2011 PIC-S 工厂主文件指南

2011 PIC/S 工厂主文件指南 PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION COOPERATION SCHEME 药品检查协定和药品检查合作计划组织 PE 0084 1 Annex 1 January 2011 PE 0084 附件一 2011 年 1 月 1 日 EXPLANATORY NOTES FOR PHARMACEUTICAL PREPARATION OF A SITE MASTER FILE 制药工厂现场主文件编写说明 MANUFACTURERS ON THE ?PIC/S January 2011 Reproduction prohibited for commercial purposes Reproduction for internal use is authorized Provided that the source is acknowledged Editor/编著: email/邮箱: web site/网站: PIC/S Secretariat info@picscheme.org http://www.picscheme.org TABLE OF CONTENTS 目录

2011 PIC/S 工厂主文件指南 1 2 3 4 5 6 Document History/文件历史...................................................................................2 Introduction/简介....................................................................................................2 Purpose/目的.........................................................................................................2 Scope/范围............................................................................................................3 Content of Site Master File/现场主文件内容..........................................................3 Revision History/修订历史.....................................................................................3 1 DOCUMENT HISTORY 文件历史 2 INTRODUCTION 简介 Adoption by the PIC Committee of Officials of PH 4/93 PIC 会正式采用 PH4/93 Entry into force of PH 4/93 PH 4/93 生效 Entry into force of PE 0081 PE 0081 生效 22-23 April 1993 1993 年 4 月 22-23 April 1993 1993 年 3 月 1 November 2002 2002 年 11 月 1 日 2.1 The Site Master File is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carr out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carr out on the site, a Site Master File need only describe those operations, e.g. analysis, packaging, etc. 现场主文件是由制药厂家编写,并包含以下信息:质量管理方针及现场活动、在对在指定现场进行生 产或/和对在指定现场的制药生产操作进行的质量控制以及在临近及附近建筑内进行的一体化操作。

如果仅有一部份制药操作在该现场进行,那么 SMF 仅需描叙该类操作即可,如:分析、包装、等。

2.2 When submitted to a regulatory authority, the Site Master File should provide clear information on the manufacturer’s GMP related activities that can be useful in general supervision and in the efficient planning and undertaking of GMP inspections. 提交至监管机构时,SMF 需 明确信息,说明厂家进行的有助于一般监管和 GMP 审查有效计划和应对的相关 GMP 活动 2.3 A Site Master File should contain adequate information but, as far as possible, not exceed 25-30 pages plus appendices. Simple plans, outline drawings or schematic layouts are preferred instead of narratives. The Site Master File, including appendices, should be readable when printed on A4 paper sheets.

2011 PIC/S 工厂主文件指南 SMF 应包含足够的信息,但是加上附件不得超过 25-30 页。

相较于详述,简单性计划、简略的原理 图布局图为首选。

SMF,包括附件,用 A4 纸打印出来应当可读。

2.4 The Site Master File should be a part of documentation belonging to the quality management system of the manufacturer and kept updated accordingly. The Site Master File should have an edition number, the date it becomes effective and the date by which it has to be reviewed. It should be subject to regular review to ensure that it is up to date and representative of current activities. Each Appendix can have an individual effective date, allowing for independent updating. SMF 厂家质量管理系统文件的一部分,应进行相应更新。

SMF 应当有一个版本号、生效日期以及需 进行审核的日期。

应对 SMF 进行定期审核以保证其为最新版本并体现最新行动。

每个附件可有单独 的生效日期,允许单独对附件进行更新。

PURPOSE 目的 The aim of these Explanatory Notes is to guide the manufacturer of medicinal products in the preparation of a Site Master File that is useful to the regulatory authority in planning and conducting GMP inspections. 3 本说明的目的是指导医药生产厂家进行 SMF 的编写。

SMF 在监管机构进行 GMP 审查计划和执 行 GMP 审查中是有用的。

SCOPE 适用范围 These Explanatory Notes apply to the preparation and content of the Site Master File. Manufacturers should refer to regional / national regulatory requirements to establish whether it is mandatory for manufacturers of medicinal products to prepare a Site Master File. 4 本说明使用与 SMF 的编写及内容。

厂家应参考地区/国家法规要求以确定是否强制要求医药用 品厂家编写 SMF。

These Explanatory Notes apply for all kind of manufacturing operations such as production, packaging and labelling, testing, relabelling and repackaging of all types of medicinal products. The outlines of this guide could also be used in the preparation of a Site Master File or corresponding document by Blood and Tissue Establishments and manufacturers of Active Pharmaceutical Ingredients. 本说明适用于下述此类生产操作:所有类型医药产品的生产、包装和贴标、检验、再贴标和再 包装 本指南的大纲也可以用于编写 SMF 或 API 血液和组织制造机构以及生产厂家相关文件的编写 。

5 CONTENT OF SITE MASTER FILE SMF内容 Refer to Annex for the format to be used. SMF 格式见附件。

2011 PIC/S 工厂主文件指南 6 REVISION HISTORY 修订历史 Date 日期 1 November 2002 2002 年 11 月 1 日 Version Number 版本号 PE 0081 Revision of format (in line with SOP on SOPs) and introduction; delete reference to the Site Master File as being Part B of the PIC/S inspection report; new point C.5.3 on reprocessing/rework; better distinction between Quality Assurance and Quality Control; explanation of abbreviations; minor editorial changes. All changes adopted at PIC/S Committee meeting on 8 October 2002. 格式(与 SOP 一致)及简介修订;取消将 SMF 作为 PIC/S 审查报告的B部;C.5.3 再加工 /返工的新要点;质量保证和质量控制的进一步 区分;缩略词的解释;小幅编辑修改。

