USP<1029>文件管理规范草案-----Julia

巴西木

BRIEFING

<1029> Good Documentation Guidelines. This proposed new general chapter provides guidelines on how to develop and maintain good documentation practices within Good Manufacturing Practice (GMP) operations. This chapter was created to address a need for descriptions of what constitutes good documentation, for example, records of all types that are clear, accurate, and complete. These records may include protocols, procedures, reports, and raw data. The overarching goal of this chapter is to provide useful information to the GMP-regulated industries, thereby assisting the user in designing procedures that will promote record integrity and control. In turn, record integrity and control are essential for the evaluation and reconstruction of GMP activities, and ultimately for ensuring the quality and safety of regulated ingredients and products.

<1029>优良文件记录指南。该新起草章节指导如何在GMP操作下建立和维护优良文件规范。创建本章是为了说明建立优良文件记录的必要性，例如，所有类型记录均应清楚、准确和完整。这些记录可能包括方案、程序、报告和原始数据。本章首要目标是给GMP相关行业提供有用的信息，从而帮助使用者设计程序来提升记录完整受控性。记录完整受控对于GMP活动的评估和重现是非常重要的，最终可以保证受法规制约的成分和产品的质量和安全性。

(GCPA: A. Hernandez-Cardoso.)

Correspondence Number—C140448

Comment deadline: July 31, 2014

Add the following:

1029 GOOD DOCUMENTATION GUIDELINES

优良文件记录指南

INTRODUCTION 介绍

Purpose 目的

Documentation can be viewed as the foundation of all quality systems because clear, complete, accurate records are essential to all operations and procedures. This general chapter provides guidelines on good documentation practices for the Good Manufacturing Practice (GMP)-regulated industries, to be used in the production and control of pharmaceutical products, active pharmaceutical ingredients (APIs), excipients, dietary supplements, food ingredients, and medical devices. This chapter describes the underlying principles of proper documentation for GMP operations to assist the user in the evaluation and reconstruction of GMP activities. These guidelines should be helpful for building the basic foundation of a quality system that will ensure proper documentation as well as record integrity and control.

文件记录可以被看作是所有质量体系的基础，因为清楚、完整、准确的记录对所有操作和程序来说都是基本的要求。本章对于GMP法规相关行业的优良文件记录规范提供指南，可用于制剂、原料药、辅料、膳食补充剂、食品成分和医疗器械企业。本章描述了GMP操作文件记录的原则，帮助使用者评估和重现其GMP活动。这些指南将有助于建立质量体系基础，保证适当的文件记录以及记录完整并受控。

Scope 范围

This chapter covers different levels and types of documentation, including paper and electronic records that consist of raw data, reports, protocols, and procedures related to manufacturing controls and analytical data. The chapter also includes recommendations on information that should be recorded for various types of GMP documents.

本章包括了不同层次和文件记录类型，包括纸质和电子记录，包括与生产控制和分析数据有关的原始数据、报告、方案和程序。本章也包括对不同类型GMP文件所要记录信息的建议。

This chapter does not provide information about all applicable legal requirements, nor does it affect any applicable requirements under GMP regulations, state laws governing pharmacy, or provisions under approvals.

本章无意提供关于所有适用法规要求的信息，也无意对所有GMP法规、国家药品法或批准的条款下适用要求产生影响。

PRINCIPLES OF GOOD DOCUMENTATION 优良记录的原则

All steps related to the manufacturing, testing, packaging, or holding of a raw material, component, API, finished product, or other similar item should be documented.

所有与原料、部件、原料药、制剂或其它类似物品的生产、检测、包装或保存相关的步骤均应进行记录。

Good documentation principles for manual or electronic records include the following, as applicable:

手工或电子优良记录原则包括以下（适用时）

·    Records should be clear, concise, accurate, and legible.

·    记录应清楚、简洁、准确及清晰可辩

·    Data entries should be recorded promptly when actions are performed.

·    在实施操作时应及时记录数据

·    Backdating and postdating are prohibited.

