PDA-數(shù)據(jù)完整性行為守則要素

1、PDA-數(shù)據(jù)完整性行為守則要素(中/英對照版)徐禾豐2016-04-22 09:53 來自QQ空間日志Parenteral Drug Association Points to Consider注射劑協(xié)會考慮要點(diǎn)Elements of a Code of Conduct for Data Integrity數(shù)據(jù)完整性行為守則要素Introduction簡介Data Integrity has been and currently is a major global concern of Health Authorities and the pharmaceutical industry. Al

2、though 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 req

3、uirements, 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 o

4、f 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

5、Conduct for assuring data integrity.數(shù)據(jù)完整性目前已經(jīng)成為全球衛(wèi)生機(jī)構(gòu)與制藥行業(yè)所關(guān)注的重點(diǎn)。盡管不是一個新的問題，近期在很多衛(wèi)生當(dāng)局的執(zhí)法行動例如警告信、進(jìn)口警報、產(chǎn)品扣留，以及暫時取消或撤銷上市許可中都非常關(guān)注數(shù)據(jù)完整性的問題。數(shù)據(jù)完整性可能由于缺乏法規(guī)要求意識、員工錯誤、無法核實(shí)數(shù)據(jù)準(zhǔn)確性，軟件或系統(tǒng)故障，或電子數(shù)據(jù)處理配置問題，或員工瀆職行為導(dǎo)致。為了全面解決數(shù)據(jù)完整性問題，注射劑協(xié)會(PDA)正在開發(fā)一套面向行業(yè)的涵蓋PDA技術(shù)報告、PDA培訓(xùn)程序、數(shù)據(jù)完整性研討會，以及考慮要點(diǎn)文件的工具來解決這一嚴(yán)重問題。本文件代表注射劑協(xié)會(PDA)的觀點(diǎn)，公

6、司可自愿采用行為守則來確保數(shù)據(jù)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 i

7、n 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 th

8、e 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.本文檔由在質(zhì)量、藥政事務(wù)、審計(jì)及制造有專業(yè)知識的團(tuán)隊(duì)起草，并由專業(yè)從事食品、藥物及勞動法的律師進(jìn)行審核。對于部分選擇或全部選擇該文件的公司，該文件的編寫易于使用且不

9、需要大量文件的重新編輯。因此，如果使用的話，公司可以根據(jù)術(shù)語“應(yīng)(should)”與“必須(must)”明確可執(zhí)行的守則。本文件目的是在制藥行業(yè)內(nèi)加強(qiáng)質(zhì)量與信任文化。該文件并不是藥政標(biāo)準(zhǔn)或指南，也不打算取代任何國家特定或地方法律，以及監(jiān)督勞動、隱私，和/或，雇員權(quán)利的法規(guī)。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 s

10、ame 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.

11、Section 3 begins the code of conduct provisions.為了使下面使用的語言盡可能全球適用，該文件的范圍僅限于藥品與生物藥品。相同或相似的概念也可以應(yīng)用于醫(yī)療器械與組合產(chǎn)品的制造中。PDA將本文件和這些概念作為對會員的一種服務(wù)，并作為制藥行業(yè)最佳實(shí)踐的范例。關(guān)于如何使用本守則的更多詳細(xì)內(nèi)容請參考下面第二章。第三章是關(guān)于行為守則的條款。1.0 PURPOSE AND SCOPE第一章：目的與范圍1.1The purpose of this document is to outline the key elements necessary to help e

12、nsure the reliability and integrity of information and data throughout all aspects of a product's 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 person

13、s 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 pri

14、nciples outlined in the Code of Conduct including:本文件目的在于概述必要的關(guān)鍵要素，以確保貫穿產(chǎn)品生命周期各個方面的信息和數(shù)據(jù)的可靠性與完整性。數(shù)據(jù)完整性行為守則旨在適用于員工、官員、第三方供應(yīng)商以及代表公司或公司授意的其他行為，例如從事開發(fā)、檢測、制造或提交藥品或生物制品上市許可的人。每個公司應(yīng)建立自己的方針、標(biāo)準(zhǔn)、規(guī)程、行為守則，或其他質(zhì)量系統(tǒng)要素以明確數(shù)據(jù)完整性的要求(包括在行為守則中概述的基本原則):·Manufacturers of finished drug products for clinical trials, bi

