7月7日，歐盟委員會(huì)和PIC/S均發(fā)布了新的GMP修訂：包括正文第4章《文件記錄》、附錄11《計(jì)算機(jī)化系統(tǒng)》和一個(gè)新的附錄——附錄22《人工智能》，如下：

附錄11《計(jì)算機(jī)化系統(tǒng)》已翻譯完成，詳見新版歐盟/PIC/S GMP附錄11《計(jì)算機(jī)化系統(tǒng)》（中英文對照）

第四章 文件記錄 翻譯 如下：

Chapter 4: Documentation

第四章：文件記錄
Document map文件目錄
Principle原則

Data governance systems數(shù)據(jù)治理系統(tǒng)

Risk management風(fēng)險(xiǎn)管理

General requirements for documentation文件記錄的一般要求

Master Documents主文件

Generation and Control of Documentation文件記錄的生成與控制

Good documentation practice良好文件記錄規(guī)范

Signatures in GMP relevant documentationGMP 相關(guān)文件中的簽名

Retention of documents文件保存

Data Integrity in documentation文件記錄中的數(shù)據(jù)完整性

Hybrid Systems混合系統(tǒng)

Glossary術(shù)語

 

PRINCIPLE
原則

4.1 Documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents and means used should be fully understood and defined in the regulated user's pharmaceutical quality system.
4.1 文件記錄是質(zhì)量保證體系的重要組成部分，也是符合GMP要求運(yùn)營的關(guān)鍵。受監(jiān)管用戶的藥品質(zhì)量體系中應(yīng)充分理解和定義所使用的各類文件和方式。

4.2 It should be determined by the regulated user which legal provisions apply to documentation considering new technologies, hybrid solutions and services used.
4.2 受監(jiān)管用戶應(yīng)考慮所使用的新技術(shù)、混合解決方案和服務(wù)，確定哪些法律規(guī)定適用于文件記錄。

4.3 Appropriate documentation practices should be applied with respect to the type of document regardless of the applied technology or service used.
4.3 應(yīng)根據(jù)文件類型采用適當(dāng)?shù)奈募涗涀龇ǎ瑹o論所應(yīng)用的技術(shù)或服務(wù)如何。

4.4 The present document was supplemented with requirements regarding new technologies, hybrid solutions and new services, whereby a risk - based approach as element of a data governance system is considered pivotal for scalability of control measures.
4.4 本文件補(bǔ)充了關(guān)于新技術(shù)、混合解決方案和新服務(wù)的要求，其中基于風(fēng)險(xiǎn)的方法作為數(shù)據(jù)治理系統(tǒng)的要素，被認(rèn)為對控制措施的可擴(kuò)展性至關(guān)重要。

4.5 Quality risk management principles should be applied to ensure that the pharmaceutical quality system includes sufficient instructional details. It should facilitate a common understanding of the requirements. In addition to providing for recording of the various processes and risk - based evaluation of any observations, it should demonstrate the onerous application of all requirements.
4.5 應(yīng)使用質(zhì)量風(fēng)險(xiǎn)管理原則，以確保藥品質(zhì)量體系包含足夠的指導(dǎo)性細(xì)節(jié)。它應(yīng)有助于對要求形成共同理解。除了記錄各種過程和對任何觀察結(jié)果進(jìn)行基于風(fēng)險(xiǎn)的評估外，還應(yīng)證明所有要求都得到了嚴(yán)格應(yīng)用。

4.6 Suitable controls should be implemented using a risk - based approach to ensure the accuracy, integrity, availability, and legibility of documents. Documents should be free from errors and available in human - readable form.
4.6 應(yīng)采用基于風(fēng)險(xiǎn)的方法實(shí)施適當(dāng)?shù)目刂拼胧源_保文件的準(zhǔn)確性、完整性、可用性和易讀性。文件應(yīng)無錯(cuò)誤且以人類可讀的形式提供。

4.7 Documentation may exist in a variety of forms, including paper - based, electronic, or other means (e.g., photography; imagery, video, and audio recordings). The main objective of the documentation system is to establish, control, monitor and record all activities which directly or indirectly impact on all aspects of the quality and safety of medicinal products, using a risk - based approach.
4.7 文件記錄可能以多種形式存在，包括紙質(zhì)、電子或其他方式（例如，攝影；圖像、視頻和音頻記錄）。文件記錄系統(tǒng)的主要目標(biāo)是使用基于風(fēng)險(xiǎn)的方法，建立、控制、監(jiān)測和記錄直接或間接影響藥品質(zhì)量和安全各個(gè)方面的所有活動(dòng)。

4.8 Whether documents are created, stored, and managed electronically, paper - based, by other means or through a hybrid system, they must meet the same GMP requirements for legibility, accuracy, integrity, and completeness throughout the whole lifecycle. This also applies when documentation is outsourced.
4.8 無論文件是以電子方式、紙質(zhì)方式、其他方式還是通過混合系統(tǒng)創(chuàng)建、存儲(chǔ)和管理，它們在整個(gè)生命周期內(nèi)都必須滿足相同的GMP 要求，即易讀性、準(zhǔn)確性、完整性和完整性。這在外包文件記錄時(shí)同樣適用。

4.9 There are two primary types of documentation used to manage and demonstrate GMP compliance:
4.9 有兩種主要類型的文件記錄用于管理和證明符合GMP 要求：

i. instructions (directions, requirements) and
i. 指令（說明、要求）和

ii. records/reports.
ii. 記錄/ 報(bào)告。

 

DATA GOVERNANCE SYSTEMS
數(shù)據(jù)治理系統(tǒng)

4.10 Regardless of how documents are created, handled, stored, and managed (i.e., using electronic, paper - based, or hybrid systems), the regulated user should establish a data governance system integral to the pharmaceutical quality system to define, prioritise and communicate their data integrity risk management activities. Arrangements for data governance should be documented and reviewed regularly.
4.10 無論文件是如何創(chuàng)建、處理、存儲(chǔ)和管理的（即使用電子、紙質(zhì)或混合系統(tǒng)），受監(jiān)管用戶都應(yīng)建立一個(gè)與藥品質(zhì)量體系相結(jié)合的數(shù)據(jù)治理系統(tǒng)，以定義、確定優(yōu)先級(jí)并傳達(dá)其數(shù)據(jù)完整性風(fēng)險(xiǎn)管理活動(dòng)。應(yīng)有書面的數(shù)據(jù)治理安排并定期審查。

4.11 Regulated users should design and operate a data governance system which provides an acceptable state of control based on the risk assessment, which is documented with supporting rationale. A data governance system should be consistent with the principles of quality risk management.
4.11 受監(jiān)管用戶應(yīng)設(shè)計(jì)和運(yùn)行一個(gè)數(shù)據(jù)治理系統(tǒng)，該系統(tǒng)基于風(fēng)險(xiǎn)評估提供可接受的控制狀態(tài)，并記錄有支持性理由。數(shù)據(jù)治理系統(tǒng)應(yīng)符合質(zhì)量風(fēng)險(xiǎn)管理原則。

4.12 To ensure integrity of data the governance system should cover the entire data lifecycle and ensure controls to communicate with the principle of quality risk management. The data lifecycle should refer to:
4.12 為確保數(shù)據(jù)完整性，治理系統(tǒng)應(yīng)涵蓋整個(gè)數(shù)據(jù)生命周期，并確保控制措施與質(zhì)量風(fēng)險(xiǎn)管理原則相一致。數(shù)據(jù)生命周期應(yīng)涉及：

i. Creation and recording of data.
i. 數(shù)據(jù)的創(chuàng)建和記錄。

ii. Processing (raw) data to reported (derived) data.
ii. 將（原始）數(shù)據(jù)處理為報(bào)告（派生）數(shù)據(jù)。

iii. Verification of completeness, consistency and accuracy of all data (raw and derived data). For derived data the traceability which allows reconstruction of all data - processing activities should be maintained.
iii. 驗(yàn)證所有數(shù)據(jù)（原始數(shù)據(jù)和衍生數(shù)據(jù)）的完整性、一致性和準(zhǔn)確性。對于衍生數(shù)據(jù)，應(yīng)保持可追溯性，以便能夠重現(xiàn)所有數(shù)據(jù)處理活動(dòng)。

iv. Decision making relying on data (or derived data).
iv. 基于數(shù)據(jù)（或衍生數(shù)據(jù)）進(jìn)行決策。

v. Retaining, archiving and retrieval of data. To protect it from loss or unauthorised al - teration, it should be commensurate with the principles of quality risk management.
v. 數(shù)據(jù)的保留、存檔和檢索。為防止數(shù)據(jù)丟失或未經(jīng)授權(quán)的更改，其操作應(yīng)符合質(zhì)量風(fēng)險(xiǎn)管理原則。

vi. Retirement or destruction of data at the end of the life - cycle in a controlled manner.
vi. 在生命周期結(jié)束時(shí)，以受控方式停用或銷毀數(shù)據(jù)。

4.13 Data governance systems should rely on a risk management approach and consider:
4.13 數(shù)據(jù)治理系統(tǒng)應(yīng)依賴風(fēng)險(xiǎn)管理方法，并考慮：

i. Data criticality (impact to decision making and product quality).
i. 數(shù)據(jù)關(guān)鍵性（對決策制定和產(chǎn)品質(zhì)量的影響）。

ii. Data risk (opportunity for data alteration and deletion, and likelihood of detection /visibility of changes by the regular user's routine review processes).
ii. 數(shù)據(jù)風(fēng)險(xiǎn)（數(shù)據(jù)被更改和刪除的可能性，以及常規(guī)用戶日常審查流程檢測到/ 發(fā)現(xiàn)更改的可能性）。

