Principles of Parenteral Solution Validation

A Practical Lifecycle Approach
 
 
Elsevier (Verlag)
  • 1. Auflage
  • |
  • erschienen am 29. November 2019
  • |
  • 298 Seiten
 
E-Book | ePUB mit Adobe DRM | Systemvoraussetzungen
E-Book | PDF mit Adobe DRM | Systemvoraussetzungen
978-0-12-809446-4 (ISBN)
 

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area.

  • Discusses international and domestic regulatory considerations in every section
  • Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs
  • Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more
  • Englisch
  • Saint Louis
  • |
  • USA
  • 4,64 MB
978-0-12-809446-4 (9780128094464)
weitere Ausgaben werden ermittelt
  • Front Cover
  • Principles of Parenteral Solution Validation
  • Copyright Page
  • Dedication
  • Contents
  • List of Contributors
  • Editor Biographies
  • About the Expertise in Pharmaceutical Process Technology Series
  • Format
  • Subject Matter
  • Target Audience
  • Introduction
  • References
  • Further Reading
  • 1 Process Validation: Design and Planning
  • Part 1: Background-The Need for Process Understanding
  • Why Is Aseptic Process Validation so challenging?
  • Process Validation, Process Capability, and Process Control
  • Role of Process Understanding
  • Process Life Cycle Approach
  • Proper Process Design as the Key to Process Performance Assurance: Sterility by Design
  • Using a Line of Sight Approach
  • Defining Process Requirements
  • The Role of Process Design and Planning in Validation: Basis of Design
  • Timely User Requirement Specification
  • Equipment and Facility Qualification
  • Mapping the Process
  • Periodic Assessment and Requalification
  • Aseptic Practices: A Key Element in the Validation of Aseptic Processes
  • First Air Principles
  • References
  • 2 Aseptic Process Validation: Aseptic Process Simulation Design
  • Microbial Contamination Case Study: Sterile Vessel Holding Qualification
  • Question #1: How Did the Interior of the Vessel Become Contaminated?
  • The More Challenging Question Is #2: If the Conclusions Are Correct, Then Why Did the Initial Media Fills Pass?
  • Aseptic Process Simulation Study Design
  • Aseptic Process Simulations Performance Schedule and Frequency
  • Media Fills Run Number
  • Inclusion of Process Steps
  • "Worst-Case" Parameters or Conditions
  • Fill Volume
  • Duration
  • Interventions
  • Intervention Evaluation and Risk Assessment Methods
  • Incubation
  • Growth Promotion Studies
  • Preincubation Inspection and Rejection
  • Postincubation Inspection
  • Acceptance Criteria
  • Filled Unit Accountability
  • Failure Investigation
  • Aborted and Invalid Media Fills
  • Special Considerations
  • Powder Filling
  • Ointment Filling
  • Lyophilized Product Filling
  • Anaerobic Processes
  • Conclusion
  • References
  • 3 Quality Risk Management of Parenteral Process Validation, Part 1: Fundamentals
  • Quality Risk Management and Process Validation
  • Overview: Risk Management Evolution
  • Principles of Risk Management and the Quality Risk Management Life Cycle
  • Risk: Understanding Hazard, Harm, and Controls
  • Risk Management: The Fine Print
  • Risk Team Membership
  • Goal, Scope, and Boundaries
  • Exploring the Process Map
  • The Risk Question and Tool Selection
  • Scales for Assessing Risk
  • Quality Risk Management Life Cycle
  • Risk Assessment
  • Risk Control
  • Risk Communication
  • Risk Review
  • Conclusion
  • References
  • 4 Equipment Cleaning Process
  • Establishing Limits
  • References
  • Further Reading
  • 5 Quality Risk Management of Parenteral Process Validation, Part 2: A Risk-Based Quality Management System
  • Overview
  • Deviation Management
  • Low Risk Deviation
  • Medium Risk Deviation
  • High Risk Deviation
  • Corrective and Preventive Action
  • Risk Benefit Analysis
  • Change Control
