How To Validate A Pharmaceutical Process: Part Of The Expertise In Pharmaceutical Process…

Paperback | June 7, 2016

bySteven Ostrove

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How to Validate a Pharmaceutical Process provides a how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

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How to Validate a Pharmaceutical Process provides a how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses pra...

Dr. Ostrove has over 30 years of experience in validation compliance, quality assurance, and regulatory affairs. In addition, he has developmental and process expertise in mammalian cell culture and separation technology. His general pharmaceutical experience includes sterile techniques (Aseptic processing), Process Validation, Cleanin...
Format:PaperbackDimensions:218 pages, 8.75 × 6.35 × 0.68 inPublished:June 7, 2016Publisher:Academic PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:012804148X

ISBN - 13:9780128041482

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Table of Contents

Preface

  1. Introduction
  2. New & Legacy Products

    The three phases of PV

    What it will attempt to do

    Product Status

    Section I What is Process Validation and Why do Process Validation?

  3. Defining Process Validation
    1. Risk Based Approach
    2. Good Science

  4. Brief Review of the Regulations and Guidelines
    1. 21CFR
    2. ICH
    3. Other regulatory information

  5. The Role of Change Control
  6. Section II Stage I Process Development

  7. Starting the Process Validation Program
    1. Validation Master Plan
    2. SOPs
    3. Quality Programs

  8. Equipment and Utility Qualification
    1. Determining what needs to be done
      1. Direct
      2. Indirect
      3. System Boundaries

    2. Commissioning
    3. Qualification
      1. IQ
      2. OQ
      3. PQ

  9. Dealing with Computers and Automation Validation
    1. General Computer System Validation
    2. Part 11

  10. Process Development
    1. Risk Assessment
    2. Process Description (Defining the process)
    3. Critical v. Non-Critical
    4. Determining CPPs and CQAs
    5. What variables are in the process
      1. Why are they variable?
      2. Can they be controlled?

    Section II Process Qualification

  11. The Process Validation Protocol
    1. What makes a good protocol
    2. Sampling Plans for Process Validation
    3. Conducting the Process Validation protocol
      1. Solid Dose
      2. Creams, Liquids and Ointments
      3. Parenterals

    4. Preparing theProcess Validation report

  12. Dealing with Deviations
    1. Investigations
    2. Resolution

    Section III Continued Process Verification

  13. Collecting and Evaluating Production
    1. Use of Control Charts

  14. Use of Statistical Process Control pPk, Pk, cPk, cP
  15. Section IV Other Related Activities

  16. Cleaning- Verification to Validation
  17. Facility Qualification