15、oequivalence studies, and commercial distribution臨床試驗(yàn)、生物等效性研究和商業(yè)銷售的制劑制造企業(yè)·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),

16、 Biologics License Application (BLA), Marketing Authorization Application (MAA), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA)開展臨床試驗(yàn)以支持新藥申請的公司，包括但不限于：研究用新藥(IND)、臨床試驗(yàn)申請(CTA)、研究用藥品檔案(IMPD)、生物制品許可申請(BLA)、上市許可申請(MAA)、新藥申請(NDA)與簡略新藥申請(ANDA)·Laboratories that develop methods

17、 or formulations intended to support new drug applications or laboratories that analyze samples generated from clinical trials開發(fā)分析方法或配方以支持新藥申請的實(shí)驗(yàn)室或進(jìn)行臨床試驗(yàn)樣品分析的實(shí)驗(yàn)室·Manufacturers of excipients, intermediates, or active pharmaceutical ingredients (APIs)輔料、中間體或原料藥(API)制造企業(yè)·Contract manufacturin

18、g organizations (CMOs)合同制造組織 (CMO)·Contract research organizations (CROs)合同研究組織 (CRO)·Contract testing laboratories合同檢測實(shí)驗(yàn)室·Contractors, consultants, suppliers and vendors that provide services and data that support the production and control of APIs, drug or biological products提供支持API

19、、藥品或生物制品生產(chǎn)和控制的服務(wù)和數(shù)據(jù)的合同商、咨詢顧問、供應(yīng)商和賣方。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 adhere to GXP practices in accordance with applicable laws, regulations a

20、nd legislative directives of regulatory authorities including:數(shù)據(jù)完整性行為守則適用于根據(jù)以下相關(guān)的法律、法規(guī)和藥政當(dāng)局立法指令，提供符合GXP法規(guī)要求的服務(wù)和產(chǎn)品的上市許可持有人及藥廠，包括：·Good Manufacturing Practice (GMP)藥品生產(chǎn)質(zhì)量管理規(guī)范 (GMP)·Good Clinical Practice (GCP)藥品臨床試驗(yàn)質(zhì)量管理規(guī)范(GCP)·Good Pharmacovigilance Practice (GVP)藥品警戒管理規(guī)范(GVP)·Good

21、 Laboratory Practice (GLP)藥品非臨床試驗(yàn)質(zhì)量管理規(guī)范(GLP)·Good Distribution Practices (GDP)藥品流通質(zhì)量管理規(guī)范(GDP)·Good Tissue Practice (GTP)組織質(zhì)量管理規(guī)范(GTP)1.3The principles outlined below are intended to identify key data integrity elements that companies may choose to incorporate into their applicable systems

22、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, the identified elements may be inco

23、rporated 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 conduct of company management and i

24、ts employees (such as Quality Agreements with supply chain partners).以下所述原則旨在辨識公司可能選擇納入其恰當(dāng)系統(tǒng)的關(guān)鍵數(shù)據(jù)完整性要素，該系統(tǒng)用于明確公司管理層和每一個員工行為的方針、標(biāo)準(zhǔn)和要求。下列要素可用于建立獨(dú)立的專門用于GXP操作的數(shù)據(jù)完整性行為守則。另外，被辨識的要素可以被納入到更廣泛的包括超越數(shù)據(jù)完整性的商業(yè)價值以及道德行為守則的行為守則中。數(shù)據(jù)完整性要素可以被合并在用于定義公司管理層及其員工行為要求的現(xiàn)有方針、標(biāo)準(zhǔn)或其他文件中（例如供應(yīng)鏈合作伙伴的質(zhì)量協(xié)議)1.4Manufactures are respons

25、ible 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, CROs and CMOs) that operate as an

