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跪求!高手翻译!~~~不要翻译器之类的~~~~

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跪求!高手翻译!~~~不要翻译器之类的~~~~
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.
Pfizer全球生产场及功能中心的必备最低要求
Provide ONE Pfizer Quality Standard to all PGM Sites for Production and control of
为所有Pfizer全球生产场的生产提供统一(ONE大写了,不知是否是特殊词组的缩写)Pfizer质量标准,并控制
–\x05Active Pharmaceutical Ingredients 活性药物原料
–\x05Drug Products 成药产品
–\x05Medical Devices 医疗器械
–\x05Biologics 生物制品
–\x05Consumer Health Products 保健消费品
–\x05Nutritionals 营养品
Organized using a Quality Systems Approach into seven Systems
由一套质检系统组织为7个子系统
–\x05Quality (Q1200-Q1999) 质量(Q1200-Q1999)(括号里的好像是型号,不翻了)
–\x05Facilities and Equipment (FE2100 – FE2199) 仪器器材
–\x05Materials (M3100 – M3199) 原料
–\x05Production (P4100 – P4199) 生产
–\x05Packaging and Labeling (PL5100 – PL5199) 包装加签
–\x05Laboratory (L6100 – L6199) 实验室
–\x05Validation (V7100 – V7199) 批准确认
Pfizer Quality Standards = Single document with Policy Standards and Practice Standards
Pfizer质检标准 = 包含政策标准和实际操作标准的单一文件
On the Effective Date 在生效日期时
\x05The Compliance Analysis Status (CAS) report and Plan of Action to bring the Site into compliance with the PQS requirements are to be completed
须完成可使生产场达到Pfrizer质检标准的达标分析情况报告和行动计划
Approval Page 批准页
Identifies the PQS signatories as well as approval and effective dates
认证Pfizer的签署方和批准及生效日期
Policy Standards 政策标准
Describe What Is Required 描述所需事宜
Labeled Alphabetically in Section I 在第一部分中按字母排序列出
Practice Standards 实际操作标准
Describe How to Accomplish What Is Required and Provide Links to their Associated Policy Standard(s)
描述如何达成所需事宜,并提供联至相关政策标准的链接
Labeled Numerically in Section II
在第二部分中按数字顺序列出
Optional Practice Standards 可选实际操作标准
Offer Alternative yet Compliant Ways to Accomplish Certain Requirements
提供达到某要求的可供另选且可达到要求的方法
Regulatory Exceptions 例外制度
Highlight Some Key Areas in Which Local
(e.g.,Country,Region,State) Requirements Exceed or Otherwise Differ Significantly From Those of a PQS
重点标出地方(国家、地区、州)的标准超出或与Pfizer质检标准有明显不同的重点项
References 参考资料
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.
包含相关或在构建Prizer质检标准时使用到的其他Pfizer质检标准,政策备忘录,行业标准和指导性文件
Glossary A:Acronyms 附录A:缩略词
Acronyms - Define Abbreviated Terms 缩略词 - 定义缩写的术语
Maintained as a separate supporting document 以分开的独立支持文件保存
Commonly referred to as the Master Acronym List (MAL) 通常称为主缩略词表
Glossary B:Terms & Definitions 附录B:术语及定义
Terms and Definitions - 术语及定义-
Define Key Terms and the PQSs that contain them 定义关键术语以及包含关键术语的Pfizer质检标准
Maintained in a separate supporting document 以分开的独立支持文件保存
Commonly referred to as the Master Glossary 通常称为主附录
Regulatory Extracts 规章提要
Provide Specific Regulatory Abstracts That Relate to Each Individual PQS
提供与各Pfrizer质检标准相关的各规章摘要
Each extract is a small excerpt of regulatory text that is the basis for the Policy or Practice.
每段提要是一小段规章文字的摘录,为政策或实践的基础.
Other Related Documents 其他相关文件
–\x05Policy 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.
- 政策备忘录用于须立即执行的政策的迅速沟通,为特定需遵守事由或商业需要而发布.可成为新的或现行的Pfizer质检标准的一部分,或达到有限目的后作废.
–\x05Good 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.
- 优秀操作公告栏未在(确定是not,不是now吗?如果是now,就是现在在,不是未在)Pfizer质检标准Q1225中定义,包含非强制性的指导性信息,代表可达到Pfizer质检标准的一种方法,与PDOCS中所有适用范围内的Pfizer质检标准和优秀操作公示相链接.