作业帮翻译!~~~~~不要翻译器翻得!~~~~高手来
来源：学生作业帮 编辑：作业帮 分类：英语作业 时间：2024/05/10 12:55:02
翻译!~~~~~不要翻译器翻得!~~~~高手来
The mandatory minimum requirements for Pfizer Global Manufacturing (PGM) Sites and Center Functions.
Provide ONE Pfizer Quality Standard to all PGM Sites for Production and control of
–Active Pharmaceutical Ingredients
–Drug Products
–Medical Devices
–Biologics
–Consumer Health Products
–Nutritionals
Organized using a Quality Systems Approach into seven Systems
–Quality (Q1200-Q1999)
–Facilities and Equipment (FE2100 – FE2199)
–Materials (M3100 – M3199)
–Production (P4100 – P4199)
–Packaging and Labeling (PL5100 – PL5199)
–Laboratory (L6100 – L6199)
–Validation (V7100 – V7199)
Pfizer Quality Standards = Single document with Policy Standards and Practice Standards
On the Effective Date
The Compliance Analysis Status (CAS) report and Plan of Action to bring the Site into compliance with the PQS requirements are to be completed
Approval Page
Identifies the PQS signatories as well as approval and effective dates
Policy Standards
Describe What Is Required
Labeled Alphabetically in Section I
Practice Standards
Describe How to Accomplish What Is Required and Provide Links to their Associated Policy Standard(s)
Labeled Numerically in Section II
Optional Practice Standards
Offer Alternative yet Compliant Ways to Accomplish Certain Requirements
Regulatory Exceptions
Highlight Some Key Areas in Which Local
(e.g., Country, Region, State) Requirements Exceed or Otherwise Differ Significantly From Those of a PQS
Regulatory Exceptions
References
Include other PQSs, Policy Memos (PM), and industry standards and guidance documents that are related to or were used in the development of the PQS.
Glossary A: Acronyms
Acronyms - Define Abbreviated Terms
Maintained as a separate supporting document
Commonly referred to as the Master Acronym List (MAL)
Glossary B: Terms & Definitions
Terms and Definitions -
Define Key Terms and the PQSs that contain them
Maintained in a separate supporting document
Commonly referred to as the Master Glossary
Regulatory Extracts
Provide Specific Regulatory Abstracts That Relate to Each Individual PQS
Each extract is a small excerpt of regulatory text that is the basis for the Policy or Practice.
Other Related Documents
–Policy Memos (PMs) enable rapid communication of policies that need to be immediately implemented. They are issued to address a specific compliance or business need. They may become part of new or existing PQSs or serve a limited purpose and then become obsolete.
–Good Practice Bulletins (GPBs) not defined in PQS Q1225. They contain nonbinding guidance information which represents one way to be compliant with some PQS requirements. They are linked to all applicable PQSs and GPBs in PDOCS.
The mandatory minimum requirements for Pfizer Global Manufacturing (PGM) Sites and Center Functions.
Provide ONE Pfizer Quality Standard to all PGM Sites for Production and control of
–Active Pharmaceutical Ingredients
–Drug Products
–Medical Devices
–Biologics
–Consumer Health Products
–Nutritionals
Organized using a Quality Systems Approach into seven Systems
–Quality (Q1200-Q1999)
–Facilities and Equipment (FE2100 – FE2199)
–Materials (M3100 – M3199)
–Production (P4100 – P4199)
–Packaging and Labeling (PL5100 – PL5199)
–Laboratory (L6100 – L6199)
–Validation (V7100 – V7199)
Pfizer Quality Standards = Single document with Policy Standards and Practice Standards
On the Effective Date
The Compliance Analysis Status (CAS) report and Plan of Action to bring the Site into compliance with the PQS requirements are to be completed
Approval Page
Identifies the PQS signatories as well as approval and effective dates
Policy Standards
Describe What Is Required
Labeled Alphabetically in Section I
Practice Standards
Describe How to Accomplish What Is Required and Provide Links to their Associated Policy Standard(s)
Labeled Numerically in Section II
Optional Practice Standards
Offer Alternative yet Compliant Ways to Accomplish Certain Requirements
Regulatory Exceptions
Highlight Some Key Areas in Which Local
(e.g., Country, Region, State) Requirements Exceed or Otherwise Differ Significantly From Those of a PQS
Regulatory Exceptions
References
Include other PQSs, Policy Memos (PM), and industry standards and guidance documents that are related to or were used in the development of the PQS.
Glossary A: Acronyms
Acronyms - Define Abbreviated Terms
Maintained as a separate supporting document
Commonly referred to as the Master Acronym List (MAL)
Glossary B: Terms & Definitions
Terms and Definitions -
Define Key Terms and the PQSs that contain them
Maintained in a separate supporting document
Commonly referred to as the Master Glossary
Regulatory Extracts
Provide Specific Regulatory Abstracts That Relate to Each Individual PQS
Each extract is a small excerpt of regulatory text that is the basis for the Policy or Practice.