·    禁止倒签日期和提前日期

·    All corrections to the original entries should be initialed and dated, with an explanation included in cases where the reason for the change is not obvious.

·    所有对原始输入的修正均应有人签字和注明日期，如果修正的理由不明显还需要记录对修正的解释

·    Data entries should be traceable to the person who made the entry.

·    数据输入操作应可追溯到输入人

·    Use of shorthand notations is not allowed.

·    不允许使用速记符号

·    Controls should be in place to protect the integrity of the records.

·    应有适当的控制程序，以保护记录的完整性

·    In the event that ink may have faded over time (e.g., thermal paper), a copy can be used with verification of its accuracy; the analyst should initial and date the copy.

·    如果打印墨水容易褪色（例如热敏纸），可以对打印内容进行复印以确认其准确性，化验员应在复印件上签字及注明日期

·    An adequate documentation system is needed to ensure the traceability and availability of current and archived records.

·    要制订完善的文件记录系统，以保证在用和存档记录的可追溯性和可获得性

·    Notebooks, data sheets, and worksheets should be prenumbered with a tracking system to ensure the traceability and integrity of data.

·    笔记本、数据表和工作表单均应根据一个追踪系统进行预先编号，以保证数据的可追溯性和完整性

·    Records should be retained per regulatory requirements.

·    记录应按法规要求保存

·    Attachments (supporting documents) should be paginated with a reference to the parent document.

·    附件（支持性文件）应编制页码，并可索引至主文件

DATA COLLECTION AND RECORDING 数据收集和记录

Formats for data collection and recording include, but are not limited to, the following:

数据收集和记录格式包括但不仅限于以下：

·    Paper forms, data sheets, and worksheets

·    纸质形式、数据表、工作表单

·    Notebooks and logbooks

·    记录本和日志

·    Instrument printouts

·    仪器打印数据

·    Electronic data obtained with a system such as an electronic data system, laboratory information management system (LIMS), or electronic laboratory notebook (ELN).

·    系统产生的电子数据，例如电子数据系统、实验室信息管理系统（LIMS）或化验室电子记录本（ELN）

All data should be recorded directly and legibly in indelible ink when the activity is performed. Sticky notes and other transitory loose papers must not be used for documentation of GMP activities. All data entries should be traceable to who made the entry and when. Additionally, electronic records must meet the requirements of the Code of Federal Regulations Title 21 (21 CFR), Part 11.

所有数据均应在活动进行时，采用永久墨水清晰地直接记录。GMP活动的记录中不可使用便贴纸和其它临时使用的松散页。所有数据输入均应可以追溯到输入数据的个人。另外，电子记录必须符合21CFR11部分的要求。

Any change to an entry should be made in a way that does not obscure the original entry, with an explanation in cases where the reason for the change is not obvious. Changes should be traceable to who made the change and when. Predefined correction codes may be used, for example, WD = wrong date.

对已输入数据的任何改动均应保持原输入的可读性，如果改动的原因不明显，还要注明对改动的解释。改动应可追溯到是谁、什么时间做的改动。可以使用预先制订的修正代码，例如WD=日期错误。

Notebook pages and worksheets should be used consecutively, and information should be recorded chronologically. GMP records such as batch records, test methods, and specifications should be given unique identifiers using version control.

记录本的页和工作表单应连续使用，信息应按时间顺序记录。GMP记录如批记录、检测方法和质量标准应给予唯一的识别编号并采用版本号进行控制。

All data entry fields should be completed. A single line and/or “N/A” should be drawn through portion(s) of a page that are not used. If the record is in an electronic system and the system provides traceability of who filled each field and when, the field can be left blank.

所有的数据输入域均应填写完整。一页中未使用的部分应划一条单线和/或填写“N/A”。如果记录是电子系统，系统支持对填写人、填写时间和填写域的追溯，则该域可以留为空白。

Decimals less than one should be preceded by a zero. Rounding rules and guidelines on significant figures are described in USP–NF General Notices and Requirements.