4.14 Data governance systems should rely on the incorporation of well - designed systems, the use of technologies and security measures, combined with specific expertise to ensure that data integrity is effectively controlled over the data life - cycle.
4.14 數(shù)據(jù)治理系統(tǒng)應(yīng)依靠設(shè)計(jì)良好的系統(tǒng)、技術(shù)和安全措施的結(jié)合，并輔以特定的專業(yè)知識(shí)，以確保在數(shù)據(jù)生命周期內(nèi)有效控制數(shù)據(jù)完整性。

4.15 Data governance systems should address data ownership throughout the entire life - cycle.
4.15 數(shù)據(jù)治理系統(tǒng)應(yīng)在整個(gè)生命周期內(nèi)明確數(shù)據(jù)所有權(quán)。

4.16 Data governance systems should consider the design, operation and monitoring of processes and systems to comply with the principles of integrity.
4.16 數(shù)據(jù)治理系統(tǒng)應(yīng)考慮流程和系統(tǒng)的設(shè)計(jì)、運(yùn)行和監(jiān)控，以符合完整性原則。

4.17 Data governance systems should consider risk mitigation. The effectiveness of risk mitigation measures should be reviewed regularly, regardless of whether they are temporary or perma - nent. Residual risks should be reviewed periodically and communicated to management.
4.17 數(shù)據(jù)治理系統(tǒng)應(yīng)考慮風(fēng)險(xiǎn)緩解措施。無論風(fēng)險(xiǎn)緩解措施是臨時(shí)的還是永久的，都應(yīng)定期審查其有效性。應(yīng)定期審查殘余風(fēng)險(xiǎn)并向管理層報(bào)告。

4.18 Data governance systems should consider and ensure the periodic review of service provider's data management policies and risk control strategies intended to minimise potential risks to data integrity. The frequency of such reviews should be based on the criticality of the services provided, using risk management principles.
4.18 數(shù)據(jù)治理系統(tǒng)應(yīng)考慮并確保定期審查服務(wù)提供商的數(shù)據(jù)管理政策和風(fēng)險(xiǎn)控制策略，以盡量減少數(shù)據(jù)完整性的潛在風(fēng)險(xiǎn)。此類審查的頻率應(yīng)根據(jù)所提供服務(wù)的關(guān)鍵性，運(yùn)用風(fēng)險(xiǎn)管理原則來確定。

 

RISK MANAGEMENT
風(fēng)險(xiǎn)管理

4.19 The regulated user should adopt a risk - based approach in documentation throughout the entire life - cycle of data, regardless of the technology, hybrid solution or service used and should demonstrate an understanding of data criticality, data risk and data quality.
4.19 受監(jiān)管的用戶應(yīng)在數(shù)據(jù)的整個(gè)生命周期內(nèi)，無論使用何種技術(shù)、混合解決方案或服務(wù)，都采用基于風(fēng)險(xiǎn)的方法進(jìn)行記錄，并應(yīng)證明對數(shù)據(jù)關(guān)鍵性、數(shù)據(jù)風(fēng)險(xiǎn)和數(shù)據(jù)質(zhì)量的理解。

4.20 Controls over data life - cycle should be established which are commensurate with the prin - ciples of quality risk management. The depth of data governance and risk management activ - ities should be justified and commensurate with the risks to product quality and patient safety.
4.20 應(yīng)建立與質(zhì)量風(fēng)險(xiǎn)管理原則相符的數(shù)據(jù)生命周期控制措施。數(shù)據(jù)治理和風(fēng)險(xiǎn)管理活動(dòng)的深度應(yīng)合理，并與對產(chǎn)品質(zhì)量和患者安全的風(fēng)險(xiǎn)相稱。

4.21 Decisions on the extent of measures to ensure data integrity should be based on a documented rationale and documented risk assessment taking into consideration data criticality and data risk.
4.21 確保數(shù)據(jù)完整性的措施范圍的決策應(yīng)基于有記錄的理由和記錄的風(fēng)險(xiǎn)評估，并考慮數(shù)據(jù)關(guān)鍵性和數(shù)據(jù)風(fēng)險(xiǎn)。

4.22 Irrespective of processes used to generate electronic data, they must be included in the re - quirements for the qualification or validation of the relevant computerised systems according to Annex 11.
4.22 無論用于生成電子數(shù)據(jù)的過程如何，都必須根據(jù)附錄11 將其納入相關(guān)計(jì)算機(jī)化系統(tǒng)的確認(rèn)或驗(yàn)證要求中。

 

GENERAL REQUIREMENTS FOR DOCUMENTATION
文件記錄的一般要求

4.23 The pharmaceutical quality system should describe all documents required to ensure product quality and patient safety. Documents maybe created, recorded, provided, approved, commu - nicated, stored, and archived electronically, paper - based or in a hybrid system. The reliance on electronic, paper - based or different means, hybrid solutions with hosted services in main - tenance and retention of documentation requires the compliance with all EU GMP provisions including Annex 11 if decision making in manufacturing (e.g. batch release based on in - pro - cess controls and process analytical technologies) is supported by automatic validation scripts.
4.23 藥品質(zhì)量體系應(yīng)描述確保產(chǎn)品質(zhì)量和患者安全所需的所有文件。文件可以以電子、紙質(zhì)或混合系統(tǒng)的形式創(chuàng)建、記錄、提供、批準(zhǔn)、傳達(dá)、存儲(chǔ)和存檔。在制造過程中的決策（例如，基于過程控制和過程分析技術(shù)的批次放行）由自動(dòng)驗(yàn)證腳本支持的情況下，在文件的維護(hù)和保留方面依賴電子、紙質(zhì)或不同方式、托管服務(wù)的混合解決方案，需要符合所有歐盟GMP規(guī)定，包括附錄11。

4.24The accountability for the integrity of documents, records or (raw)data produced or processed with artificial intelligence or any other automatic means (e.g. validation scripts) rests with the regulated user.4.24 對于使用人工智能或任何其他自動(dòng)手段（例如驗(yàn)證腳本）生成或處理的文件、記錄或（原始）數(shù)據(jù)的完整性，責(zé)任在于受監(jiān)管用戶。

4.25. The support by any automatic means (e.g. validation scripts or artificial intelligence) should be included in a pharmaceutical quality system regardless of the service located on premise or as a hosted service.
任何自動(dòng)手段（例如驗(yàn)證腳本或人工智能）的支持都應(yīng)納入藥品質(zhì)量體系，無論該服務(wù)是本地服務(wù)還是托管服務(wù)。

The records created electronically should enable a trend analysis of quality - critical data.
電子創(chuàng)建的記錄應(yīng)能夠?qū)|(zhì)量關(guān)鍵數(shù)據(jù)進(jìn)行趨勢分析。

4.26. To ensure data integrity, data which is recorded or processed electronically should not be converted to or stored in a paper form unless it meets the requirements set out in section 13 “hybrid systems” or the conversion is validated or verified for accuracy.
為確保數(shù)據(jù)完整性，以電子方式記錄或處理的數(shù)據(jù)不應(yīng)轉(zhuǎn)換為紙質(zhì)形式或存儲(chǔ)在紙質(zhì)介質(zhì)中，除非其符合第13 節(jié)“混合系統(tǒng)” 中規(guī)定的要求，或者轉(zhuǎn)換已針對準(zhǔn)確性進(jìn)行了驗(yàn)證或核實(shí)。

 

MASTER DOCUMENTS
主文件

4.27. Specifically required master documents (not exhaustive list):
4.27. 特別要求的主文件（非詳盡列表）：

i. Site Master File: Refer to EU GMP Guidelines, Volume 4 “Explanatory Notes on the preparation of a Site Master File”.
i. 場地主文件：參考?xì)W盟GMP 指南，第4 卷“場地主文件編制解釋說明”。

ii. Validation Master Plan: A document describing the key elements of the site qualification and validation program. Master documents should be evaluated and reviewed on a regular basis.
ii. 驗(yàn)證主計(jì)劃：一份描述場地確認(rèn)和驗(yàn)證計(jì)劃關(guān)鍵要素的文件。主文件應(yīng)定期進(jìn)行評估和審核。

iii. Instruction (directions, or requirements) type:
iii. 指令（指示或要求）類型：

——Specification: Refer to glossary for definition
質(zhì)量標(biāo)準(zhǔn)：定義見術(shù)語表

——Manufacturing Formulae, Processing, Packaging and Testing Instruction: Provide complete detail on all the starting materials, equipment, and computerised systems (if any) to be used and specify all processing, packaging, sampling, and testing instructions to ensure batch to batch consistency. In - process controls and relevant analytical techniques to be employed should be specified where relevant, together with acceptance criteria.
制造配方、加工、包裝和測試指令：提供所有將使用的起始物料、設(shè)備和計(jì)算機(jī)化系統(tǒng)（如有）的完整詳細(xì)信息，并指定所有加工、包裝、取樣和測試指令，以確保批次間的一致性。應(yīng)在相關(guān)情況下指定要采用的過程控制和相關(guān)分析技術(shù)以及驗(yàn)收標(biāo)準(zhǔn)。

——Procedures: (Otherwise known as Standard Operating Procedures, or SOPs), documented set of instructions for performing and recording operations.
規(guī)程：（也稱為標(biāo)準(zhǔn)操作規(guī)程，即SOP），執(zhí)行和記錄操作的文件化指令集。

——Protocol: defined set of activities to provide instructions for performing and recording certain discreet operations.
方案：為執(zhí)行和記錄某些特定操作提供指令的一組定義的活動(dòng)。

