ISPE 制药与生物技术术语表 2008 ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Disclaimer:

This Glossary is meant to assist individuals in the pharmaceutical and biotechnology industries. ISPE cannot ensure the

complete accuracy of the content in this Glossary and assumes no responsibility for errors or omissions.

This PDF is an export of terms found in the ISPE Glossary of Pharmaceutical and Biotechnology Terminology as of August

2008. The most up-to-date data can be found at www.ISPE.org/glossary.

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ISPE Glossary of

Pharmaceutical and

Biotechnology Terminology

August 2008

The ISPE Glossary of Pharmaceutical and Biotechnology Terminology is the result of many years of gathering material from

sources such as scientic journals, industrial magazines, professional organizations, the world wide web, industry seminars,

company guides, vendor and manufacturer information, national and international codes, and diverse individuals. This

compilation of abbreviations, acronyms, and terminology for the relatively is a reference for engineers, designers, technicians,

owners, contractors, and others in the pharmaceutical and biopharmaceutical industries. It includes terms used in water

treatment, welding, metallurgy, medicine, biology, chemistry, computer technology, manufacturing processes, HVAC, etc.

The Glossary includes terms from the following sources:

• American Society of Mechanical Engineers (ASME), Bioprocessing Equipment (BPE), 2002 Revision

• Committees on Human research

• FDA Glossary of Computerized System and Software Development Technology

• GAMP® 4, Good Automated Manufacturing Practice Guide for Validation of Automated Systems

• GAMP® Good Practice Guides

• ICH Harmonised Tripartite Guide “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” Q7a

• ISO/TC209 Working Groups at 2001-03-31 – Committee Draft ISO/CD 14644-6 “Cleanrooms and associated controlled

environments” – Part 6: Terms and Denitions

• ISPE Baseline® Guides for New and Renovated Facilities

• ISPE Good Practice Guides

• Rules and Guidance for Pharmaceutical Manufacturers and Distributors. Medicines Control Agency (MCA)

This PDF is an export of terms found in the ISPE Glossary of Pharmaceutical and Biotechnology Terminology as of August

2008. The most up-to-date data can be found at www.ISPE.org/glossary.

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标签： #术语 #ISPE

摘要：

本页面提供ISPE（国际制药工程协会）发布的2008版《制药与生物技术术语表》的专业内容解读。该术语表是制药与生物技术行业公认的权威参考工具，涵盖了从原料药生产、制剂开发、质量管理到生物工艺工程等领域的标准化定义与专业词汇。对于从事药品研发、生产、法规合规及工程设计的技术人员而言，掌握这些术语是确保国际交流一致性与符合GMP（良好生产规范）要求的基础。本内容旨在帮助读者快速理解该术语表的核心价值，提升对复杂制药与生物技术概念的专业认知，适用于企业内部培训、文档撰写及跨部门协作场景。

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