26、 extension of the manufacturer have defined the policies, standards and requirements for the conduct of company management and each of its employees.制造企業(yè)有責(zé)任確保代表制造企業(yè)或制造企業(yè)授意提供產(chǎn)品或服務(wù)的第三方供應(yīng)企業(yè)已經(jīng)建立了質(zhì)量體系要素。制造企業(yè)需要確保作為其延伸操作的供應(yīng)企業(yè)(諸如，合同實(shí)驗(yàn)室、合同研究組織與合同制造組織)已經(jīng)定義了公司管理層與每個員工的行為方針、標(biāo)準(zhǔn)與要求。2.0PREAMBLE第二章：序言2.1The pharmac

27、eutical 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 conduct to ensure that all stakeholders

28、 can trust employee decisions that are based on data and information that are accurate, truthful and complete.制藥行業(yè)開發(fā)與制造藥品與生物制品，用以幫助全世界的患者更長、更健康地生活。改變患者的生活是在這個行業(yè)工作的特權(quán)。每個員工都有責(zé)任使所有的利益相關(guān)方相信其決策是基于準(zhǔn)確、真實(shí)和完整的數(shù)據(jù)和信息的。2.2Senior Management must establish quality standards, requirements and procedures, and is ob

29、ligated 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 under conditions that are design

30、ed 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, documenting, reporting, and reta

31、ining data and information in a manner that accurately, truthfully and completely represents what actually occurred.高級管理層必須建立質(zhì)量標(biāo)準(zhǔn)、要求與規(guī)程，并有義務(wù)保持與監(jiān)測質(zhì)量體系的性能從而有助于確保獲得安全并有效的藥物。公司必須保持對運(yùn)營管理的監(jiān)督，以證明每個產(chǎn)品均在被設(shè)計(jì)可保證信息與數(shù)據(jù)可靠和完整的條件下開發(fā)、制造或檢測，這些信息和數(shù)據(jù)被用于支持其質(zhì)量與使用的適用性，并符合藥政當(dāng)局相關(guān)的法律、法規(guī)與立法法令。確保數(shù)據(jù)完整性意味著通過準(zhǔn)確、真實(shí)、完整地表示實(shí)際上發(fā)生的事件來收

32、集、記錄、報告與保存數(shù)據(jù)與信息。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 integrity issues). Employees have a du

33、ty 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.每個公司的每一位員工應(yīng)對自身的行為負(fù)責(zé)，從而保持公司與利益相關(guān)方，即患者、衛(wèi)生保健提供者

34、與監(jiān)督者之間的信任(也就是防止由于數(shù)據(jù)完整性問題破壞這一紐帶)。員工有責(zé)任以道德的方式履行其GXP職能，以滿足在公司要求中清楚表達(dá)的公司要求與行業(yè)標(biāo)準(zhǔn)，并符合所有藥政當(dāng)局相關(guān)法律、法規(guī)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 occurred in either paper or elec

35、tronic format in accordance with the company policies and procedures and applicable law.每一位員工需要按照公司方針、規(guī)程和適合的法律采用紙質(zhì)或電子方式準(zhǔn)確、真實(shí)、完整地收集、分析、報告與保存代表實(shí)際發(fā)生事件的信息與數(shù)據(jù)。2.5By adopting a voluntary Code of Conduct for Data Integrity (Code of Conduct) senior management is committed, as required by applicable law, to

36、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 false, misleading, inaccurate or in

37、complete). 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, Biological Product Deviation Re

38、port (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 recurrence, and (4) verifying th

39、e 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).通過自愿采用數(shù)據(jù)完整性行為守則(行為守則)，高級管理層應(yīng)依據(jù)適當(dāng)?shù)姆梢蟪兄Z，如果本公司發(fā)現(xiàn)某暫?；蛞呀?jīng)批準(zhǔn)的上市許