——Technical / Quality Agreement: Written proof of agreement between contract givers and acceptors for outsourced activities.
技術(shù)/ 質(zhì)量協(xié)議：外包活動(dòng)中合同授予方和接受方之間協(xié)議的書面證明。

iv. Record/Report type:
iv. 記錄/ 報(bào)告類型：

——Record: Provide evidence of various actions taken to demonstrate compliance with instructions, e.g. activities, events, investigations, and in the case of manufactured batches a history of each batch of product, including its distribution. Records include the raw data which is used to generate other records. For electronic records regulated users should define which data are to be used as raw data. At least, all data on which quality decisions are based should be defined as raw data.
記錄：提供為證明符合指令而采取的各種行動(dòng)的證據(jù)，例如活動(dòng)、事件、調(diào)查，對于生產(chǎn)批次，還包括每批產(chǎn)品的歷史記錄，包括其分銷情況。記錄包括用于生成其他記錄的原始數(shù)據(jù)。對于受監(jiān)管的電子記錄用戶，應(yīng)定義哪些數(shù)據(jù)將用作原始數(shù)據(jù)。至少，所有作為質(zhì)量決策依據(jù)的數(shù)據(jù)都應(yīng)定義為原始數(shù)據(jù)。

——Certificate of Analysis: Provide a summary of testing results on samples of products or materials' together with the evaluation for compliance to a stated specification.
分析證書：提供產(chǎn)品或材料樣品測試結(jié)果的摘要，以及對是否符合規(guī)定規(guī)格的評估。

——Report: Document the conduct of exercises, studies, assessments, projects or investigations, together with results, conclusions and recommendations.
報(bào)告：記錄演習(xí)、研究、評估、項(xiàng)目或調(diào)查的開展情況，以及結(jié)果、結(jié)論和建議。

Specifications
質(zhì)量標(biāo)準(zhǔn)

4.28. There should be approved and updated specifications for starting and packaging materials, intermediate, bulk, finished products, process aids and other quality critical material, as applicable. Specifications should include all attributes which are relevant for product quality on each stage of material or manufacture.
4.28. 對于起始物料和包裝材料、中間體、待包裝產(chǎn)品、成品、工藝助劑及其他關(guān)鍵質(zhì)量物料（如適用），應(yīng)有經(jīng)批準(zhǔn)且更新的質(zhì)量標(biāo)準(zhǔn)。質(zhì)量標(biāo)準(zhǔn)應(yīng)包括物料或生產(chǎn)各階段與產(chǎn)品質(zhì)量相關(guān)的所有屬性。

Specifications for starting and packaging materials
起始物料和包裝材料的質(zhì)量標(biāo)準(zhǔn)

4.29. Specifications for starting and primary or printed packaging materials should include the product and its reference code, if applicable;
4.29. 起始物料和主要或印刷包裝材料的質(zhì)量標(biāo)準(zhǔn)應(yīng)包括產(chǎn)品及其參考代碼（如適用）；

i. A description of the materials, including:
i. 物料描述，包括：

The designated name and the internal code reference.
指定名稱和內(nèi)部代碼參考。      The reference, if any, to a pharmacopoeial monograph.
 藥典專論的參考（如有）。      The approved supplier, and, if applicable, the original producer of the material.
 經(jīng)批準(zhǔn)的供應(yīng)商，以及（如適用）物料的原始生產(chǎn)商。      A specimen of printed materials.
印刷材料樣本。

ii. Directions for sampling and testing.
ii. 取樣和測試說明。

iii. Qualitative and quantitative requirements with acceptance limits.
iii. 帶有可接受限度的定性和定量要求。

iv. Storage conditions and precautions.
iv. 儲(chǔ)存條件和預(yù)防措施。

v. The maximum period of storage before re - examination.
v. 重新檢驗(yàn)前的最長儲(chǔ)存期限。

Specifications for intermediate and bulk products
中間體和待包裝產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)

4.30. Specifications for intermediate and bulk products should be available for critical steps or if these are purchased or dispatched. The specifications should be similar to specifications for starting materials or for finished products, as appropriate.
4.30. 對于關(guān)鍵步驟的中間體和待包裝產(chǎn)品，或在采購或發(fā)運(yùn)時(shí)，應(yīng)有質(zhì)量標(biāo)準(zhǔn)。這些質(zhì)量標(biāo)準(zhǔn)應(yīng)根據(jù)情況類似于起始物料或成品的質(zhì)量標(biāo)準(zhǔn)。

Specifications for finished products
成品的質(zhì)量標(biāo)準(zhǔn)

4.31. Specifications for finished products should include or provide reference to:
4.31. 成品的質(zhì)量標(biāo)準(zhǔn)應(yīng)包括或提及：

vi. The designated name of the product and the code reference where applicable.
vi. 產(chǎn)品的指定名稱及適用的代碼參考。

vii. The formula.
vii. 配方。

viii. A description of the pharmaceutical form and package details.
viii. 劑型和包裝細(xì)節(jié)描述。

ix. Directions for sampling and testing.
ix. 取樣和測試說明。

x. The qualitative and quantitative requirements, with the acceptance limits.
x. 帶有可接受限度的定性和定量要求。

xi. The storage conditions and any special handling precautions, where applicable.
xi. 儲(chǔ)存條件和任何特殊處理預(yù)防措施（如適用）。

xii. The shelf - life.
xii. 保質(zhì)期。

Manufacturing Formula and Processing Instructions
生產(chǎn)配方和工藝規(guī)程

4.32. Approved, written Manufacturing Formula and Processing Instructions should exist for each product and batch size to be manufactured.
4.32. 對于每個(gè)要生產(chǎn)的產(chǎn)品和批次規(guī)模，應(yīng)有經(jīng)批準(zhǔn)的書面生產(chǎn)配方和工藝規(guī)程。

4.33. The Manufacturing Formula should include:
4.33. 生產(chǎn)配方應(yīng)包括：

i. The name of the product, with a product reference code relating to its specification.
i. 產(chǎn)品名稱，以及與其規(guī)格相關(guān)的產(chǎn)品參考代碼。

ii. A description of the pharmaceutical form, strength of the product and batch size.
ii. 劑型、產(chǎn)品規(guī)格和批量的描述。

iii. A list of all starting materials to be used, with the amount of each, described;
iii. 所用所有起始物料的清單，并注明每種物料的用量；

mention should be made of any substance that may disappear while processing, of processing aids needed or any other material relevant for product quality.
應(yīng)提及在加工過程中可能消失的任何物質(zhì)、所需的加工助劑或與產(chǎn)品質(zhì)量相關(guān)的任何其他材料。

iv. A statement of the expected final yield with the acceptable limits, and of relevant in - termediate yields, where applicable.
iv. 預(yù)期最終產(chǎn)量及其可接受限度的說明，以及適用時(shí)相關(guān)中間產(chǎn)量的說明。

4.34. The Processing Instructions should include:
4.34. 工藝規(guī)程應(yīng)包括：

i. A statement of the processing location and the principal equipment to be used.
i. 所用加工地點(diǎn)和主要設(shè)備的說明。

ii. The methods, or reference to the methods, to be used for preparing the critical equipment (e.g. cleaning, assembling, calibrating, sterilising).
ii. 用于準(zhǔn)備關(guān)鍵設(shè)備的方法，或?qū)@些方法的引用（如清潔、組裝、校準(zhǔn)、滅菌）。

iii. Checks that the equipment and workstation are clear of previous products, documents or materials not required for the planned process, and that equipment is clean and suitable for use.
iii. 檢查設(shè)備和工作站是否無先前產(chǎn)品、計(jì)劃工藝不需要的文件或材料，且設(shè)備清潔并適合使用。

iv. Detailed step - wise processing instructions [e.g. checks on materials, pre - treatments, sequence for adding materials, critical process parameters (time, temp etc)].
iv. 詳細(xì)的分步加工說明[如物料檢查、預(yù)處理、添加物料的順序、關(guān)鍵工藝參數(shù)（時(shí)間、溫度等）]。

v. The instructions for any in - process controls with their limits.
v. 任何過程控制及其限度的說明。

vi. Where necessary, the requirements for bulk storage of the products; including the container, labelling and special storage conditions where applicable.
vi. 必要時(shí)，產(chǎn)品批量儲(chǔ)存的要求；包括容器、標(biāo)簽以及適用時(shí)的特殊儲(chǔ)存條件。

vii. Any special precautions to be observed.
vii. 需遵守的任何特殊預(yù)防措施。

Packaging Instructions
包裝規(guī)程

4.35. Approved Packaging Instructions for each product, pack size and type should exist. These should include, or have a reference to, the following:
4.35. 每種產(chǎn)品、包裝尺寸和類型都應(yīng)有經(jīng)批準(zhǔn)的包裝規(guī)程。這些規(guī)程應(yīng)包括或引用以下內(nèi)容：

i. Name of the product; including the batch number of bulk and finished product.
i. 產(chǎn)品名稱；包括散裝和成品的批號(hào)。

ii. Description of its pharmaceutical form, and strength where applicable.
ii. 其藥物形式的描述，以及適用時(shí)的規(guī)格。

iii. The pack size expressed in terms of the number, weight or volume of the product in the final container.
iii. 以最終容器中產(chǎn)品的數(shù)量、重量或體積表示的包裝尺寸。

iv. A complete list of all the packaging materials required, including quantities, sizes and types, with the code or reference number relating to the specifications of each packaging material.
iv. 所需所有包裝材料的完整清單，包括數(shù)量、尺寸和類型，以及與每種包裝材料規(guī)格相關(guān)的代碼或參考編號(hào)。

v. Where appropriate, an example or reproduction of the relevant printed packaging materials, and specimens indicating where to apply batch number references, and shelf life of the product.
v. 適當(dāng)時(shí)，相關(guān)印刷包裝材料的示例或復(fù)制品，以及標(biāo)明批號(hào)引用位置和產(chǎn)品保質(zhì)期的樣本。

vi. Checks that the equipment and workstation are clear of previous products, documents or materials not required for the planned packaging operations (line clear - ance), and that equipment is clean and suitable for use.
vi. 檢查設(shè)備和工作站是否無先前產(chǎn)品、計(jì)劃包裝操作不需要的文件或材料（生產(chǎn)線清潔），且設(shè)備清潔并適合使用。

vii. Checks on functioning of any electronic code readers, label counters or similar devices.
vii. 檢查任何電子讀碼器、標(biāo)簽計(jì)數(shù)器或類似設(shè)備的功能。

viii. Special precautions to be observed, including a careful examination of the area and equipment in order to ascertain the line clearance before operations begin.
viii. 需遵守的特殊預(yù)防措施，包括在操作開始前仔細(xì)檢查區(qū)域和設(shè)備以確定生產(chǎn)線清潔。

ix. A description of the packaging operation, including any significant subsidiary operations, and equipment to be used.
ix. 包裝操作的描述，包括任何重要的輔助操作以及要使用的設(shè)備。

x. Details of in - process controls with instructions for sampling and acceptance limits.
x. 過程控制的詳細(xì)信息，包括取樣和驗(yàn)收限度的說明。

