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AAPS Introductions in the Pharmaceutical Sciences

Solid Oral Dose Process Validation

The Basics, Volume 1

Authors: Pazhayattil, A., Sayeed-Desta, N., Fredo-Kumbaradzi, E., Collins, J.

  • First publication to address process validation and the lifecycle process
  • ​Essential information for pharmaceutical professional who use process lifecycle validation
  • Addresses the need for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance
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Buy this book

eBook $79.99
price for USA in USD (gross)
  • ISBN 978-3-030-02472-7
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $99.99
price for USA in USD
  • ISBN 978-3-030-02471-0
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
About this book

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.

About the authors

Prior to Eurofins, Mr. Pazhayattil held leadership roles with brand name, generic and contract manufacturing organizations. He is an Industrial Pharmacist successful in conceiving, implementing, promoting novel technologies and innovations based on sound scientific principles. His experience extends through solid dose, liquids, small and large volume parenteral dosage forms. Ajay has successfully delivered tangible results in multiple segments of pharmaceutical operations. He has lead successful transfer of Rx and OTC products, managed process development and validation activities for solid dose, liquids and parenteral products. Ajay has lead selection, installation and qualification of equipment's including powder injection lines. He has conducted extensive GMP audits of raw material, formulation, medical device and clinical sites. 

 

He has: developed Process Validation Master Plan based on ICH Lifecycle concept; conceived, developed and implemented a comprehensive PV Lifecycle Management System; established PV Community of Practice to share knowledge; Introduced methodologies for the industry: Pa, # of batch determination, Stage 3A- PCQd, IPV, PaCS Index. He has received multiple Global Recognition Awards. His recent AAPS PharmSciTech journal publications include: 1) Assessment Methodology for Process Validation Lifecycle Stage 3A; 2) A Scientific Approach to Determine number of PPQ batches and 3) Acceptance Probability (Pa) for Process Validation Lifecycle Stages.

 

Ms. Naheed Sayeed-Desta has more than 17 years of pharmaceutical industry experience and was leading Technical Operations, Process Validation teams at Apotex Inc., prior to leading Sanofi Process Validation team. Naheed was responsible for providing strategic directions on Process Validation Stage 1, 2 and 3 life-cycle management of over 300 molecules. As a global cross site leader, Naheed championed delivery of science and risk based approaches for solid dose products from traditional to novel manufacturing technologies and approaches across the organization. She was the lead author of AAPS PharmSciTech journal article Assessment Methodology for Process Validation Lifecycle Stage 3A. She is a contributing member of PDA Post Approval Change Innovation for Availability of Medicines Program and is involved in developing PDA Technical Report on ICH Q12 tools.

 

Dr. 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.

 

Dr. 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.


Table of contents (7 chapters)

  • Life Cycle Approach to Process Validation

    Pazhayattil, Ajay Babu (et al.)

    Pages 1-7

  • Solid Dose Formulations

    Pazhayattil, Ajay Babu (et al.)

    Pages 9-28

  • Stage 1A Process Design: Quality by Design

    Pazhayattil, Ajay Babu (et al.)

    Pages 29-35

  • Knowledge Management and Risk Assessment for Life Cycle Stages

    Pazhayattil, Ajay Babu (et al.)

    Pages 37-51

  • Stage 1B Process Scale-Up Considerations

    Pazhayattil, Ajay Babu (et al.)

    Pages 53-59

Buy this book

eBook $79.99
price for USA in USD (gross)
  • ISBN 978-3-030-02472-7
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $99.99
price for USA in USD
  • ISBN 978-3-030-02471-0
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
Solid Oral Dose Process Validation
Book Subtitle
The Basics, Volume 1
Authors
Series Title
AAPS Introductions in the Pharmaceutical Sciences
Copyright
2018
Publisher
Springer International Publishing
Copyright Holder
American Association of Pharmaceutical Scientists
eBook ISBN
978-3-030-02472-7
DOI
10.1007/978-3-030-02472-7
Hardcover ISBN
978-3-030-02471-0
Series ISSN
2522-834X
Edition Number
1
Number of Pages
XIV, 92
Number of Illustrations
17 b/w illustrations, 37 illustrations in colour
Topics