40、可或其他提交給藥政機(jī)構(gòu)的文件中存在不真實(shí)的重要事實(shí)聲明或省略的重要事實(shí)(例如，虛假、誤導(dǎo)、不準(zhǔn)確或不完整的信息)，將通知相關(guān)的許可/藥政當(dāng)局。對于未提交，但被用來確定產(chǎn)品批次是否符合規(guī)格標(biāo)準(zhǔn)的數(shù)據(jù)，如果之后發(fā)現(xiàn)是虛假、誤導(dǎo)、不準(zhǔn)確或不完整的，公司承諾向衛(wèi)生當(dāng)局提交恰當(dāng)?shù)耐ㄖ?例如，現(xiàn)場警報、生物產(chǎn)品偏差報告 (BPDR) 或在偽造藥品法令(FMD)通知)。如必要，管理層應(yīng)承諾; (1)充分披露信息，(2)確認(rèn)開展全面調(diào)查，(3)實(shí)施糾正與預(yù)防措施，以防止再次發(fā)生，以及(4)確認(rèn)已經(jīng)提交給藥政當(dāng)局的數(shù)據(jù)與信息的有效性與可靠性。包括糾正重要事實(shí)(已經(jīng)提交的信息與數(shù)據(jù)，如果發(fā)現(xiàn)存在不正確、不真實(shí)、誤

41、導(dǎo)或不完整的情況)。3.0 ELEMENTS of a CODE OF CONDUCT FOR DATA INTEGRITY第三章：數(shù)據(jù)完整性行為守則要素3.1Applicability適用性3.1.1Each company that develops, tests and manufactures APIs, intermediates, or pharmaceutical and biological products or vendors/suppliers that provide supporting data may adopt a company Code of Conduct

42、 for Data Integrity which establishes standards of ethical behavior for all employees and officers of the company.每個開發(fā)、檢測與制造原料藥、中間體，或藥品與生物制品的公司或提供支持?jǐn)?shù)據(jù)的供應(yīng)商/供應(yīng)方可采用公司數(shù)據(jù)完整性行為守則，從而建立適合公司全體員工與管理層的道德行為標(biāo)準(zhǔn)。3.1.2In support of this code companies will establish programs that: (1) promote an organizational cult

43、ure that encourages ethical conduct; (2) demonstrates the company's commitment to compliance with applicable laws; and (3) requires the prevention and detection of data integrity lapses.為了支持該守則，公司需建立的程序包括：(1)提倡一種鼓勵道德操守的組織文化；(2)證明公司的承諾符合恰當(dāng)?shù)姆?；以?3)對數(shù)據(jù)完整性失誤的預(yù)防與監(jiān)測。3.1.3The company will establish re

44、quirements 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 Data Integrity公司應(yīng)建立要求并實(shí)施程序，

45、向所有員工開展有關(guān)數(shù)據(jù)完整性基本原則的培訓(xùn)，包括作為實(shí)施GXP職能條件的員工行為。每位員工需每年接受數(shù)據(jù)完整性行為守則的再培訓(xùn)。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 has reported to company manage

46、ment wrongful act that raises a question about the integrity of data about which he/she became aware.每一位員工每年應(yīng)提供簽名的認(rèn)證聲明確認(rèn)在過去一年里其遵守?cái)?shù)據(jù)完整性守則，包括宣誓已經(jīng)向公司管理層報告任何自身已經(jīng)知曉的有關(guān)數(shù)據(jù)完整性問題的不法行為。3.2Data Collection, Analysis, Reporting and Retention數(shù)據(jù)采集、分析、報告與保存3.2.1The company will establish procedures and documentatio

47、n 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.公司應(yīng)建立規(guī)程與記錄系統(tǒng)以確保所有的信息和數(shù)據(jù)以準(zhǔn)確、真實(shí)和完整地表示實(shí)際發(fā)生情況的方式進(jìn)行收集、分析、報告，與保存。3.2.2The company shall establish documentation con

48、trol 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 activities for GXP activities are ma

49、intained 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.公司應(yīng)建立文件控制系統(tǒng)與規(guī)范，以保持?jǐn)?shù)據(jù)完整性，并提供防止數(shù)據(jù)完整性失誤與監(jiān)測不合規(guī)事件的機(jī)制。該系統(tǒng)可幫助確保所有針對GXP開展的開發(fā)研究、生產(chǎn)、控制活