Batch Processing Record
批生產(chǎn)記錄

4.36. A Batch Processing Record should be kept for each batch processed. It should be based on the relevant parts of the currently approved Manufacturing Formula and Processing Instructions, and should contain the following information.
4.36. 每批加工產(chǎn)品都應(yīng)保存批次加工記錄。該記錄應(yīng)基于當(dāng)前已批準(zhǔn)的生產(chǎn)配方和工藝規(guī)程的相關(guān)部分，并應(yīng)包含以下信息。

i. The name and batch number of the product.
i. 產(chǎn)品名稱和批號(hào)。

ii. Dates and times of commencement, of significant intermediate stages and of completion of production.
ii. 生產(chǎn)開始、重要中間階段和完成的日期和時(shí)間。

iii. Identification (initials) of the operator (s) who performed each significant step of the process and, where appropriate, identification (initials) of the person who checked these operations.
iii. 執(zhí)行該過程每個(gè)重要步驟的操作人員的標(biāo)識(shí)（姓名首字母），并在適當(dāng)情況下，對這些操作進(jìn)行檢查的人員的標(biāo)識(shí)（姓名首字母）。

iv. The batch number and/or analytical control number as well as the quantities of each starting material weighed (including the batch number and amount of any recovered or reprocessed material added).
iv. 批號(hào)和/ 或分析控制編號(hào)，以及每種起始物料的稱重?cái)?shù)量（包括任何回收或再加工物料的批號(hào)和添加量）。

v. Any relevant processing operation or event and major equipment used.
v. 任何相關(guān)的加工操作或事件以及使用的主要設(shè)備。

vi. A record of the in - process controls and the initials of the person (s) carrying them out, and the results obtained.
vi. 過程控制記錄以及執(zhí)行控制人員的姓名首字母，以及所獲得的結(jié)果。

vii. The product yields obtained at different and pertinent stages of manufacture.
vii. 在不同且相關(guān)的生產(chǎn)階段獲得的產(chǎn)品收率。

viii. Notes on special problems including details, with signed authorization for any deviation from the Manufacturing Formula and Processing Instructions.
viii. 關(guān)于特殊問題的說明，包括詳細(xì)信息，以及對任何偏離生產(chǎn)配方和工藝規(guī)程的簽署授權(quán)。

ix. Approval by the person responsible for the processing operations.
ix. 由負(fù)責(zé)加工操作的人員批準(zhǔn)。

Note: Where a validated process is continuously monitored and controlled, then automatically generated reports may be limited to compliance summaries and exception/out - of - specification (OOS) data reports.
注意：如果經(jīng)過驗(yàn)證的過程受到持續(xù)監(jiān)控和控制，則自動(dòng)生成的報(bào)告可能僅限于合規(guī)性總結(jié)以及異常/ OOS數(shù)據(jù)報(bào)告。

With regards to decision making in manufacturing supported by automatic validation scripts or artificial intelligence refer to paragraph 4 of this document.
關(guān)于由自動(dòng)驗(yàn)證腳本或人工智能支持的生產(chǎn)決策，請參閱本文件第4 段。

Batch Packaging Record
批包裝記錄

4.37. A Batch Packaging Record should be kept for each batch or part batch processed. It should be based on the relevant parts of the Packaging Instructions.
4.37. 應(yīng)對每個(gè)加工的批次或部分批次保存批次包裝記錄。該記錄應(yīng)基于包裝規(guī)程的相關(guān)部分。

4.38. The batch packaging record should contain the following information:
4.38. 批次包裝記錄應(yīng)包含以下信息：

i. The name and batch number of the product.
i. 產(chǎn)品名稱和批號(hào)。

ii. The date (s) and times of the packaging operations.
ii. 包裝操作的日期和時(shí)間。

iii. Identification (initials) of the operator (s) who performed each significant step of the process and, where appropriate, the name of any person who checked these operations.
iii. 執(zhí)行該過程每個(gè)重要步驟的操作人員的標(biāo)識(shí)（姓名首字母），并在適當(dāng)情況下，對這些操作進(jìn)行檢查的人員的姓名。

iv. Records of checks for identity and conformity with the packaging instructions, including the results of in - process controls.
iv. 對與包裝規(guī)程的一致性和相符性的檢查記錄，包括過程控制結(jié)果。

v. Records of checks that the equipment and workstation are clear of previous products, documents or materials not required for the planned packaging operations (line clearance), that equipment is clean and suitable for use, and that any electronic code readers, label counters or similar devices are functioning as expected.
v. 檢查記錄，確保設(shè)備和工作站無計(jì)劃包裝操作不需要的先前產(chǎn)品、文件或材料（清場），設(shè)備清潔且適合使用，并且任何電子掃碼器、標(biāo)簽計(jì)數(shù)器或類似設(shè)備按預(yù)期運(yùn)行。

vi. Details of the packaging operations carried out, including references to equipment and the packaging lines used.
vi. 所進(jìn)行的包裝操作的詳細(xì)信息，包括對所用設(shè)備和包裝生產(chǎn)線的參考。

vii. Whenever possible, samples of printed packaging materials used, including specifications of the batch coding, expiry dating and any additional overprinting.
vii. 只要可能，所用印刷包裝材料的樣品，包括批次編碼、有效期和任何額外套印的規(guī)格。

viii. Notes on any special problems or unusual events including details, with signed authorization for any deviation from the packaging instructions.
viii. 關(guān)于任何特殊問題或異常事件的說明，包括詳細(xì)信息，以及對任何偏離包裝規(guī)程的簽署授權(quán)。

ix. The quantities and reference number or identification of all printed packaging materials and bulk product issued, used, destroyed or returned to stock and the quantities of obtained product, to provide for an adequate reconciliation. Where there are vali - dated electronic controls in place during packaging there may be justification for not including this information.
ix. 所有已發(fā)放、使用、銷毀或退回庫存的印刷包裝材料和散裝產(chǎn)品的數(shù)量、參考編號(hào)或標(biāo)識(shí)，以及所獲得產(chǎn)品的數(shù)量，以便進(jìn)行充分的核對。在包裝過程中如果有經(jīng)過驗(yàn)證的電子控制，可能有理由不包含此信息。

x. Approval by the person responsible for the packaging operations.
x. 由負(fù)責(zé)包裝操作的人員批準(zhǔn)。

Receipt
接收

4.39. There should be written procedures and records for the receipt of each delivery of each starting material, (including bulk, intermediate or finished goods), primary, secondary and printed packaging materials and QC - samples. The records of the receipts should include:
4.39. 對于每批起始物料（包括散裝、中間體或成品）、內(nèi)包裝、外包裝和印刷包裝材料以及質(zhì)量控制樣品的接收，應(yīng)有書面程序和記錄。接收記錄應(yīng)包括：

i. The name of the material and the delivery notes and the containers.
i. 物料名稱、送貨單和容器。

ii. The “in - house” name or/and code of material (if different from a).
ii. 物料的“內(nèi)部” 名稱或/ 和代碼（如果與i 不同）。

iii. Date of receipt.
iii. 接收日期。

iv. Supplier’s name and, manufacturer’s name.
iv. 供應(yīng)商名稱和制造商名稱。

v. Manufacturer’s batch or reference number.
v. 制造商的批次或參考編號(hào)。

vi. Total quantity and number of containers received.
vi. 接收的總數(shù)量和容器數(shù)量。

vii. The batch number assigned after receipt.
vii. 接收后分配的批次號(hào)。

viii. Any relevant comment.
viii. 任何相關(guān)評論。

ix. If applicable, proof of verification that temperature during transportation were within the approved limit.
ix. 如適用，運(yùn)輸過程中溫度在批準(zhǔn)范圍內(nèi)的驗(yàn)證證據(jù)。

4.40. There should be written procedures for the internal labelling, quarantine and storage of start - ing materials, packaging materials, QC samples and other materials, as appropriate.
4.40. 應(yīng)有適當(dāng)?shù)臅娉绦颍糜谄鹗嘉锪稀b材料、質(zhì)量控制樣品和其他物料的內(nèi)部標(biāo)識(shí)、待檢和存儲(chǔ)。

