Sterile Manufacturing: Regulations, Processes, and Guidelines

دانلود کتاب Sterile Manufacturing: Regulations, Processes, and Guidelines

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کتاب ساخت استریل: مقررات، فرآیندها و دستورالعمل ها نسخه زبان اصلی

دانلود کتاب ساخت استریل: مقررات، فرآیندها و دستورالعمل ها بعد از پرداخت مقدور خواهد بود
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توضیحاتی در مورد کتاب Sterile Manufacturing: Regulations, Processes, and Guidelines

نام کتاب : Sterile Manufacturing: Regulations, Processes, and Guidelines
ویرایش : 1
عنوان ترجمه شده به فارسی : ساخت استریل: مقررات، فرآیندها و دستورالعمل ها
سری :
نویسندگان :
ناشر : CRC Press
سال نشر : 2021
تعداد صفحات : 207
ISBN (شابک) : 9780367754358 , 0367754355
زبان کتاب : English
فرمت کتاب : pdf
حجم کتاب : 11 مگابایت



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فهرست مطالب :


Cover\nHalf Title\nTitle Page\nCopyright Page\nTable of Contents\nPreface\nAcknowledgment\nAuthor Bio\nChapter 1 Introduction\nChapter 2 Data Integrity Compliance\n Process/Procedure – Inventory of Systems\n Process/Procedure – Determination of 21 CFR Part 11 / Data Integrity Applicability\n Process/Procedure – 21 CFR Coverage Assessment\n Process/Procedure – 21 CFR Part 11 / Data Integrity Gap Analysis\nChapter 3 Risk-Based Life Cycle Management\n Process Flow Diagram\n Essential Requirements (Requirements List)\n Linkage Document (Trace Matrix) – Historical Document\n Process Failure Mode and Effects Analysis\n Control Plan\n Assessment of Process Flow Diagram/pFMEA/Control Plan Documents\n Assessment of Test Method Validation Documents\n Assessment of Process Validation and Manufacturing Instruction Documents\n Product Performance Data\n Production Process Data Collection (PPDC)\n Assessment of Risk Controls (Control Strategy)\n Maintaining “Living Documents” Updates to the Playbook Documentation\n Document Management\n Playbook Updates/Approvals (Live System)\n RBLCM Data Collection\nChapter 4 FMEA Manufacturing Procedure\nChapter 5 Classified Areas\nChapter 6 Sterile Manufacturing Facilities\nChapter 7 Personnel behaviors, Personal Protective Equipment (PPE), and Process Flow\nChapter 8 Quality Approach for Systems Validation\nChapter 9 Dedicated Facilities\nChapter 10 Contamination\nChapter 11 Containment\nChapter 12 Suppliers\nChapter 13 Single-Use Technologies (SUT)\nChapter 14 Master Qualification Plan\n Risk Assessment\n Design Review/Design Qualification\n Commissioning and Qualification\n Documentation\n Commissioning Process\n Qualification Process\n Vendor Documentation\n Qualification Supporting Systems\n Acceptance and Release\n Maintenance\n Decommissioning\n Legacy Systems\nChapter 15 Water For Injection (WFI)\n Process Description\n Specifications\n Lifecycle Requirements\n Product and Process User Requirements\n Product Description\n Operating Ranges\n Material of Construction\n Metallics:\n Plastics:\n Elastomers:\n Glass:\n Welding Requirements\n Construction Requirements\n Lubrication Requirements\n Electrical Requirements\n Safety Requirements\n Operational Requirements\n Process Constraints and Limitations\n Process Control System\n Operator Interface\n Power Loss and Recovery\n Cleaning and Sanitizing\n Maintenance Requirements\n Training and Documentation Requirements\nChapter 16 Integrated Facility Design\nChapter 17 Sterile Techniques\nChapter 18 Compliance\n I – Design, Construction, and Installation Phase\n II – Execution and Qualification Phase\nChapter 19 Controls\n Lifecycle Requirements\n Product Quality Requirements\n Process Parameter Requirements\n System Boundaries and Requirements\n Critical parameter controls\n Electronic Batch Records (EBR)\nChapter 20 Barriers and Isolators\n Isolator design considerations\nChapter 21 Quality Risk Management\nChapter 22 Equipment Qualification (EQ)\nChapter 23 Process Validation\nChapter 24 Change Control\nChapter 25 Analytical Testing of Raw Material Quality\nChapter 26 Product Life Cycle\nChapter 27 Quality by Design (QbD)\n Design-Based Control Strategies\n Global Harmonization Task Force\nChapter 28 Sterilization\nChapter 29 Cleaning Validation\nChapter 30 Lyophilization\n INTRODUCTION\n Lyophilization Cycle Development\n REFERENCES\nReferences\nGlossary\nBibliography\nAppendix I: System-Level Impact Assessment\nAppendix II: Instrument Criticality Assessment\nAppendix III: Required Testing (ISO 14644-2)\nAppendix IV: Contract Manufacturing Process Steps\nAppendix V: Equipment Qualification\nAppendix VI: API terms\nAppendix VII: Impurities – FDA Directive\nAppendix VIII: Master Qualification Plan (MQP) – Template\nAppendix IX: High-Level Risk Analysis – Template\nAppendix X: Cleaning Validation\nIndex




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