© 2019

Solid Oral Dose Process Validation, Volume Two

Lifecycle Approach Application


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

Table of contents

  1. Front Matter
    Pages i-xii
  2. Ajay Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Marzena Ingram, Jordan Collins
    Pages 1-36
  3. Ajay Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Marzena Ingram, Jordan Collins
    Pages 37-55
  4. Ajay Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Marzena Ingram, Jordan Collins
    Pages 57-74
  5. Ajay Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Marzena Ingram, Jordan Collins
    Pages 75-85
  6. Ajay Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Marzena Ingram, Jordan Collins
    Pages 87-105
  7. Back Matter
    Pages 107-108

About this book


The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation.


QbD product development Scale up tech transfer Batch sampling Batch testing Batch determination CPV Continuous Process Verification CPV monitoring

Authors and affiliations

  1. 1.Independent Management ConsultantWellandCanada
  2. 2.Sanofi PasteurTorontoCanada
  3. 3.Apotex Inc.TorontoCanada
  4. 4.Eurofins AlphoraRichmond HillCanada
  5. 5.Privacy AnalyticsAn IQVIA CompanyTorontoCanada

About the authors

Ajay Pazhayattil is an Industrial Pharmacist successful in conceiving, implementing and promoting novel methodologies in Pharmaceutical Quality Assurance, Regulatory Affairs, Technical Operations and Manufacturing Operations based on sound scientific principles. His industry experience extends through solid dose, liquids and parenteral dosage forms. Ajay has been in leadership roles with Eurofins, Apotex, Pharmetics, ANI Pharmaceuticals, Vita Health, Patheon, Emcure and Accord Pharma. He has implemented a comprehensive Life-cycle Management System supporting ICH Q8 to Q12 for global sites. He holds an M. Pharm in Medicinal Chemistry and completed his Doctoral program in business. He has authored multiple Pharmaceutical journal articles.

 Naheed Sayeed-Desta has extensive experience in formulation, technology transfer and validation providing strategic directions on life-cycle management of small molecules.  She is the lead author of several journal articles and is an active contributor in industry organizations. Naheed earned her BSc. Degree in Biology from Western University and MBA in Management from California Southern University. She currently holds the position of Deputy Director of Validation Services at Sanofi Pasteur in Toronto, Ontario providing leadership in the biopharmaceutical quality sector.

 Emilija Fredro-Kumbaradzi is Manager of Biowaivers & Biocorrelation team within the Formulation Development Department at Apotex Inc, Toronto responsible for Biopharmaceutical aspects of drug product. She has extensive experience in formulation development of generic formulations for immediate and modified release products intended for various markets. Prior to Apotex, she has held a position of Professor of Pharmaceutical Technology at Faculty of Pharmacy at University of Skopje, Macedonia. She has received her B.Sc. degree in Pharmacy from the University of Skopje, MSc. Degree from the University of Belgrade, Serbia and Ph D. degree in Pharmaceutical Sciences from the University of Skopje, Macedonia. Her current research interests include solid dosage forms of low soluble drugs and various approaches and technologies in drug formulation to remediate solubility and stability issues, Selection of bio indicative dissolution and in silico modelling.

 Marzena Ingram is a pharmaceutical industry professional with extensive quality assurance and technical operations experience in solid dose and active pharmaceutical ingredients manufacturing operations. She holds senior management position at Eurofins Alphora Research Inc. Prior to Eurofins, Marzena was Senior Manager, Continued Process Verification at Apotex Inc. Ingram developed a specialized Continued Process Verification team and spearheaded the implementation of a product lifecycle program to meet the global regulatory requirements. She has also introduced and published statistically driven product assessment processes. Ms. Ingram has lead implementation of a comprehensive Process Validation life cycle management software solution.

 Jordan Collins is Senior Solutions Architect at Privacy Analytics, an IQVIA Company, responsible for leading client engagements assessing the risk of re-identification of individuals and supplying guidance on anonymization for data sets shared for secondary purposes. He also currently provides statistical consulting services, primarily to healthcare researchers and pharmaceutical companies. He has extensive experience in performing statistical analyses across a wide variety of industries. Prior to Privacy Analytics, he held the position of Manager, Statistical Support at Apotex Inc. He received his B. Sc. (Honours) degree in Mathematics from Mount Allison University, MSc. degree in Mathematics from McMaster University, M.A. degree in Applied Statistics from York University, and PhD. degree in Philosophy from the University of Auckland, New Zealand. His current research interests include the application of Bayesian statistics to industrial decision making and the development of machine learning techniques for use in process optimization.

Bibliographic information

  • Book Title Solid Oral Dose Process Validation, Volume Two
  • Book Subtitle Lifecycle Approach Application
  • Authors Ajay Pazhayattil
    Naheed Sayeed-Desta
    Emilija Fredro-Kumbaradzi
    Marzena Ingram
    Jordan Collins
  • Series Title AAPS Introductions in the Pharmaceutical Sciences
  • Series Abbreviated Title AAPS Introductions in the Pharmaceutical Sciences
  • DOI
  • Copyright Information American Association of Pharmaceutical Scientists 2019
  • Publisher Name Springer, Cham
  • eBook Packages Biomedical and Life Sciences Biomedical and Life Sciences (R0)
  • Hardcover ISBN 978-3-030-27483-2
  • eBook ISBN 978-3-030-27484-9
  • Series ISSN 2522-834X
  • Series E-ISSN 2522-8358
  • Edition Number 1
  • Number of Pages XII, 108
  • Number of Illustrations 23 b/w illustrations, 60 illustrations in colour
  • Additional Information sold separately and as a set
  • Topics Pharmacology/Toxicology
  • Buy this book on publisher's site