在用于定义公司管理层及其员工行为要求的现有方针、标准或其他文件中（例如供应链合作伙伴

25、的质量协议)1.4Manufactures are responsible for ensuring that quality system elements have been established at each of its third party suppliers that provide products or services on behalf of or at the behest of the manufacturer. Manufacturers need to ensure that suppliers (such as contract laboratories,

26、CROs and CMOs) that operate as an extension of the manufacturer have defined the policies, standards and requirements for the conduct of company management and each of its employees.制造企业有责任确保代表制造企业或制造企业授意提供产品或服务的第三方供应企业已经建立了质量体系要素。制造企业需要确保作为其延伸操作的供应企业(诸如，合同实验室、合同研究组织与合同制造组织)已经定义了公司管理层与每个员工的行为方针、标准与要

27、求。2.0PREAMBLE第二章：序言2.1The pharmaceutical industry develops and manufactures drugs and biologics that help patients all over the world live longer, healthier lives. It is a privilege to work in an industry that makes a difference in the lives of patients. Every employee has a duty to engage in conduc

28、t to ensure that all stakeholders can trust employee decisions that are based on data and information that are accurate, truthful and complete.制药行业开发与制造药品与生物制品，用以帮助全世界的患者更长、更健康地生活。改变患者的生活是在这个行业工作的特权。每个员工都有责任使所有的利益相关方相信其决策是基于准确、真实和完整的数据和信息的。2.2Senior Management must establish quality standards, requi

29、rements and procedures, and is obligated to maintain and monitor the performance of the quality system that helps to ensure availability of safe and effective drugs. The company must maintain operational management oversight to demonstrate that each product has been developed, manufactured or tested

30、 under conditions that are designed to assure the reliability and integrity of information and data used to support its quality and fitness for use, and in accordance with applicable laws, regulations and legislative directives of the regulatory authorities. Ensuring data integrity means collecting,

31、 documenting, reporting, and retaining data and information in a manner that accurately, truthfully and completely represents what actually occurred.高级管理层必须建立质量标准、要求与规程，并有义务保持与监测质量体系的性能从而有助于确保获得安全并有效的药物。公司必须保持对运营管理的监督，以证明每个产品均在被设计可保证信息与数据可靠和完整的条件下开发、制造或检测，这些信息和数据被用于支持其质量与使用的适用性，并符合药政当局相关的法律、法规与立法法令。

32、确保数据完整性意味着通过准确、真实、完整地表示实际上发生的事件来收集、记录、报告与保存数据与信息。2.3Every employee at each company is responsible for his/her own conduct to maintain a bond of trust between the company and its stakeholders, namely the patients, health care providers, and regulators (i.e., to prevent a broken bond due to data integ

33、rity issues). Employees have a duty to perform their GXP functions in an ethical manner that meets company requirements and industry standards as articulated in company requirements, and in accordance with all relevant laws, regulations or legislative directives of regulatory authorities.每个公司的每一位员工应

34、对自身的行为负责，从而保持公司与利益相关方，即患者、卫生保健提供者与监督者之间的信任(也就是防止由于数据完整性问题破坏这一纽带)。员工有责任以道德的方式履行其GXP职能，以满足在公司要求中清楚表达的公司要求与行业标准，并符合所有药政当局相关法律、法规或立法指令。2.4Every employee is required to collect, analyze, report and retain information and data in a manner that accurately, truthfully and completely represents what actually

35、 occurred in either paper or electronic format in accordance with the company policies and procedures and applicable law.每一位员工需要按照公司方针、规程和适合的法律采用纸质或电子方式准确、真实、完整地收集、分析、报告与保存代表实际发生事件的信息与数据。2.5By adopting a voluntary Code of Conduct for Data Integrity (Code of Conduct) senior management is committed, a

36、s required by applicable law, to notify applicable licensing/regulatory authority(s) if the company discovers that a pending or approved marketing authorization or other submission to a regulatory authority contains an untrue statement of material fact or omits material facts (e.g. information is fa

37、lse, misleading, inaccurate or incomplete). If data, not submitted, but used to determine whether a product batch met specifications are later found to be false, misleading, inaccurate or incomplete, a company is committed to file the appropriate notifications to health authorities (i.e. Field Alert

