Equipment qualification in the pharm...
Ostrove, Steven A.,

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  • Equipment qualification in the pharmaceutical industry
  • 紀錄類型: 書目-電子資源 : Monograph/item
    正題名/作者: Equipment qualification in the pharmaceutical industry/ Steven Ostrove.
    作者: Ostrove, Steven A.,
    出版者: London :Academic Press, : 2019.,
    面頁冊數: 1 online resource :col. ill.
    內容註: Front Cover; Equipment Qualification in The Pharmaceutical Industry; Copyright; Dedication; Contents; Acknowledgments; Introduction to aspects in pharmaceutical manufacturing; Chapter One: Introduction; Compliance; Qualification; Validate/validation; Types of qualification; The order of the qualification process; Chapter Two: Getting ready: Documentation; Overview; Documentation; Document specifics; Validation master plan; Drawings; Manuals; SOPs; Operations/vendors/others; Summary; Chapter Three: Quality systems; Quality risk management; Change control; Investigations
    內容註: Corrective action-Preventive actionCalibration/metrology; Preventive maintenance; Cleaning; Document control; Re-qualification; Chapter Four: Equipment design considerations; Materials of construction; Location; Cleaning and maintenance; Other considerations; Chapter Five: Equipment controls and automation; Structural qualification; Functional qualification; Black box, gray box, white box qualifications; IQ/OQ for computer or automated systems; Part 11; Summary; Chapter Six: Preparing the protocols: General approach; Protocol development; Layout; Stand-alone conditions; Acceptance criteria
    內容註: Protocol reviewChapter Seven: Commissioning and decommissioning; FAT and SAT; Commissioning; Using commissioning data; Decommissioning; Chapter Eight: Equipment qualification protocols; Product contact; Criticality; Safety; System suitability; Environmental conditions; Protocols; Installation qualification; Operational qualification; Performance qualification; Protocol review; Chapter Nine: Equipment checklists; Chapter Ten: Protocol execution; Prioritization; Good documentation practices; Test instruments; Putting it all together; First steps; Second steps; Third steps
    內容註: Handling deviations in the protocolPoints to remember; Summary of protocol execution; Chapter Eleven: Protocol reports; Preparing the report; Each section; Approval page; Purpose/scope; Conclusions; Results; Discussion; Deviations log; Appendix A: Definitions and abbreviations; Appendix B: Preparing a Qualification Protocol; Appendix C : References; Index; Back Cover
    標題: Pharmaceutical technology - Quality control. -
    電子資源: https://www.sciencedirect.com/science/book/9780128175682
    ISBN: 9780128175699 (electronic bk.)
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