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Solid Oral Dose Process Validation

The Basics, Volume 1

  • Ajay Babu Pazhayattil
  • Naheed Sayeed-Desta
  • Emilija Fredro-Kumbaradzi
  • Jordan Collins

Part of the AAPS Introductions in the Pharmaceutical Sciences book series (AAPSINSTR)

Table of contents

  1. Front Matter
    Pages i-xiv
  2. Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins
    Pages 1-7
  3. Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins
    Pages 9-28
  4. Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins
    Pages 29-35
  5. Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins
    Pages 37-51
  6. Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins
    Pages 53-59
  7. Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins
    Pages 61-78
  8. Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins
    Pages 79-89
  9. Back Matter
    Pages 91-92

About this book

Introduction

Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.

Keywords

solid dose manufacturing QbD pharma Stage 2A and 2B PPQ CPV requirements ICH Risk Assessment Pharma manufacturing risk assessment OSD manufacturing

Authors and affiliations

  • Ajay Babu Pazhayattil
    • 1
  • Naheed Sayeed-Desta
    • 2
  • Emilija Fredro-Kumbaradzi
    • 3
  • Jordan Collins
    • 4
  1. 1. Eurofins Alphora Reserach Inc. (Canada)TorontoCanada
  2. 2.Apotex (Canada)TorontoCanada
  3. 3.Apotex (Canada)TorontoCanada
  4. 4.IQVIA (Canada)TorontoCanada

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-030-02472-7
  • Copyright Information American Association of Pharmaceutical Scientists 2018
  • Publisher Name Springer, Cham
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-3-030-02471-0
  • Online ISBN 978-3-030-02472-7
  • Series Print ISSN 2522-834X
  • Series Online ISSN 2522-8358
  • Buy this book on publisher's site