38、, Biological Product Deviation Report (BPDR) or notification under the Falsified Medicines Directive(FMD). Where warranted, management is committed to; (1) providing full disclosure, (2) verifying that a full investigation is conducted, (3) implementing corrective and preventative actions to prevent

39、 recurrence, and (4) verifying the validity and reliability of the data and information filed with regulatory agencies. This includes correcting material facts (information and data that were filed previously, if found to be incorrect, untruthful, misleading or incomplete).通过自愿采用数据完整性行为守则(行为守则)，高级管理

40、层应依据适当的法律要求承诺，如果本公司发现某暂停或已经批准的上市许可或其他提交给药政机构的文件中存在不真实的重要事实声明或省略的重要事实(例如，虚假、误导、不准确或不完整的信息)，将通知相关的许可/药政当局。对于未提交，但被用来确定产品批次是否符合规格标准的数据，如果之后发现是虚假、误导、不准确或不完整的，公司承诺向卫生当局提交恰当的通知(例如，现场警报、生物产品偏差报告 (BPDR) 或在伪造药品法令(FMD)通知)。如必要，管理层应承诺; (1)充分披露信息，(2)确认开展全面调查，(3)实施纠正与预防措施，以防止再次发生，以及(4)确认已经提交给药政当局的数据与信息的有效性与可靠性。包括

41、纠正重要事实(已经提交的信息与数据，如果发现存在不正确、不真实、误导或不完整的情况)。3.0 ELEMENTS of a CODE OF CONDUCT FOR DATA INTEGRITY第三章：数据完整性行为守则要素3.1Applicability适用性3.1.1Each company that develops, tests and manufactures APIs, intermediates, or pharmaceutical and biological products or vendors/suppliers that provide supporting data ma

42、y adopt a company Code of Conduct for Data Integrity which establishes standards of ethical behavior for all employees and officers of the company.每个开发、检测与制造原料药、中间体，或药品与生物制品的公司或提供支持数据的供应商/供应方可采用公司数据完整性行为守则，从而建立适合公司全体员工与管理层的道德行为标准。3.1.2In support of this code companies will establish programs that: (

43、1) promote an organizational culture that encourages ethical conduct; (2) demonstrates the companys commitment to compliance with applicable laws; and (3) requires the prevention and detection of data integrity lapses.为了支持该守则，公司需建立的程序包括：(1)提倡一种鼓励道德操守的组织文化；(2)证明公司的承诺符合恰当的法律；以及(3)对数据完整性失误的预防与监测。3.1.3T

44、he company will establish requirements and implement programs to provide all employees with training on the fundamental principles of Data Integrity including employee conduct as a condition of performing GXP functions. Each employee shall receive annual refresher training on the Code of Conduct for

45、 Data Integrity公司应建立要求并实施程序，向所有员工开展有关数据完整性基本原则的培训，包括作为实施GXP职能条件的员工行为。每位员工需每年接受数据完整性行为守则的再培训。3.1.4Each employee will provide annually a signed certification statement confirming that during the past year he/she has adhered to the Code of Conduct for Data Integrity including attestation that he/she ha

46、s reported to company management wrongful act that raises a question about the integrity of data about which he/she became aware.每一位员工每年应提供签名的认证声明确认在过去一年里其遵守数据完整性守则，包括宣誓已经向公司管理层报告任何自身已经知晓的有关数据完整性问题的不法行为。3.2Data Collection, Analysis, Reporting and Retention数据采集、分析、报告与保存3.2.1The company will establish

47、 procedures and documentation systems designed to assure all information and data are collected, analyzed, reported, and retained in a manner that accurately, truthfully and completely represents what actually occurred.公司应建立规程与记录系统以确保所有的信息和数据以准确、真实和完整地表示实际发生情况的方式进行收集、分析、报告，与保存。3.2.2The company shall

48、 establish documentation control systems and practices to maintain data integrity as well as providing mechanisms for preventing data integrity lapses and detecting instances of non-compliance. Such systems help to ensure that all raw data from development studies and production and control activiti

49、es for GXP activities are maintained in bound notebooks or controlled worksheets (pre-numbered approved forms)for paper records or in validated computer systems with appropriate security, audit trails, validation, and oversight for electronic records.公司应建立文件控制系统与规范，以保持数据完整性，并提供防止数据完整性失误与监测不合规事件的机制。该系统可帮助确保所有针对GXP开展的开发研究、生产、控制活动的原始数据已经采用纸