(Ebook) Pharmaceutical Process Scale Up A Plan for Total Quality Control from Manufacturer to Customer 5th Edition by Levin M ISBN 082474196X 9780824741969

(Ebook) Pharmaceutical Process Scale Up A Plan for Total Quality Control from Manufacturer to Customer 5th Edition by Levin M ISBN 082474196X 9780824741969

(Ebook) Pharmaceutical Process Scale Up A Plan for Total Quality Control from Manufacturer to Customer 5th Edition by Levin M - Ebook PDF Instant Download/Delivery: 082474196X, 9780824741969
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Product details:

ISBN 10: 082474196X 
ISBN 13: 9780824741969
Author: Levin M

The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes:

• New material on tableting scale-up and compaction.
• Regulatory appendices that cover FDA and EU Guidelines.
• New chapters on risk evaluation and validation as related to scale-up.
• Practical advice on scale-up solutions from world renowned experts in the field.

Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers. It will also provide interesting reading material for anyone involved in Process Analytical Technology (PAT), technology transfer and product globalization.

(Ebook) Pharmaceutical Process Scale Up A Plan for Total Quality Control from Manufacturer to Customer 5th Table of contents:

• 1. Introduction to Pharmaceutical Process Scale-Up

  • What is Scale-Up?

  • Importance of Scale-Up in Pharmaceutical Development

  • Challenges and Risks in Scale-Up

  • Quality by Design (QbD) Principles in Scale-Up

• 2. Regulatory Requirements and Guidance for Scale-Up

  • FDA Regulations (e.g., cGMP, ICH Guidelines)

  • ANDA and NDA Submissions

  • Post-Approval Changes and Supplements

  • Global Harmonization Efforts

• 3. Process Analytical Technology (PAT) in Scale-Up

  • Fundamentals of PAT

  • Applications of PAT in Process Monitoring and Control

  • Implementing PAT in a Scale-Up Environment

  • Benefits of PAT for Quality Control

• 4. Solid Dosage Forms: Unit Operations and Scale-Up Considerations

  • A. Blending and Mixing

    • Principles and Equipment

    • Scale-Up Challenges

    • Process Parameters and Control

  • B. Granulation (Wet and Dry)

    • Granulation Technologies

    • Effect of Scale on Granule Properties

    • Troubleshooting and Optimization

  • C. Drying

    • Drying Mechanisms and Equipment

    • Scale-Up of Drying Processes

    • Impact on Product Quality

  • D. Compression and Tableting

    • Tablet Presses and Tooling

    • Tablet Properties and Defects

    • Scale-Up of Compression

  • E. Coating

    • Coating Technologies

    • Process Optimization for Scale-Up

    • Quality Control of Coated Products

• 5. Liquid and Semisolid Dosage Forms: Scale-Up Challenges

  • A. Solutions and Suspensions

    • Mixing and Dissolution

    • Suspension Stability and Homogeneity

    • Filtration and Sterilization Scale-Up

  • B. Emulsions and Gels

    • Emulsification Methods

    • Stability Issues

    • Scale-Up of High-Shear Mixing Processes

  • C. Ointments and Creams

    • Manufacturing Processes

    • Rheological Considerations

    • Impact of Scale on Product Texture

• 6. Sterile Products: Aseptic Processing and Lyophilization Scale-Up

  • A. Aseptic Processing

    • Facility Design and Environmental Control

    • Sterilization Methods

    • Process Validation in Scale-Up

  • B. Lyophilization (Freeze-Drying)

    • Principles of Freeze-Drying

    • Cycle Development and Optimization for Scale-Up

    • Equipment Considerations

• 7. Biological Products: Unique Scale-Up Challenges

  • Cell Culture and Fermentation Scale-Up

  • Downstream Processing and Purification

  • Analytical Challenges for Biologics

  • Regulatory Aspects for Biopharmaceutical Scale-Up

• 8. Process Validation and Technology Transfer

  • Goals of Process Validation

  • Stages of Validation (Process Design, Process Qualification, Continued Process Verification)

  • Technology Transfer Best Practices

  • Documentation and Change Control

• 9. Risk Management in Pharmaceutical Scale-Up

  • Identifying and Assessing Risks

  • Risk Mitigation Strategies

  • Failure Mode and Effects Analysis (FMEA)

  • Continuous Improvement

• 10. Quality Control from Manufacturer to Customer

  • In-Process Controls

  • Finished Product Testing

  • Stability Studies

  • Supply Chain Quality Management

  • Customer Feedback and Complaints

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