50、動的原始數(shù)據(jù)已經(jīng)采用紙質(zhì)記錄或電子記錄的方式被保存在裝訂的筆記本或受控的工作表(預(yù)先編號的批準(zhǔn)的格式)中，對于電子記錄應(yīng)采用經(jīng)驗(yàn)證有適當(dāng)?shù)陌踩浴徲?jì)追蹤、驗(yàn)證和監(jiān)督的計(jì)算機(jī)系統(tǒng)。3.2.3Employees will adhere to the requirements of the established documentation systems and shall not be permitted to record raw data on unofficial forms, writing pads or other uncontrolled media. Such procedur

51、es will describe documentation control practices and retention requirements and practices for both paper and electronic records including retention periods that comply with requirements of applicable regulatory authorities. Paper and electronic records shall be retained either as originals or as tru

52、e copies (such as photocopies) or other accurate reproductions of the original record (such as electronic scanning).員工需遵守既定的文件系統(tǒng)要求，且不允許在非正式表格、手寫板或其他非受控媒介上記錄原始數(shù)據(jù)。該規(guī)程將描述適用于紙質(zhì)與電子記錄的文件控制規(guī)范，保存要求和規(guī)范，包括符合相關(guān)藥政當(dāng)局要求的保留期。紙質(zhì)和電子記錄的保存應(yīng)采用正本或真實(shí)副本(例如影印件)或其它正本記錄的準(zhǔn)確復(fù)印件 (例如電子掃描)。3.2.4Employees will adhere to establishe

53、d company procedures that describe the documentation control and retention requirements, and applicable laws, regulations and legislative directives of regulatory authorities that apply to paper and electronic documents and records. Employees shall not discard, destroy, or modify in any way raw data

54、 or original records (other than at the end of prescribed retention period as provided by approved procedures). Employees shall not delete raw data or alter original records in a manner that obscures or obliterates the original entries. If changes are needed to correct errors, the original entries s

55、hall be retained along with entries that identify the person making the correction, and the date and reason for the correction.員工需遵守已建立的有關(guān)紙質(zhì)與電子文件和記錄的文件控制與保存要求、恰當(dāng)?shù)姆?、法?guī)與藥政當(dāng)局立法法令的公司規(guī)程。員工不應(yīng)以任何方式丟棄、銷毀或修改原始數(shù)據(jù)或原始記錄(除非根據(jù)批準(zhǔn)的程序在規(guī)定的保留期結(jié)束時)。員工不得刪除原始數(shù)據(jù)或以模糊或涂改原始記錄的方式改變原始記錄。如果需要通過變更來糾正錯誤，應(yīng)保留原始記錄連同識別進(jìn)行糾正的人員身份的內(nèi)容，日

56、期及糾正的原因。3.2.5In order to verify paper records of GXP activities, the company shall establish and maintain Signature and Initial Logs for employees that work in GXP areas that include a handwritten specimen of the signature/initials of each employee. Employees must sign or initial original records in

57、 a contemporaneous manner, and must enter the date (and time if required by procedure) to accurately reflect who performed or witnessed the activity or who entered results or verified the accuracy of entries. Employees shall never record the signature or initials of another person or pre-date or bac

58、k date entries on any record (either paper or electronic).為了確認(rèn)紙質(zhì)記錄的GXP 活動，公司需建立并保存在GXP領(lǐng)域工作的員工簽名與初始日志，包括每個員工簽名/首字母的手寫樣本。員工必須以同步的方式在原始記錄上簽字或簽首字母，且必須注明日期(如果規(guī)程要求還需要注明時間)以準(zhǔn)確地反映誰實(shí)施或見證了該活動，或誰輸入結(jié)果或確認(rèn)輸入內(nèi)容的準(zhǔn)確性。員工不應(yīng)在記錄上簽其他人的簽名或首字母，或?qū)⑷掌谔崆盎蛲虾?紙質(zhì)或電子)。3.2.6The company shall maintain readily available records for a

59、n authorized inspection by regulatory authorities. The company shall provide access to all records that are required by applicable laws, regulations or legislative directives for GXP activities upon request by a duly authorized regulatory official who has the legal authority to inspect such records. Employees shall not delay, deny or limit access to records or refuse to permit inspection by