How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process

by Steven Ostrove PhD

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Product Details

ISBN-13: 9780128041482
Publisher: Elsevier Science
Publication date: 06/21/2016
Edition description: New Edition
Pages: 218
Sales rank: 938,746
Product dimensions: 5.90(w) x 8.90(h) x 0.50(d)

About the Author

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, Cleaning and Sterilization Validation, Packaging Systems, Process Development and Process Scale-up. He also has industry experience with the development and validation of PC and PLC-based computer control systems for the biotech and pharmaceutical markets, guidance on system optimization for CIP/SIP and has led teams for the review of all GMP documents starting with their preparation (e.g., protocols, SOPs, and validation master plans). Dr. Ostrove has worked on several consent degree remediation and audit teams and his experience covers both EU and US regulations.

Table of Contents


  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

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