Sampling
取樣

4.41. There should be written procedures for sampling, which include the methods and equipment to be used, the amounts to be taken and any precautions to be observed to avoid contamination of the material or any deterioration in its quality (reference to EU GMP Guideline Volume 4, Chapter 6 “Quality Control”).
4.41. 應(yīng)有書面的取樣程序，包括所使用的方法和設(shè)備、取樣量以及為避免物料污染或質(zhì)量下降而應(yīng)遵守的任何預(yù)防措施（參考EU GMP第4 卷，第6 章“質(zhì)量控制”）。

Testing
測試

4.42. There should be written procedures for testing materials and products at different stages of manufacture, describing the methods and equipment to be used. The tests performed should be recorded (reference to EU GMP Guideline Volume 4, Chapter 6 “Quality Control”).
4.42. 應(yīng)有書面程序，用于在生產(chǎn)的不同階段對物料和產(chǎn)品進(jìn)行測試，描述所使用的方法和設(shè)備。所進(jìn)行的測試應(yīng)記錄在案（參考EU GMP第4 卷，第6 章“質(zhì)量控制”）。

Other
其他

4.43. Written release and rejection procedures should be available for materials and products, and in particular for the certification for sale of the finished product by the Qualified Person (s). All records should be available to the Qualified Person at the time of the release decision. A system should be in place to indicate special observations and any changes to critical data.
4.43. 應(yīng)有物料和產(chǎn)品的書面放行和拒收程序，特別是由有資質(zhì)人員對成品銷售的認(rèn)證程序。在做出放行決定時(shí)，所有記錄應(yīng)可供有資質(zhì)人員查閱。應(yīng)建立一個(gè)系統(tǒng)，以表明特殊觀察結(jié)果和關(guān)鍵數(shù)據(jù)的任何變化。

4.44. Records should be maintained for the distribution of each batch of a product in order to facili - tate recall of any batch, if necessary.
4.44. 應(yīng)保存每批產(chǎn)品的分銷記錄，以便在必要時(shí)便于召回任何批次。

4.45. There should be written policies, procedures, protocols, reports and the associated records of actions taken, or conclusions reached, where appropriate, for GMP relevant actions, including but not limited to the following examples:
4.45. 對于與GMP相關(guān)的行動(dòng)，應(yīng)有書面政策、程序、方案、報(bào)告以及所采取行動(dòng)的相關(guān)記錄，或在適當(dāng)情況下達(dá)成的結(jié)論,包括但不限于以下示例：

i. Validation and qualification of processes, equipment and systems.
工藝、設(shè)備和系統(tǒng)的驗(yàn)證與確認(rèn)。

ii. Equipment assembly and calibration.
設(shè)備組裝與校準(zhǔn)。

iii. Data integrity.
數(shù)據(jù)完整性。

iv. Technology transfer.
技術(shù)轉(zhuǎn)移。

v. Maintenance, cleaning and sanitation.
維護(hù)、清潔與衛(wèi)生。

vi. Personnel matters including signature lists, training in GMP and technical matters, clothing and hygiene and verification of the effectiveness of training.
人員相關(guān)事宜，包括簽名清單、GMP 及技術(shù)事項(xiàng)培訓(xùn)、著裝與衛(wèi)生以及培訓(xùn)有效性的驗(yàn)證。

vii. Environmental monitoring.
環(huán)境監(jiān)測。

viii. Pest control.
蟲害控制。

ix. Complaints.
投訴。

x. Recalls.
召回。

xi. Returns.
退貨。

xii. Change control.
變更控制。

xiii. Investigations into deviations.
偏差調(diào)查。

xiv. non - conformances e.g. out of specifications.
不符合項(xiàng)，例如規(guī)格不符。

xv. Internal quality/GMP compliance audits.
內(nèi)部質(zhì)量/ GMP 合規(guī)審計(jì)。

xvi. Summaries of records where appropriate (e.g. product quality review).
適當(dāng)情況下的記錄匯總（如產(chǎn)品質(zhì)量回顧）。

xvii. Supplier audits.
供應(yīng)商審計(jì)。

4.46 Clear operating procedures should be available for all testing, manufacturing and test equipment.
4.46 對于所有檢測、生產(chǎn)和測試設(shè)備，都應(yīng)有清晰的操作規(guī)程。

4.47 Logbooks should be kept for major or critical analytical items, production equipment, and areas where product has been processed or handled. They should be used to record in chronological order, as appropriate, any use of the area, equipment/method, calibrations, maintenance, cleaning or repair operations, including the dates and identity of people who carried these operations out.
4.47 對于主要或關(guān)鍵的分析項(xiàng)目、生產(chǎn)設(shè)備以及產(chǎn)品加工或處理的區(qū)域，應(yīng)保存日志。日志應(yīng)按時(shí)間順序記錄該區(qū)域、設(shè)備/ 方法的使用情況、校準(zhǔn)、維護(hù)、清潔或維修操作，包括執(zhí)行這些操作的日期和人員身份。

4.48 An inventory of controls within the pharmaceutical quality system should be maintained.
4.48 應(yīng)維護(hù)藥品質(zhì)量體系內(nèi)的控制清單。

4.49 All types of documents (instructions and/or records) should be defined and adhered to regardless of the documentation technology, hybrid solution or service. The technology, hybrid solution or provided service needs to be understood regardless of complexity, should be adequately documented, and validated with risk - based controls in place. Relationships and control measures for master documents, official copies, data handling and records need to be defined for both hybrid and homogenous systems regardless of the type of service. Appropriate controls for documents should be implemented to ensure the completeness, integrity and legibility of the records throughout the lifecycle.
4.49 無論采用何種文件編制技術(shù)、混合解決方案或服務(wù)，所有類型的文件（規(guī)程和/ 或記錄）都應(yīng)明確并遵守。無論復(fù)雜程度如何，都應(yīng)了解所采用的技術(shù)、混合解決方案或提供的服務(wù)，應(yīng)進(jìn)行充分記錄，并通過基于風(fēng)險(xiǎn)的控制進(jìn)行驗(yàn)證。對于混合系統(tǒng)和同質(zhì)系統(tǒng)，無論服務(wù)類型如何，都應(yīng)定義主文件、正式副本、數(shù)據(jù)處理和記錄的關(guān)系及控制措施。應(yīng)實(shí)施適當(dāng)?shù)奈募刂疲源_保記錄在整個(gè)生命周期內(nèi)的完整性、準(zhǔn)確性和可讀性。

4.50. Documents should be designed, prepared, reviewed, and distributed in a controlled manner. They should comply with the relevant parts of Product Specification Files Manufacturing and Marketing Authorisation dossiers, or dossiersof Investigational Medicinal Products, as appropriate. The reproduction of working documents from master documents should not allow any error or alteration to be introdueed through the reproduction process.

4.50. 文件的設(shè)計(jì)、編制、審核和分發(fā)應(yīng)受到控制。它們應(yīng)酌情符合產(chǎn)品規(guī)格文件、生產(chǎn)和上市許可卷宗或研究用藥品卷宗的相關(guān)部分。從主文件復(fù)制工作文件時(shí)，不應(yīng)在復(fù)制過程中引入任何錯(cuò)誤或改動(dòng)。

4.5.1. Documents should be regularly reviewed and kept up - to - date. Documents should be approved, signed, and dated by appropriate and authorised personnel. Documents should have unambiguous contents and be uniquely identifiable. The effective date should be defined.
4.5.1. 文件應(yīng)定期審核并保持最新。文件應(yīng)由適當(dāng)且經(jīng)授權(quán)的人員批準(zhǔn)、簽署和注明日期。文件應(yīng)清晰明確、內(nèi)容無歧義且具有唯一性。應(yīng)定義生效日期。

4.5.2. Documents containing instructions should be laid out in an orderly fashion and be easy to review. The style and language of documents should fit with their intended use. Standard operating procedures, work instructions and methods should be written in an appropriate mandatory style by using pre - defined format. Data entry formats for completion of documents should be clearly defined. Written instructions may be supported with pictures, photos or videos. The documents containing the instructions should be easily accessible at the place where the described activities are carried out.
4.5.2. 包含規(guī)程的文件應(yīng)有序編排，且易于查閱。文件的風(fēng)格和語言應(yīng)符合其預(yù)期用途。標(biāo)準(zhǔn)操作程序、工作說明和方法應(yīng)采用標(biāo)準(zhǔn)格式編寫。應(yīng)使用預(yù)先定義的格式確定數(shù)據(jù)輸入要求。應(yīng)明確界定文件完成情況。書面說明可輔以圖片、照片或視頻。包含說明的文件應(yīng)在進(jìn)行所述活動(dòng)的地點(diǎn)易于獲取。

4.5.3. Instructions and procedures within the Quality Management System should be regularly reviewed and kept updated.
4.5.3. 質(zhì)量管理體系內(nèi)的規(guī)程和程序應(yīng)定期審核并保持最新。

4.5.4. The issuance, revision, superseding and withdrawal of all documents should be controlled with maintenance of revision histories.
4.5.4. 所有文件的發(fā)布、修訂、替代和撤回均應(yīng)受到控制，并保留修訂歷史記錄。

4.5.5. Where documents require the manual entry of data, sufficient space should be provided for such entries to ensure adequately clear and legible manual recording.
4.5.5. 對于需要手動(dòng)輸入數(shù)據(jù)的文件，應(yīng)提供足夠的空間，以確保輸入清晰、合法且手動(dòng)記錄。

 

GOOD DOCUMENTATION PRACTICE
良好文件記錄規(guī)范

4.56. Good Documentation practices are key to ensuring data integrity, and a fundamental part of a well - designed pharmaceutical quality system.
4.56. 良好的記錄規(guī)范是確保數(shù)據(jù)完整性的關(guān)鍵，也是精心設(shè)計(jì)的藥品質(zhì)量體系的基本組成部分。