小于1的小数前面应加0。有效数字修约规则和指南在USP-NF通则中。

All dates should be expressed in a format that clearly indicates the day, month, and year.

所有日期格式均应清楚指明年月日。

All documentation should undergo appropriate review and signature by a second person to confirm the accuracy, compliance, and completeness of the entries. Additional signatures may be required on the basis of local Standard Operating Procedures (SOPs) for different levels of review (e.g., performed by, verified by, checked by, reviewed by, approved by) as accountability steps.

所有记录均应由第二人进行适当的审核，并签字以确认其准确性、合规性和输入的完整性。内部SOP可以规定责任分工，并需要不同层级的审核（例如，由谁实施、由谁核对、由谁检查、由谁审核、由谁批准）。

An official record of signature and initials should exist for each employee. Controls should be in place for assigning signature approval requirements and delegation of signature authority, when needed.

要有一份正式的记录记载每个员工的签名和首字母。必要时，应有程序控制批准签字授权。

Instrument printouts and data sheets should be initialed and dated, and should contain a unique, traceable reference or be affixed to a reference document.

仪器打印纸和数据表应有签字并注明日期，其中应包括一个唯一的可追溯的索引号，或装订在主文件中。

In the event that verified copies of raw data have been prepared, the verified copy may be substituted for the original source as raw data, if clearly marked as such.

如果准备了经过核对的原始数据的副本，并清楚标明，则该副本可以用于代替原始文件作为原始数据。

All GMP documents with multiple-page printouts should be signed on the first page with a note indicating the total number of pages. The first page and all subsequent pages should have a unique, traceable reference to the activity being performed, such as the notebook reference, study number, or worksheet reference.

所有多页GMP文件打印均应在首页签字，并注明总页数。首页和所有后续页均应可以唯一地追溯至所实施的活动，例如记录本索引、研究编号或工作表单索引。

DIFFERENT TYPES OF GMP DOCUMENTS  不同GMP文件类型

The following or similar documents created in the laboratory should include the following information, but are not limited to these items.

在化验室创建的以下或类似文件应包括，但不仅限于以下项目：

Laboratory Records 化验室记录

Each record should be concise, clear, legible, and accurate, and detail the following:

每份记录应简洁、清楚、清晰和准确，包括以下详细信息：

·    Description of materials, such as reagents. This information typically includes the material name, manufacturer and lot number, titer or concentration, expiration date, quality (if known), and a reference to the lab notebook if prepared in the lab.

·    对物料的描述，如试剂。该信息一般包括物料名称、生产商和批号、滴定度或浓度、有效期、质量（如已知）和对化验室记录本的索引（如果是由化验室制备）

·    Identification of equipment used. This information typically includes equipment name, unique control number, and calibration expiration date.

·    所用设备的识别信息。该信息一般包括设备名称、唯一控制编号和校正有效期

·    Procedures used

·    所用操作程序

·    Measurements

·    测量过程

·    Formulae and calculations

·    公式和计算

·    Results and conclusions

·    结果和结论

Equipment-Related Documentation 设备相关文件记录

All equipment used in manufacturing, testing, packing, or holding of a raw material, component, API, finished product, or other similar item should be maintained and qualified for its intended use. The documentation related to equipment includes:

所有用于原料、部件、原料药、制剂或其它类似项目的生产、检测、包装的设备均应进行维护，确认其适于既定用途。设备相关文件包括：

·    Policies and procedures for operation and maintenance

·    操作和维护方针和程序

·    Maintenance logs

·    维护日志

·    Calibration or qualification records

·    校正或确认记录

·    Instrument labeling

·    仪器标签

Investigations and Deviations 调查和偏差

All aberrations, anomalies, exceptions, and issues related to manufacturing, testing, packing, or holding of a raw material, component, API, finished product, or other similar item should be documented. Once documented, the deviation should be evaluated and investigated, as appropriate. Planned and unplanned deviations should be justified. Procedures should be in place for documenting, evaluating, and investigating such events. Documentation of the investigation should include the following:

所有与原料、部件、原料药、制剂或其它类似物品的生产、检测、包装或保存有关的偏差、异常、例外和相关情况均应进行记录。一旦记录，偏差应进行评估，适当时应进行调查。计划内和计划外偏差应进行判定。应有程序规定如何记录、评价和调查这些事件。调查记录应包括以下内容：

·    Description of the event

·    事件描述

·    Root-cause investigation and trend analysis

·    根本原因调查和趋势分析

·    Responsibilities of people involved in the investigation or deviations

·    调查或偏差相关责任人

·    Corrective Action and Preventive Action (CAPA) with timelines

·    纠正措施和预防措施及时间表

·    Review and approval

·    审核和批准

Batch Records 批记录

A Master Batch Record (MBR) is created as a template for the manufacture of a specific product. An Executed Batch Record, based on the MBR, is used to document the steps and materials involved in the production of a specific batch of a raw material, component, API, finished product, or other similar item. Typically, the following sections are included in a Batch Record, and should be approved by an appropriate representative from the manufacturing site or packaging site:

每个产品均应制订一份批生产记录母版（MBR），实际生产批次记录，基于该MBR，用于记录原料、部件、原料药、制剂或其它类似物品的生产相关步骤和所用原料。批记录一般应包括以下部分，且由生产场所或包装场所内相应的代表批准：

·    Header information (e.g., product name, batch number, manufacturing site)

·    抬头信息（例如，产品名称、批号、生产场所）

·    Unit of operation (e.g., blending, coating, filling)

·    操作单元（例如、混合、包衣、充填）

·    Manufacturing process

·    生产工艺

o      Target weights (raw materials)

o      目标重量（原料）

o      Conditions (time, temperature)

o      条件（时间、温度）

o      Deviations and investigations

o      偏差和调查

·    In-process sampling or testing

·    中控取样和检测

·    Critical information, as applicable

·    关键信息，适用时

·    Sampling plan for release, stability, and retention

·    放行、稳定性和留样的取样计划

·    Review and approval with approval dates

·    审核和批准及日期

Certificate of Analysis 分析报告

The purpose of the Certificate of Analysis (C of A or CoA) is to report analytical results for a specific batch of a raw material, component, API, finished product, or other similar item. Typically, the following sections are included on a C of A and should be approved by an appropriate representative from the testing site:

分析报告（CoA）的目的是对原料、部件、原料药、制剂或其它类似物品特定批次的分析结果进行报告。分析报告书一般包括以下部分并由检测场所适当的代表批准：

·    Vendor or supplier information

·    贸易商或供应商信息

·    Product information (name and strength)

·    产品信息（名称和剂量）

·    Results for the specific batch, with name of test, acceptance criteria, and result for each test

·    特定批次的结果，包括检测项目名称、可接受标准和各项测试的结果

·    Conformance statement

·    符合情况声明

·    Reference to method and specification document

·    对检验方法和质量标准文件的索引

·    Reference of data source

·    数据来源的索引

·    Approval and date

·    批准和日期

·    Expiration date or retest information

·    效期或复验期

Standard Operating Procedures 标准操作程序

The purpose of an SOP is to provide directions to trained personnel regarding a given set of activities. SOPs should be clear and concise. The following sections are typically included in an SOP:

SOP的目的是给经过培训的人员提供某一活动的指导。SOP应清楚、简洁。SOP一般包括以下部分：

·    Purpose and scope

·    目的和范围

·    Instructions and procedure

·    操作指示和流程

·    Responsibilities and roles

·    职责和分工

·    Materials or equipment, as appropriate

·    原料或设备，适当时

·    Definitions or references, as needed

·    定义或索引，需要时

·    Review and approval

·    审核和批准  

·    Revision history

·    修订历史

Protocols and Reports 方案和报告

Many tasks and activities in the laboratory are executed on the basis of a predefined, preapproved protocol. The results of these activities are then documented in a final report with conclusions. Examples of such activities are as follows:

化验室的许多任务和活动是基于经过批准的预定方案来执行的，这些活动的结果会连同结论一起记录在一个最终的报告中。这些活动举例如下：

·    Equipment qualification

·    设备确认

·    Analytical method validation or verification

·    分析方法验证或确认

·    Manufacturing process validation

·    生产工艺验证

·    Analytical method or manufacturing technology transfer

·    分析方法或生产技术转移

·    Cleaning validation

·    清洁验证

·    Stability study or testing

·    稳定性试验或测试

·    Comparability study

·    对比性研究

Both the protocol and the report should typically include the following sections:

方案和报告一般均包括以下部分：

·    Purpose

·    目的

·    Plan or instructions

·    计算或指令

·    Predetermined acceptance criteria

·    预定的可接受标准

·    Deviations or investigations, including impact assessment

·    偏差或调查，包括影响性评估

·    Assessment or evaluation

·    评估或评价

·    Data reference

·    数据索引

·    Review and approval

·    审核和批准

·    Revision history

·    修订历史

Analytical Methods 分析方法

Analytical methods provide direction to an operator on how to perform a given analytical test. The following sections will typically be included in the analytical method:

分析方法提供给操作人员指引，告知如何实施指定的分析测试。分析方法一般包括以下部分：

·    Purpose 目的

o      Test information 检测信息

o      Product information 产品信息

·    Safety information 安全信息

·    Materials and equipment 物料和设备

·    Procedure, as applicable 程序，适用时

o      System suitability 系统适用性

o      Preparation of solutions and reagents 溶液和试剂制备

o      Preparation of standards and samples 标准品和样品制备

o      Instrument parameters 仪器参数

o      Calculations and reporting 计算和报告

·    Review and approval with approval dates 审核和批准及批准日期

·    Revision history 修订历史

Training Documentation 培训文件记录

Personnel should be trained to perform their assigned tasks. The training should be documented, and the training records should be retained and kept readily accessible. Training records should be reviewed on a periodic basis for accuracy and completeness. In general, training documentation should include:

人员均应接受其完成工作所必须的培训。培训应有记录，培训记录应保留并易于取得。培训记录定期进行审核，以保证其准确性和完整性。一般来说，培训记录应包括：

·    Training description including name of training, version, and mode (self-training or instructor led)

·    培训描述，包括培训名称、版本和培训方式（自修或培训师指导）

·    Completion date

·    完成日期

·    Information on the trainer’s qualifications

·    培训人员资质信息

Retention of Documents 文件保存

An adequate policy for record retention and archiving should be established for the above records. The required length of time depends on the regulatory requirements or company procedures; however, it should be at least 1 year after the batch expiration date

应设定方针，对上述记录进行充分地保存和存档。要求的保留时间取决于法规要求或公司程序，但至少应保留至该批次有效期后一年。

. 1S (USP38)

Auxiliary Information - Please check for your question in the FAQs before contacting USP.

三尺之冰

这个指南应该还在PF上公示吧？预计会加入哪一版的USP了？

syhorchid

谢谢分享

xhf123456

谢谢楼主分享。

三尺之冰

sunjun 发表于 2014-6-19 21:55
这个指南应该还在PF上公示吧？预计会加入哪一版的USP了？

呵呵！感觉USP38会有大动作啊！重金属方法由比色法变为原子吸收应该势在必行了吧？？？

seamen

1029不是  灭菌那一章节吗、？

egongwenwu

比较全面的文件管理文

yolanda8878

学习了GDP

terbiumcf

感谢分享,谢谢了。

scslk0045

好像USP40已经收录了

云卷云舒0415

谢谢分享

zhfttaifeizi

学习，分享！

littlehan601

有帮助，谢谢分享！

yang_jur

真真学些了，谢谢分享

pandorasc

我要慢慢学习，不能太快了，否则记不住

hhxx2018

感谢分享。

冷雪清风

找USP目录来研究下，原来还包括这个啊

小颖果儿

谢谢！辛苦！

小金库

非常感谢分享