  • Change Control and Corrective and Preventive Action Effectiveness Monitoring
  • Self-Inspection Process
  • Define Key Quality Management Systems
  • Define Functional Area Categories
  • Perform Risk Assessment Using Compliance Scoring Criteria
  • Risk Factors and Scoring
  • Determine Audit Frequency Using Risk Matrix
  • Develop Audit Schedule
  • Review Annually
  • Summary
  • References
  • Further Reading
  • 6 Use of Statistics in Process Validation
  • Overview
  • Use of Statistics in Parenteral Process Validation-Ten Basic Concepts
  • First Concept-A Concept of Statistical Inference
  • Second Concept-Graph It First!
  • Third Concept-Let DataTalk to You!
  • Fourth Concept-Normality?
  • Fifth Concept-Descriptive Statistics
  • Sixth Concept-Control Charting
  • Seventh and Eight Concepts-Tolerance and Capability
  • Ninth Concept-Hypothesis Testing
  • Tenth Concept-Design of Experiments
  • Conclusion
  • References
  • Further Reading
  • 7 Process Validation Stage 1: Parenteral Process Design
  • Introduction Into Pharmaceutical Development
  • Master Planning, Organization, and Schedule Planning
  • Risk/Impact Assessment
  • Process/System Design
  • Perform Risk Assessment (Identification of Critical Quality Attributes and Critical Process Parameters)
  • Design of Experiments
  • Developing Control Strategies and Determine Process Design
  • Scale-Up and Technology Transfer
  • Stage 1: Design of Experiments Case Study
  • Final Notes About Stage 1 Process Design
  • References
  • 8 Process Validation Stage 2: Parenteral Process Performance Qualification
  • General Principles of Stage 2 Life Cycle Approach to Process Validation for Parenteral Products
  • The Line of Sight Approach to Process Understanding and Process Validation
  • Stage 2: Process Qualification
  • Some Points to Consider for the Qualification of Equipment and Systems
  • Critical Utilities
  • Clean Rooms and Classified Areas
  • Component Preparation
  • Product Sterilization and Filtration
  • Moist Heat Sterilization
  • Dry Heat Sterilization
  • Radiation and Ethylene Oxide
  • Sterile Filtration
  • Filling Equipment and Systems
  • Inspection, Labeling, and Secondary Packaging Systems
  • Lyophilization
  • Material Storage, Handling, and Transport
  • Testing Laboratories
  • Additional Parenteral Processes
  • Cleaning Validation
  • Computer System Validation
  • Terminal Sterilization
  • Container Closure Integrity
  • Periodic Assessment and Requalification
  • Stage 2b-PPQ or Process Performance Qualification
  • Number of Batches
  • Conclusion
  • References
  • Further Reading
  • 9 Process Validation Stage 3: Continued Process Verification
  • Introduction
  • Definitions Typically Used in Process Validation
  • Determining When Continued Process Verification Starts
  • Legacy Systems Versus New Systems
  • Continued Process Verification Strategy and Enhanced Sampling
  • Maintenance of Validation and Change Control, and Periodic Assessment
  • Develop Control Rules for Continued Process Verification
  • Develop Strategies for Continued Process Verification
  • Examples of Case Study Evaluations for Parenteral Products
  • Conclusion
  • References
  • 10 Preuse/Poststerilization Integrity Testing of Sterilizing Grade Filter
  • Introduction
  • Possible Reasons to Apply Preuse/Poststerilization Integrity Testing
  • The Risks Attached to Preuse/Poststerilization Integrity Testing
  • Recommendations
  • References
  • 11 Environmental Monitoring
  • References
  • Further reading
  • 12 Isolators
  • Further Reading
  • 13 Post Aseptic Fill Sterilization and Lethal Treatment
  • Introduction
  • Sterilization and Lethal Treatment
  • Post Aseptic Fill Sterilization
  • Post Aseptic Fill Lethal Treatment
  • Parametric Release
  • Summary
  • Conclusion
  • Index
  • Back Cover

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