混淆视EUROPEAN COMMISSION
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Public Health and Risk Asssment
Pharmaceuticals
Brusls,
SANCO/C8/AM/sl/ares(2010)1064587
EudraLex
The Rules Governing Medicinal Products in the European Union
Volume 4
Good Manufacturing Practice
Medicinal Products for Human and Veterinary U
Chapter 4: Documentation
第四章：文件
Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human u and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human u and Directive 91/412/EEC for veterinary u.
立法基础：2001/83/EC法令第47款对人用药品的相关要求，2001/82/EC法令第51款兽用药相关的欧共体法规。本文件主要是2003/94/EC法令对人用药和91/412/EEC对兽用药品的GMP原则和指南的解释。
Status of the document: revision 1
文件状态：第一次修订
Reasons for changes: the ctions on "generation and control of documentation" and "retention of documents" have been revid, in the light of the increasing u of electronic documents within the GMP environment.
变更理由:鉴于GMP环境下电子文档的增加，对“文件的生成和控制”和“文件和保存”进行修订
Deadline for coming into operation: referred30 June 2011
实施时间：2011年6月30日
Table of Contents目录
Principle有创意的班级口号原则
Required GMP Documentation要求的GMP文件
Generation and Control of Documentation文件生成和控制
Good Documentation Practices优良
Retention of Documents记录保存
Specifications质量标准
Manufacturing Formula and Processing Instructions生产处方和工艺规程
Procedures and records程序和记录
Principle原则
Good documentation constitutes an esntial part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents and media ud should be fully defined in the manufacturer's Quality Management System.好的文件管理，是质量保证系统的一个关键部分，对于GMP符合性操作至关重要。在生产商的质量管理体系中应对所使用的各种文件和媒质的类型进行全面界定。
Documentation may exist in a variety of forms, including paper-bad, electronic or photographic media. The main objective of the system of documentation utilized must be to establish, control, monitor and record all activities which directly or indirectly impact on all aspects of the quality of medicinal products. The Quality Management System should include sufficient instructional detail to facilitate a common understanding of the requirements, in addition to providing for sufficient recording of the various process and evaluation of any obrvations, so that ongoing application of the requirements may be demonstrated.文件可以各种形式存在，包括纸质、电子的或图像，公司应建立、控制、监督文件记录系统所采用的主要方法，并记录下所有会对药品质量各方面产生直接或间接影响的活动。质量管理系统应对记录方式有足够的细致操作说明，这样除了对各工艺有充分记录，对各缺陷有评价外，还方便对记录要求有一般性了解，才可以达到应用目的。
There are two primary types of documentation ud to manage and record GMP compliance: instructions (directions, requirements) and records/reports. Appropriate good documentation practice should be applied with respect to the type of document.这里有两种基本记录方式应用于GMP符合性管理和记录中：操作说明（指令、要求）和记录/报告，
怎么做土豆饼
公司应根据不同文件类型，采用相应的优良文件规范。
Suitable controls should be implemented to ensure the accuracy, integrity, availability and legibility of documents. Instruction documents should be free from errors and available in writing. The term ‘written’ means recorded, or documented on media from which data may be rendered in a human readable form.应对文件进行适当的控制以保证文件的准确、完整、有效及清晰易读。操作说明类文件应没有错误并有书面版本发行。术语“书面”意思是在某种介质上记录或记载，以使数据形式可以被人们读出。
Required GMP documentation (by type):所需要的GMP生活片电视剧文件（按类型）
Site Master File: A document describing the GMP related activities of the manufacturer.
工厂主文件：描述生产商与GMP豆皮的做法大全相关活动的文件。
Instructions (directions, or requirements) type:拆除工程施工方案规程（指令，或要求）类型
Specifications Describe in detail the requirements with which the products or materials u
d or obtained during manufacture have to conform. They rve as a basis for quality evaluation.
质量标准：是对产品或所用原料或中间产品所必须符合的要求的详细说明。这是质量评价的一个基础。
活动策划流程
Manufacturing Formulae, Processing, Packaging and Testing Instructions: 生产处方，生产、包装和检测说明，
Provide detail all the starting materials, equipment and computerid systems (if any) to be ud and specify all processing, packaging, sampling and testing instructions. Inprocess controls and process analytical technologies to be employed should be specified where relevant, together with acceptance criteria.
规定所有使用的起始物料、设备和计算机系统（如有）的详细要求，并说明所有工艺、包装、取样和检测规程，还需要说明相关的中控和所使用的过程分析技术及可接受标准。
Procedures: (Otherwi known as Standard Operating Procedures, or SOPs 也称为标准
操作规程，或SOPs), give directions for performing certain operations.
规程：是对某一项工作的说明。
Protocols: Give instructions for performing and recording certain discreet operations.
记录：是形成每一批产品的历史，包括发送给客户，也包括其他相关的可能会影响最终产品质量的因素。