4.57. Procedures defining good documentation practices and arrangements for document control should be available within the pharmaceutical quality system. Good documentation practices should be implemented and enforced to ensure data integrity.
4.57. 在藥品質(zhì)量體系中，應(yīng)具備定義良好記錄規(guī)范和文件控制安排的程序。良好記錄規(guī)范應(yīng)得到實(shí)施和執(zhí)行，以確保數(shù)據(jù)完整性。

4.58. Data entries should be accurate, and made in clear, legible, indelible way. Recorded media should be durable throughout the retention period. If this is not feasible, then true copies should be generated. For this a documented system should be in place to verify and record the integrity of a copy.
4.58. 數(shù)據(jù)錄入應(yīng)準(zhǔn)確，并以清晰、易讀、不可擦除的方式進(jìn)行。記錄介質(zhì)在整個(gè)保存期內(nèi)應(yīng)耐用。如果這不可行，則應(yīng)生成真實(shí)副本。為此，應(yīng)建立一個(gè)有文件記錄的系統(tǒng)，以驗(yàn)證和記錄副本的完整性。

4.59. Records should be made or completed at the time each action is taken and in such a way that all GMP activities are traceable. It should be possible to identify the individual or the system that performed the task and when the task was performed.
4.59. 記錄應(yīng)在每次采取行動(dòng)時(shí)進(jìn)行或完成，并且方式應(yīng)使所有GMP 活動(dòng)都可追溯。應(yīng)能夠識(shí)別執(zhí)行任務(wù)的個(gè)人或系統(tǒng)以及任務(wù)執(zhí)行的時(shí)間。

4.60. Any alteration made to the entry on a document should be signed by the individual who made the change and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.
4.60. 對文件錄入內(nèi)容的任何更改應(yīng)由進(jìn)行更改的個(gè)人簽字并注明日期；更改應(yīng)允許讀取原始信息。在適當(dāng)情況下，應(yīng)記錄更改的原因。

4.61. Records need to be a truthful and consistent representation of facts to ensure the accuracy of information, including data that is used to make critical decisions about the quality of products.
4.61. 記錄需要真實(shí)且一致地反映事實(shí)，以確保信息的準(zhǔn)確性，包括用于對產(chǎn)品質(zhì)量做出關(guān)鍵決策的數(shù)據(jù)。

4.62. Specific controls should be implemented to ensure the integrity of raw data and results recorded on paper. These may include, but are not limited to:
4.62. 應(yīng)實(shí)施特定控制措施，以確保紙質(zhì)記錄的原始數(shù)據(jù)和結(jié)果的完整性。這些措施可能包括但不限于：

i. control over the issuance and use of loose paper sheets (blank forms) at the time of recording data.
i. 在記錄數(shù)據(jù)時(shí)，對散頁紙（空白表格）的發(fā)放和使用進(jìn)行控制。

ii. control over the issuance and bound, paginated notebooks.
ii. 對裝訂成冊、編有頁碼的筆記本的發(fā)放進(jìn)行控制。

iii. control over the identification and reconciliation of sequentially numbered copies of  blank forms with authenticity controls.
iii. 對帶有真實(shí)性控制的按順序編號(hào)的空白表格副本的識(shí)別和核對進(jìn)行控制。

iv. Control that raw data is contemporaneously and accurately recorded by permanent means.

iv. 控制原始數(shù)據(jù)通過永久性方式及時(shí)且準(zhǔn)確地記錄。

4.63. Basic data integrity principles (table 1) applicable to both paper and electronic systems (i.e. ALCOA ++).

4.63. 適用于紙質(zhì)和電子系統(tǒng)的基本數(shù)據(jù)完整性原則（表1）（即ALCOA ++）。

Table 1: Data integrity principles
表1：數(shù)據(jù)完整性原則

 

 

SIGNATURES IN GMP RELEVANT DOCUMENTATIONGMP相關(guān)文件中的簽名

4.64. Signatures are essential for ensuring accountability for activities in a GMP environment at the time points the signatures are executed.
4.64. 在GMP環(huán)境中，簽名對于在簽名執(zhí)行時(shí)確保活動(dòng)可追溯、明確責(zé)任至關(guān)重要。

4.65. A signature represents the legally - binding will of the signatory. The signatory should sign with date and time. If signatures by initials are in use a procedure defining abbreviated signatures should be in place.
4.65. 簽名代表簽署人的具有法律約束力的意愿。簽署人應(yīng)注明簽署日期和時(shí)間進(jìn)行簽名。若使用首字母縮寫簽名，應(yīng)制定一份界定縮寫簽名規(guī)則的程序文件。

4.66 The identification of the signatory should be possible. Data or documents which are associated with the signature should be clearly identified. The meaning of the signa- ture (such as review, approve, responsibility, or authority) associated with the sig- nature should be clear.4.66 應(yīng)能夠識(shí)別簽名人身份。與簽名相關(guān)聯(lián)的數(shù)據(jù)或文件應(yīng)清晰識(shí)別。與簽名相關(guān)聯(lián)的簽名含義（如審核、批準(zhǔn)、負(fù)責(zé)、授權(quán)）應(yīng)清晰明確。
4.67 The regulated user should establish a signature policy to ensure the adequate applica- tion of signatures. Personal authorised to sign should be clearly identified by name and bound by a name or the signature policy.4.67 受監(jiān)管用戶應(yīng)制定簽名政策，以確保簽名的恰當(dāng)應(yīng)用。獲授權(quán)簽名的人員應(yīng)通過姓名清晰識(shí)別，并受姓名或簽名政策約束。
4.68 The regulated user should have identified those records which require a legally bind- ing signature.4.68 受監(jiān)管用戶應(yīng)識(shí)別出那些需要具有法律約束力簽名的記錄。
4.69 Signatures should be indelible and traceable on the paper and the signed docu- ment of record, if a signature is transcribed to a signature electronically.4.69 若簽名被轉(zhuǎn)錄為電子簽名，在紙質(zhì)文件以及已簽署的記錄文件上，簽名應(yīng)不可磨滅且可追溯。
4.70 If records exist only electronically, such records should be signed electronically. The use of electronic signatures should comply with the requirements of relevant laws and regulations (e.g. with hybrid system the electronic relevant signature should be distinctly categorised).4.70 若記錄僅以電子形式存在，此類記錄應(yīng)進(jìn)行電子簽名。電子簽名的使用應(yīng)符合相關(guān)法律法規(guī)要求（如在混合系統(tǒng)中，相關(guān)電子簽名應(yīng)明確分類）。
4.71 The signatory should be qualified and authorised to perform the relevant tasks or re- views.4.71 簽名人應(yīng)具備資質(zhì)并獲授權(quán)，以執(zhí)行相關(guān)任務(wù)或?qū)徍恕?br /> 4.72 The regulated user should define the signatory’s role and responsibility in the signa- ture process.4.72 受監(jiān)管用戶應(yīng)界定簽名人在簽名流程中的角色和職責(zé)。
4.73 The regulated user should ensure that the signatory’s role and qualification is con- sistent with the intent (content) of a signature.4.73 受監(jiān)管用戶應(yīng)確保簽名人的角色和資質(zhì)與簽名的意圖（內(nèi)容）相符。
4.74 To ensure the integrity of signatures during the whole life cycle of data the regulated user should establish the management and control of signatures as an element of data governance system.4.74 為確保數(shù)據(jù)整個(gè)生命周期中簽名的完整性，受監(jiān)管用戶應(yīng)將簽名的管理和控制作為數(shù)據(jù)治理體系的一個(gè)要素來建立。
4.75 The data or documents which the signature is relevant for should fulfill the ALCOA++ principles.4.75 簽名所關(guān)聯(lián)的數(shù)據(jù)或文件應(yīng)符合ALCOA++ 原則 。
 