所有变更 均在 PIC/S 2002 年 10 月 8 日召开的会议上 被采用。

1 July 2004 2004 年6月 1 日 25 September 2007 2007 年9月25 日 1 January 2011 2011 年1月1日 PE 0082 Change in the Editor’s coordinates 编者协调变更 Change in the Editor’s coordinates PE 0083 编者协调变更 Simplification of the document and implementation of requirements related to quality risk assessment policy 简化文件以及质量风险评估政策相关要求的 执行 PE 0084 Annex to PE 0084 CONTENT OF SITE MASTER FILE 现场主文件内容 1 GENERAL INFORMATION ON THE MANUFACTURER 工厂一般信息

2011 PIC/S 工厂主文件指南 1.1 Contact information on the manufacturer 生产商联系信息 — Name and official address of the manufacturer; — — 生产商名称和办公地址; Names and street addresses of the site, buildings and production units located on the 厂址名称和街道地址、厂内建筑和生产单元的名称; site; — — Contact information of the manufacturer including 24 hrs telephone number of the contact personnel in the case of product defects or recalls; — 生产商联系信息,包括产品缺陷或召回时联系人的 24 小时电话号码; — Identification number of the site as e.g. GPS details, DUNS (Data Universal Numbering System) Number (a unique identification number provided by Dun & Bradstreet) of the site or any other geographic location system. — 工厂识别信息,如全球定位信息(GPS 信息)或其他的地理定位系统,以及邓氏编号。

Authorised pharmaceutical manufacturing activities of the site. 授权的药物生产活动 — Copy of the valid manufacturing authorisation issued by the relevant Competent Authority in Appendix 1; or when applicable, reference to the EudraGMP database. If the Competent Authority does not issue manufacturing authorisations, this should be stated; 1.2 — 在附件 1 中,附上相关主管颁发的有效生产许可证的复件;或者可能的话,引用欧 洲 GMP 数据库;如果主管不颁发生产许可证,这应该加以说明。

— Brief description of manufacture, import, export, distribution and other activities as authorised by the relevant Competent Authorities including foreign authorities with authorised dosage forms/activities, respectively; where not covered by the manufacturing authorisation; — 药政机构许可的生产、进口、出口、分销和其他活动的简要描述,包括生产许可证上没 有的国外许可的剂型/活动; — Type of products currently manufactured onsite (list in Appendix 2) where not covered by Appendix 1 or the EudraGMP database; — 准入中 目前在厂生产的产品类型(在附件 2 中列出),如果未被包含在附件 1 中或欧洲 GMP — List of GMP inspections of the site within the last 5 years; including dates and name/country of the Competent Authority having performed the inspection. A copy of current GMP certificate (Appendix 3) or reference to the EudraGMP database should be included, if available. — 列出过去 5 年的现场 GMP 检查清单,包括日期和进行检验的药政机构的名称/国家。

如 果有,应当现行的 GMP 证书(附件 3)或引用欧洲 GMP 数据库中的副本。

1.3 Any other manufacturing activities carr out on the site 厂区内进行的任何其他生产活动

2011 PIC/S 工厂主文件指南 — — 2 系 Description of nonpharmaceutical activities onsite, if any. 如果有的话,描述厂区内的非制药活动。

QUALITY MANAGEMENT SYSTEM OF THE MANUFACTURER 公司的质量管理体 The quality management system of the manufacturer 公司质量管理 — Brief description of the quality management systems run by the company and reference to the standards used; 2.1 — 公司质量管理运行系统的简要说明和所参考的标准; — Responsibilities related to the maintaining of quality system including senior management; — 包括高级管理层在内的质量维护职责; — Information of activities for which the site is accredited and certif, including and content of accreditations, name of accrediting bodies. — 公司认证的活动信息,包括日期和认证内容,认证机构名称。

Release procedure of finished products 最终产品放行程序 — Detailed description of qualification requirements (education and work experience) of the Authorised Person(s) / Qualif Person(s) responsible for batch certification and releasing procedures; 2.2 — 负责批量证明和放行程序的授权人/有资质人(简称:QP)的资格要求(教育/工作经验) 的详细说明; — — General description of batch certification and releasing procedure; 批合格和放行过程的一般描述; — Role of Authorised Person / Qualif Person in quarantine and release of finished products and in assessment of compliance with the Marketing Authorisation; — 授权人/有资质人(简称:QP)在待验、放行最终产品、上市授权符合性评估中的角色。

— The arrangements between Authorised Persons / Qualif Persons when several Authorised Persons / Qualif Persons are involved; — 涉及到多个授权人/有资质人时,他们之间的安排 — Statement on whether the control strategy employs Process Analytical Technology (PAT) and/or Real Time Release or Parametric Release. — 采用 PAT(过程分析技术)控制策略和/或实时放行或参数放行的描述 2.3 Management of suppliers and contractors 承包商和商的管理

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