Other Related Documents
–Policy Memos (PMs) enable rapid communication of policies that need to be immediately implemented. They are issued to address a specific compliance or business need. They may become part of new or existing PQSs or serve a limited purpose and then become obsolete.
–Good Practice Bulletins (GPBs) not defined in PQS Q1225. They contain nonbinding guidance information which represents one way to be compliant with some PQS requirements. They are linked to all applicable PQSs and GPBs in PDOCS.
对辉瑞公司全球制造（PGM）中的工厂和中心功能单位的最低强制性要求.
提供一套辉瑞公司的质量标准给所有生产和控制以下产品的PGM：
- 原料药
- 药品
- 医疗器械
- 生物制品
- 消费者保健产品
- 营养品
有组织地使用质量管理体系方法,分为七个系统
- 质量（Q1200- Q1999）
- 设施和设备（FE2100 - FE2199）
- 材料（M3100 - M3199）
- 生产（P4100 - P4199）
- 包装和标签（PL5100 - PL5199）
- 实验室（L6100 - L6199）
- 验证（V7100 - V7199）
辉瑞公司的质量标准=包含政策标准和实践标准的单个文档
在生效日期
相符性分析状态（CAS）报告,以及使工厂符合PQS要求的行动计划应该完成
批准页
标识PQS签署以及批准和生效日期
政策标准
描述什么是所需要的
在第一节按字母顺序标记
规范标准
描述如何完成所需事项,并提供连结到相关的政策标准
在第二节按字母顺序标记
可选的规范标准
提供完成某些要求的替代而仍相符的方式
法规例外条款
突出说明一些关键地区,其当地（如国家,地区,州）的要求超出或者明显有别于PQS的要求
法规例外条款
参考文献
列出与PQS相关的、或在PQS开发过程中使用到的其他PQS、政策备忘录（PM）、行业标准和指导性文件.
词汇表A：缩略语
缩略语 - 定义缩略语
维持一个单独的支持文件
通常可归到主缩略语表（MAL）
词汇表B：术语和定义
术语和定义 -
定义关键的术语和包含它们的PQS
维持一个单独的支持文件
通常可归到主词汇表
法规摘录
提供涉及到每一个PQS的特定法规摘要
每个摘要都是法规文本的一个小引用,作为政策或实践的基础.
其他相关文件
- 政策备忘录（PMS）使需要立即实施的政策能快速沟通.发出这些备忘录以解决特定法规或业务需要.他们有可能成为新的或现有PQS的一部分,或服务于一个有限的目的、然后作废.
- PQS Q1225中并没有定义良好规范公报（GPB）.它们含有不具约束力的指导信息,是指出符合某些PQS要求的途径之一.它们与所有在PDOCS中适用的PQS及GPB相链接.
提供一套辉瑞公司的质量标准给所有生产和控制以下产品的PGM：
- 原料药
- 药品
- 医疗器械
- 生物制品
- 消费者保健产品
- 营养品
有组织地使用质量管理体系方法,分为七个系统
- 质量（Q1200- Q1999）
- 设施和设备（FE2100 - FE2199）
- 材料（M3100 - M3199）
- 生产（P4100 - P4199）
- 包装和标签（PL5100 - PL5199）
- 实验室（L6100 - L6199）
- 验证（V7100 - V7199）
辉瑞公司的质量标准=包含政策标准和实践标准的单个文档
在生效日期
相符性分析状态（CAS）报告,以及使工厂符合PQS要求的行动计划应该完成
批准页
标识PQS签署以及批准和生效日期
政策标准
描述什么是所需要的
在第一节按字母顺序标记
规范标准
描述如何完成所需事项,并提供连结到相关的政策标准
在第二节按字母顺序标记
可选的规范标准
提供完成某些要求的替代而仍相符的方式
法规例外条款
突出说明一些关键地区,其当地（如国家,地区,州）的要求超出或者明显有别于PQS的要求
法规例外条款
参考文献
列出与PQS相关的、或在PQS开发过程中使用到的其他PQS、政策备忘录（PM）、行业标准和指导性文件.
词汇表A：缩略语
缩略语 - 定义缩略语
维持一个单独的支持文件
通常可归到主缩略语表（MAL）
词汇表B：术语和定义
术语和定义 -
定义关键的术语和包含它们的PQS
维持一个单独的支持文件
通常可归到主词汇表
法规摘录
提供涉及到每一个PQS的特定法规摘要
每个摘要都是法规文本的一个小引用,作为政策或实践的基础.
其他相关文件
- 政策备忘录（PMS）使需要立即实施的政策能快速沟通.发出这些备忘录以解决特定法规或业务需要.他们有可能成为新的或现有PQS的一部分,或服务于一个有限的目的、然后作废.
- PQS Q1225中并没有定义良好规范公报（GPB）.它们含有不具约束力的指导信息,是指出符合某些PQS要求的途径之一.它们与所有在PDOCS中适用的PQS及GPB相链接.