RETENTION OF DOCUMENTS文件留存
4.76  It should be clearly defined which record is related to each activity and where this record is located, regardless of the technology, hybrid solution or service used. Risk - based control methods should be in place to ensure the integrity of the record through - out the lifecycle. The control measures should be covered by the validation scope. In case of electronic recording such measures should include back - up, restore and ar - chiving procedures as well as physical and logical controls. If the regulated user relies on hosted services, it is the responsibility of the regulated user to understand, approve and justify the control measures of a hosted service provider based on a service level agreement. Records should be available for review at any time applicable per the required retention period, accessible in a human readable format at any time applicable per the required.4.76 無論使用何種技術(shù)、混合解決方案或服務(wù)，都應(yīng)明確界定每項(xiàng)活動(dòng)對應(yīng)的記錄是什么，以及該記錄的存放位置。應(yīng)實(shí)施基于風(fēng)險(xiǎn)的控制方法，以確保記錄在整個(gè)生命周期內(nèi)的完整性。這些控制措施應(yīng)納入驗(yàn)證范圍。對于電子記錄，此類措施應(yīng)包括備份、恢復(fù)和歸檔程序，以及物理和邏輯控制。如果受監(jiān)管用戶依賴托管服務(wù)，受監(jiān)管用戶有責(zé)任了解、批準(zhǔn)并基于服務(wù)級(jí)別協(xié)議，對托管服務(wù)提供商的控制措施進(jìn)行合理性論證。在規(guī)定的留存期內(nèi)，記錄應(yīng)隨時(shí)可供查閱，且應(yīng)以人類可讀的形式提供給所有相關(guān)人員。
4.77 Specific requirements apply to batch documentation which must be kept for one year after expiry of the batch to which it relates or at least five - years after certification of the batch by the Qualified Person, whichever is the longer. For investigational medicinal products, the batch documentation must be kept for at least five years after completion of formal discontinuation of the last clinical trial in which the batch was used. In relation to specifications for radiopharmaceuticals (e.g. Advanced Therapy Medicinal Products and products derived from human blood or human plasma) and specify that longer retention periods be applied to certain documents.4.77特定要求適用于批次文件，這些文件必須在其相關(guān)批次過期后保存一年，或者在合格人員對該批次進(jìn)行認(rèn)證后至少保存五年，以時(shí)間較長者為準(zhǔn)。對于試驗(yàn)用藥品，批次文件必須在使用該批次的最后一次臨床試驗(yàn)完成或正式終止后至少保存五年。關(guān)于文件留存的其他要求，可能在與特定產(chǎn)品類型（如先進(jìn)治療醫(yī)藥產(chǎn)品以及源自人血或人血漿的產(chǎn)品）相關(guān)的法規(guī)中有所規(guī)定，并明確某些文件需適用更長的留存期限。
4.78. For other types of documentation, the retention period will depend on the business activity for which the documentation supports. Critical documentation, including raw data (for example relating to validation or stability), which supports information in the Marketing Authorisation should be retained whilst the authorization remains in force. It may be considered acceptable to retire certain documentation (e.g. raw data supporting validation reports or stability reports) where the data has been superseded by a full set of new data. Justification for this should be documented and should consider the requirements for retention of batch documentation; for example, in the case of process validation data, the accompanying raw data should be retained for a period at least as long as the records for all batches whose release has been supported on the basis of that validation exercise.4.78.對于其他類型的文件，留存期限將取決于文件所支持的業(yè)務(wù)活動(dòng)。關(guān)鍵文件，包括原始數(shù)據(jù)（例如與驗(yàn)證或穩(wěn)定性相關(guān)的數(shù)據(jù)），這些支持上市許可中信息的文件，應(yīng)在許可有效期內(nèi)留存。在數(shù)據(jù)已被一整套新數(shù)據(jù)取代的情況下，廢棄某些文件（如支持驗(yàn)證報(bào)告或穩(wěn)定性報(bào)告的原始數(shù)據(jù)）可能被視為可接受的做法。對此情況的合理性說明應(yīng)形成文件記錄，并且應(yīng)考慮批次文件留存的要求；例如，對于工藝驗(yàn)證數(shù)據(jù)，相關(guān)的原始數(shù)據(jù)留存期限應(yīng)至少與基于該驗(yàn)證活動(dòng)獲批放行的所有批次的記錄留存期限一樣長。
4.79. A documented process for the disposal of records should be in place to ensure that the correct original records or true copies are disposed of only after the defined retention period. Measures should be in place to reduce the risk of deleting the wrong documents. The access rights allowing disposal of records should be controlled.4.79. 應(yīng)建立文件化的記錄處置流程，以確保僅在規(guī)定的留存期限結(jié)束后，才對正確的原始記錄或真實(shí)副本進(jìn)行處置。應(yīng)采取措施降低刪除錯(cuò)誤文件的風(fēng)險(xiǎn)。允許處置記錄的訪問權(quán)限應(yīng)受到管控 。
 

DATA INTEGRITY IN DOCUMENTATION文件記錄的數(shù)據(jù)完整性
4.80. The method of documentation should be integrated in the regulated user’s pharmaceu- tical quality system. Documents or records should be controlled in a risk - based ap- proach regardless of whether located in - house or in the form of hosted services. The regulated user should apply the principles of data integrity, data criticality and data risk within a data governance system and should consider the complete lifecycle of data. The data governance system should be an element of the pharmaceutical quality system. The ownership of data and the responsibility for data integrity should be de- fined.4.80. 文件記錄方法應(yīng)融入受監(jiān)管用戶的藥品質(zhì)量體系。無論文件或記錄是內(nèi)部留存還是以托管服務(wù)形式存在，都應(yīng)采用基于風(fēng)險(xiǎn)的方法進(jìn)行管控。受監(jiān)管用戶應(yīng)在數(shù)據(jù)治理體系內(nèi)應(yīng)用數(shù)據(jù)完整性、數(shù)據(jù)關(guān)鍵性和數(shù)據(jù)風(fēng)險(xiǎn)原則，且應(yīng)考慮數(shù)據(jù)的完整生命周期。數(shù)據(jù)治理體系應(yīng)成為藥品質(zhì)量體系的一個(gè)要素。應(yīng)明確數(shù)據(jù)的所有權(quán)以及數(shù)據(jù)完整性的責(zé)任 。
4.81. Risk - based control measures should be commensurate with the type and the complex- ity of a system. The pharmaceutical quality system should interface with independent review practices to detect risks to data integrity. Risks from human factors should be considered for effectively ensuring data integrity. Risk - reducing measures such as sec- ond person oversight, verification and checks should be implemented where appropri- ate and in the appropriate time to ensure critical process and testing steps are accu- rately and contemporaneously recorded.4.81. 基于風(fēng)險(xiǎn)的控制措施應(yīng)與系統(tǒng)的類型和復(fù)雜程度相匹配。藥品質(zhì)量體系應(yīng)與獨(dú)立審核實(shí)踐相銜接，以發(fā)現(xiàn)數(shù)據(jù)完整性方面的風(fēng)險(xiǎn)。為有效確保數(shù)據(jù)完整性，應(yīng)考慮人為因素帶來的風(fēng)險(xiǎn)。在適當(dāng)情況下和適當(dāng)時(shí)間，應(yīng)實(shí)施諸如雙人監(jiān)督、核查與檢查等降低風(fēng)險(xiǎn)的措施，以確保關(guān)鍵工藝和測試步驟被準(zhǔn)確且同步地記錄 。
 

HYBRID SYSTEMS混合系統(tǒng)
4.82. They should be clearly defined and identified, and each contributing element of the system validated and controlled according to risk management principles.4.82. 應(yīng)對混合系統(tǒng)進(jìn)行清晰界定和識(shí)別，且系統(tǒng)的每個(gè)構(gòu)成要素都應(yīng)根據(jù)風(fēng)險(xiǎn)管理原則進(jìn)行驗(yàn)證和控制 。
4.83. A detailed description of the entire system should be available. The description should outline all major components, their functions, and interactions with each other as well as control for data management and data integrity. Procedures and records should be available to manage and appropriately control the interface between manual and com- puterised systems.4.83. 應(yīng)備有對整個(gè)系統(tǒng)的詳細(xì)描述。該描述應(yīng)概述所有主要組件、其功能、組件之間的相互作用，以及數(shù)據(jù)管理和數(shù)據(jù)完整性的控制情況。應(yīng)備有程序和記錄，以管理并妥善控制手動(dòng)系統(tǒng)與計(jì)算機(jī)化系統(tǒng)之間的接口 。
4.84. Appropriate quality risk management principles should be followed when assessing, defining, and demonstrating the effectiveness of control measures applied to the sys- tem.4.84. 在評估、界定和證明應(yīng)用于該系統(tǒng)的控制措施的有效性時(shí)，應(yīng)遵循適當(dāng)?shù)馁|(zhì)量風(fēng)險(xiǎn)管理原則 。
4.85 Procedures should be in place to manage the review of data generated by hybrid systems which clearly outline the process for the evaluation, approval and archiving of electronic and paper-based data.4.85 應(yīng)制定程序來管理對混合系統(tǒng)生成的數(shù)據(jù)的審查，這些程序應(yīng)明確概述電子數(shù)據(jù)和紙質(zhì)數(shù)據(jù)的評估、批準(zhǔn)及存檔流程。
 

