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  • What is GAMP®? | ISPE | International Society for Pharmaceutical . . .
    GAMP® Guidance Documents Good Automated Manufacturing Practice (GAMP®), is a technical sub-committee of the International Society for Pharmaceutical Engineering (ISPE) The goal of this committee is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry
  • GAMP® | ISPE | International Society for Pharmaceutical Engineering
    GAMP ® Guidance Documents GAMP® is a technical sub-committee of the International Society for Pharmaceutical Engineering (ISPE) The goal of this committee is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry The GAMP committee organizes training guides for its members
  • GAMP 5 Guide 2nd Edition | ISPE | International Society for . . .
    Maintaining the principles and framework of the First Edition, GAMP® 5 (Second Edition) is newly revised and expanded to address the increased importance of service providers, evolving approaches to software development, and the more widespread use of software tools and automation It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate approaches
  • The Importance of GAMP® in the Pharmaceutical Industry
    Conclusion GAMP guidance is essential for ensuring the quality, safety, and compliance of pharmaceutical products By adhering to GAMP guidance and participating in ISPE training events, professionals can stay informed and equipped to navigate the complexities of automated manufacturing in the pharmaceutical industry
  • GAMP Good Practice Guides | ISPE | International Society for . . .
    This GAMP Good Practice Guide conforms to GAMP® 5 standards and terminology and reflects ICH Q8, Q9, and Q10, Quality by Design, and Process Analytical Technology principles
  • What You Need to Know About GAMP® 5 Guide, 2nd Edition
    ISPE’s GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) (GAMP® 5 Guide, 2nd Edition) maintains the principles and framework of the first edition and updates their application in the modern world, including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and automation The
  • GAMP® 5 Second Edition is Here! | Pharmaceutical Engineering - ISPE
    GAMP® 5 Second Edition is here! Since its publication, GAMP® 5 has been far and away the leading international guidance on GxP computerized systems validation and compliance, and it was time to update our guidance to reflect technological progress
  • Updated GAMP® GPG Incorporates AI and Open-Source Software
    The landscape of clinical trials has been transformed in a post-pandemic world In July, ISPE released the second edition of ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice It addresses managing complexities associated with decentralized clinical trials, the benefits and challenges of using open-source software, and more
  • Guidance Documents | ISPE | International Society for Pharmaceutical . . .
    GAMP ® guidance aims to safeguard patient safety, product quality, and data integrity in the use of GxP computerized systems It aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements by building upon existing industry good practice in an efficient and effective manner
  • A GAMP® Approach to Computerized System Life Cycle and IT Process . . .
    Conclusion GAMP guidance makes a valuable distinction between GxP records supporting the medical product life cycle and required by a predicate rule, and non-GxP information, data, and artifacts that support computerized system life cycles and IT processes





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