GLOSSARY術(shù)語
ALCOA++
An acronym for “attributable, legible, contemporaneous, original and accu- rate”, which puts additional emphasis on the attributes complete, consistent, enduring, available and traceable – implicit basic ALCOA principles.ALCOA++是“可追溯（Attributable）、清晰可讀（Legible）、同步性（Contemporaneous）、原始性（Original）、準(zhǔn)確性（Accurate）” 的首字母縮寫，額外強(qiáng)調(diào)了完整性（Complete）、一致性（Consistent）、持久性（Enduring）、可用性（Available）、可追溯性（Traceable）這些屬性，而這些是基本ALCOA 原則中隱含的內(nèi)容。
Archiving歸檔
Long term, or permanent retention of completed documentation and relevant metadata in its final form for the purposes of reconstruction of a process or activity.
對已完成的文件以及相關(guān)（內(nèi)容，原文此處可能未完整顯示，按現(xiàn)有翻譯）進(jìn)行長期或永久性留存
Automated scriptA 自動(dòng)化腳本
piece of code used to automate repetitive processes一段用于自動(dòng)執(zhí)行重復(fù)流程的代碼
Data數(shù)據(jù)
The contents of the record. Data may be defined as measurable or descriptive attribute of a physical entity, process, or event.記錄的內(nèi)容。數(shù)據(jù)可被定義為物理實(shí)體、流程或事件的可測量或描述性屬性。
Data governance數(shù)據(jù)治理
The total sum of arrangements to ensure that data, irrespective of the format in which it is generated, recorded, processed, retained and used, will be attribut- able, legible, contemporaneous, original, accurate, complete, consistent, en- during, and available throughout the data lifecycle.為確保數(shù)據(jù)（無論其生成、記錄、處理、留存和使用的格式如何）在整個(gè)數(shù)據(jù)生命周期內(nèi)都具備可追溯性、清晰可讀性、同步性、原始性、準(zhǔn)確性、完整性、一致性、持久性和可用性，所采取的一系列安排的總和。
Data integrity數(shù)據(jù)完整性
Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, con- temporaneously recorded, original or a true copy, accurate and traceable (AL- COA++).數(shù)據(jù)完整性指數(shù)據(jù)的完整性、一致性和準(zhǔn)確性。完整、一致且準(zhǔn)確的數(shù)據(jù)應(yīng)具備可追溯性、清晰可讀性、同步記錄性、原始性或?yàn)檎鎸?shí)副本、準(zhǔn)確性和可追溯性（即ALCOA++ 原則 ） 。
Data lifecycle數(shù)據(jù)生命周期
All processes related to the creating, recording, processing, reviewing, changing, deleting, reporting, transferring, storing, migrating, archiving, retrieving, and analyzing of data.與數(shù)據(jù)的創(chuàng)建、記錄、處理、審核、變更、分析、報(bào)告、傳輸、存儲(chǔ)、遷移、歸檔、檢索和刪除相關(guān)的所有流程。
Data management數(shù)據(jù)管理
The set of all methodological, conceptual, organisational and technical measures and procedures for handling data with the aim of incorporating it into business processes.為將數(shù)據(jù)納入業(yè)務(wù)流程，處理數(shù)據(jù)時(shí)所采用的所有方法學(xué)、概念性、組織性以及技術(shù)性措施和程序的集合。
Data risk數(shù)據(jù)風(fēng)險(xiǎn)
The combination of the probability of occurrence of harm and the severity of that harm related to data (incompleteness, alterations or loss which compro - mise the integrity of data).與數(shù)據(jù)相關(guān)的危害發(fā)生概率和危害嚴(yán)重程度的組合（數(shù)據(jù)不完整、被篡改或丟失，從而損害數(shù)據(jù)完整性）。
Data criticality數(shù)據(jù)關(guān)鍵性
The degree of influence that data have on product safety as well as the regulatory compliance of processes, decisions and product quality.數(shù)據(jù)對產(chǎn)品安全性以及法規(guī)合規(guī)流程、決策和產(chǎn)品質(zhì)量的影響程度。
Data Risk Management數(shù)據(jù)風(fēng)險(xiǎn)管理
An activity to be applied throughout the lifecycle of data considering the need to ensure data integrity. Risk management consists of risk identification, risk assessment, risk mitigation (e.g. risk acceptance, risk control, Risk management should link to relevant processes for data, configuration, and change management, man - agement procedures (e.g. business rules, etc.).一項(xiàng)需在數(shù)據(jù)的整個(gè)生命周期中開展的活動(dòng)，需考慮確保數(shù)據(jù)完整性的需求。風(fēng)險(xiǎn)管理包括風(fēng)險(xiǎn)識(shí)別、風(fēng)險(xiǎn)評估、風(fēng)險(xiǎn)緩解和風(fēng)險(xiǎn)控制。風(fēng)險(xiǎn)管理應(yīng)考慮其他相關(guān)程序（如配置與變更管理、數(shù)據(jù)管理流程、業(yè)務(wù)風(fēng)險(xiǎn)等）。
Data Risk Assessment 數(shù)據(jù)風(fēng)險(xiǎn)評估 
The process of evaluating the risks associated with the regulated user's data. It ensures an efficient and effective approach to data integrity by considering the vulnerability of data to involuntary or deliberate alteration resulting in risk - based control measures.評估與受監(jiān)管用戶數(shù)據(jù)相關(guān)風(fēng)險(xiǎn)的過程。通過考量數(shù)據(jù)因無意或蓄意篡改而面臨的脆弱性，以確保采用高效且有效的方法保障數(shù)據(jù)完整性，進(jìn)而制定基于風(fēng)險(xiǎn)的控制措施。
Data ownership數(shù)據(jù)所有權(quán)
The allocation of responsibilities for control of data to a specific process owner. Companies should implement systems to ensure that responsibilities for systems and their data are appropriately allocated and responsibilities understood.將數(shù)據(jù)控制的職責(zé)分配給特定的流程所有者。公司應(yīng)實(shí)施相關(guān)系統(tǒng)，以確保系統(tǒng)及其數(shù)據(jù)的職責(zé)得到恰當(dāng)分配，且職責(zé)被清晰理解。
Data quality數(shù)據(jù)質(zhì)量
The degree to which a set of inherent characteristics (quality dimensions) of data fulfill requirements.Data should be fit for use in their intended operational, decision - making, and other roles and should exhibit conformance to regulatory standards that have been set, so that fitness for use is achieved.數(shù)據(jù)的一組固有特性（質(zhì)量維度）滿足要求的程度。數(shù)據(jù)應(yīng)適用于其預(yù)定的操作、決策制定及其他用途，并且應(yīng)符合已設(shè)定的監(jiān)管標(biāo)準(zhǔn)，從而實(shí)現(xiàn)適用性。
Document文件
A formatted compilation of data. Operations and activities that are memorialized in (electronic) records may consist of one or more documents that describe the activity in a moment of time.經(jīng)過格式化的數(shù)據(jù)匯編。在（電子）記錄中記錄的操作和活動(dòng)，可能由一個(gè)或多個(gè)描述某一時(shí)刻活動(dòng)的文件組成。
Electronic record電子記錄
Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.以數(shù)字形式呈現(xiàn)的文本、圖形、數(shù)據(jù)、音頻、圖片或其他信息表示的任意組合，由計(jì)算機(jī)系統(tǒng)創(chuàng)建、修改、維護(hù)、歸檔、檢索或分發(fā)。
Hybrid system混合系統(tǒng)
A combination of paper - based and electronic means.基于紙質(zhì)和電子方式的組合。
Homogenous systems同類系統(tǒng)
A system that is either paper or electronically based on - premises or a cloud service.一種要么基于紙質(zhì)，要么基于本地電子方式，要么基于云服務(wù)的系統(tǒng)。
Meta data元數(shù)據(jù)
Describe the attributes of data and provides context and meaning. Metadata is any information used for the identification, description, and relationships of electronic records or their elements. Metadata gives data meaning, provides context, defines structure, and enables retrievability across systems, and usability, authenticity, and auditability across time.描述數(shù)據(jù)的屬性并提供背景和含義。元數(shù)據(jù)是用于識(shí)別、描述電子記錄或其元素及其相互關(guān)系的任何信息。元數(shù)據(jù)賦予數(shù)據(jù)意義、提供背景、定義結(jié)構(gòu)，使數(shù)據(jù)能在系統(tǒng)間檢索，并確保其在不同時(shí)間的可用性、真實(shí)性和可審計(jì)性。
Raw Data原始數(shù)據(jù)
Raw data is defined as the original record (data) which can be described as the first capture of stored information, whether recorded on paper or electronically.Information that is originally captured in a dynamic state should remain available in that state.原始數(shù)據(jù)被定義為原始記錄（數(shù)據(jù)），可描述為對存儲(chǔ)信息的首次捕獲，無論其是記錄在紙質(zhì)上還是以電子方式記錄。最初以動(dòng)態(tài)狀態(tài)捕獲的信息應(yīng)在該狀態(tài)下保持可用。
Record記錄
Memorializes, or makes information permanent about, an action, activity and event that caused its creation.記錄使關(guān)于引發(fā)其創(chuàng)建的行動(dòng)、活動(dòng)和事件的信息得以留存或永久保存。
Regulated user受監(jiān)管用戶
Marketing Authorisation Holder, Manufacturers, control laboratories, import - ers, and wholesale distributors (if the wholesale distributor holds a manufacturing license).上市許可持有人、制造商、控制實(shí)驗(yàn)室、進(jìn)口商和批發(fā)分銷商（若批發(fā)分銷商持有生產(chǎn)許可證）。
Risk based approach for data integrity基于風(fēng)險(xiǎn)的數(shù)據(jù)完整性方法
A process to define critical data, documents and the actions used to monitor activities like capturing, derivation, migration, storage, communication and archiving to ensure that data and documents remain in a state of control throughout the entire lifecycle and to maintain its integrity.一種用于界定關(guān)鍵數(shù)據(jù)、文件以及用于監(jiān)控諸如捕獲、推導(dǎo)、遷移、存儲(chǔ)、傳輸和歸檔等活動(dòng)的行動(dòng)的流程，以確保數(shù)據(jù)和文件在整個(gè)生命周期內(nèi)都處于受控狀態(tài)，并維持其完整性。
Specification質(zhì)量標(biāo)準(zhǔn)
A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. “Conformance to specification” means that the material, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.一份包含測試項(xiàng)目、分析方法引用以及適用接受標(biāo)準(zhǔn)（為所述測試設(shè)定的數(shù)值限度、范圍或其他標(biāo)準(zhǔn)）的清單。它確立了物料為實(shí)現(xiàn)預(yù)期用途應(yīng)符合的一系列標(biāo)準(zhǔn)。“符合質(zhì)量標(biāo)準(zhǔn)” 指當(dāng)按照所列分析方法對物料進(jìn)行測試時(shí)，物料會(huì)滿足所列接受標(biāo)準(zhǔn) 。
True copy真實(shí)副本
An exact copy of original documentation that preserves the same content, meaning and attributes of the original. The term “true copy” is synonymous with “certified” or “verified copy”.原始文件的精確副本，保留與原始文件相同的內(nèi)容、含義和屬性。“真實(shí)副本” 一詞與“經(jīng)認(rèn)證副本” 或“經(jīng)核實(shí)副本” 同義 。
Type of service服務(wù)類型
On - premises IT service or outsourced hosted (cloud) IT service本地信息技術(shù)服務(wù)或外包托管（云）信息技術(shù)服務(wù)
Verified copy經(jīng)核實(shí)副本
Refers to definition of true copy指“真實(shí)副本” 的定義（即與“真實(shí)副本” 定義一致 ，說明其遵循真實(shí)副本的界定 ）
Data Risk Assessment數(shù)據(jù)風(fēng)險(xiǎn)評估
The process of evaluating the risks associated with the regulated user’s data.評估與受監(jiān)管用戶數(shù)據(jù)相關(guān)風(fēng)險(xiǎn)的過程。