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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5335_Библиотеки_им_академика_М_И_Перельмана.pdf
Published by
World Scientic Publishing Co. Pte. Ltd.
5 Toh Tuck Link, Singapore 596224
USA oce: 27 Warren Street, Suite 401-402, Hackensack, NJ 07601
UK oce: 57 Shelton Street, Covent Garden, London WC2H 9HE
Library of Congress Cataloging-in-Publication Data
Names: Chan, Lai Wah, author. | Sia, Chong Hock, author.
Title: Manufacture and supply, science and regulation towards high-quality medicinal products /
Lai Wah Chan, Chong Hock Sia.
Description: New Jersey : World Scientic, [2025] | Includes bibliographical references and index.
Identiers: LCCN 2024025058 | ISBN 9789811295492 (hardcover) |
ISBN 9789811295508 (ebook for institutions) | ISBN 9789811295515 (ebook for individuals)
Subjects: LCSH: Pharmaceutical technology--Standards. | Pharmaceutical industry--Standards.
Classication: LCC RS192 .C52155 2025 | DDC 338.4/76151--dc23/eng/20240820
LC record available at https://lccn.loc.gov/2024025058
British Library Cataloguing-in-Publication Data
A catalogue record for this book is available from the British Library.
Copyright © 2025 by World Scientic Publishing Co. Pte. Ltd.
For photocopying of material in this volume, please pay a copying fee through the Copyright Clearance
Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, USA. In this case permission to photocopy
is not required from the publisher.
For any available supplementary material, please visit
https://www.worldscientic.com/worldscibooks/10.1142/13909#t=suppl
Desk Editor: Shaun Tan Yi Jie
Typeset by Stallion Press
Email: enquiries@stallionpress.com
Printed in Singapore
About the Authors
v
Dr Chan Lai Wah is an Associate Professor in
Pharmaceutics at the Department of Pharmacy
and Pharmaceutical Sciences of the National
University of Singapore (NUS), where she has
lectured for more than 30 years and won many
awards for excellence in teaching. In particular,
she has been placed on the NUS Faculty Honor
Roll for a record three times in 2005, 2009 and
2015 for continuous teaching excellence. She is also the co-founder
of GEA-NUS Pharmaceutical Processing Research Laboratory,
which serves as an international platform for promoting research
and manpower training in process technology. Her research interests include pharmaceutical formulation and processing, pharmaceutical microbiology, and the quality and safety issues of medicinal
products. To date, she has supervised and successfully graduated 34 PhD and 9 MSc students by research. In addition, she has
vi
Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
co-authored about
180 scientific papers
in peer-reviewed
journals besides
numerous conference papers. She
has also served as a
technical expert for
the Singapore Ac cre ditation Council,
scientific reviewer
for local and overseas research grants,
thesis examiner for local and overseas universities as well as reviewer
for international scientific journals.
In addition to her research and teaching excellence, Professor Chan
has devoted much of her time to service and leadership. She was SubDean of the Faculty of Science from July 2000 to April 2002. Since
2000, she has served in many programs and committees, including
Chair of the Science Research Program, NUS Science Mentorship
Program and Faculty Alumni Day Committee. For many years, she
had been the Chair of NUS Pharmacy Graduate Program Committee, Chair of the Pharmacy Department Teaching Excellence Committee, Member of Faculty of Science Teaching Excellence Committee, as well as Member of the Selection Panel for NUS Scholarships.
She was also Chair of the Organizing Committee for the 14th International Microencapsulation Symposium, as well as organizing
committee member for numerous regional and international pharmaceutical technology conferences and workshops. More recently
from 2021 to 2023, she was appointed to the NUS Senate Delegacy.
About the Authors
Mr Sia Chong Hock has been the Director of
Quality Assurance and Senior Consultant of
Audit and Licensing at the Singapore Health
Sciences Authority (HSA) since 2015 to date,
where he was previously the Director of the
Audit and Licensing Division in the period
2008–2015. From 1995 to 2022, he was also an
Adjunct Associate Professor at the Department
of Pharmacy and Pharmaceutical Sciences of the National University of Singapore (NUS). He had been a member of the Singapore
Pharmacy Council and its predecessor Singapore Pharmacy Board
from 2002 to 2018, including being the Chair of its Complaints
Panel. He holds a Bachelor’s degree in Pharmacy from NUS, as well
as a Master’s degree in Healthcare Management (with Distinction)
from the University of Wales, UK.
vii
Mr Sia has played a monumental role in, and won many awards for,
shaping Singapore to be a world leader in pharmaceutical regulation.
He took up the challenge to set up the GMP Audit Unit and led Singapore to become the first Asian member of the international Phar maceutical Inspection Co-operation
Scheme (PIC/S) in
2000, and was subsequently appointed
Chair of the ASEAN
MRA Task Force
and Joint Sectoral
Committee on
GMP Inspection
from 2005 to 2020.
viii
Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
In 2013, he was conferred
the Industry Pharmacist
of the Year Award by the
Pharmaceutical Society
of Singapore, and in 2016,
he was honored with the
International Pharmaceutical Society of Pharmaceutical Engineering (ISPE) Singapore Aliate Lifetime
Achievement Award for his
contributions to the field of
Pharmaceutical Regulatory Practices in Singapore and the ASEAN
region. More recently, he was a recipient of the PS(Health) Award
2023 for his key role as a core team member responsible for HSA
being the first National Regulatory Authority (NRA) in the world
to achieve Maturity Level 4 under the World Health Organization
Global Benchmarking Tools (WHO GBT) assessment. This WHO
GBT certification confirms HSA as an NRA that is operating at an
advanced level of regulation in medicinal products and vaccines. On
the academic front, he contributes review articles to international
scientific journals, covering the regulation of pharmaceuticals and
biopharmaceuticals. In 2016 and 2019, two of his articles won the
ISPE Roger Sherwood Article of the Year Award.
Preface
ix
The COVID-19 pandemic, ocially declared by the World Health
Organization (WHO) in March 2020, was a black swan event. The
rapid spread of COVID-19 across international borders and its
impact on the world were unexpected and unprecedented. A record
number of people lost their lives, and there were numerous sad, sorrowful and heartbreaking stories. All domestic and international
business activities grounded to a halt, and most people stayed at
home or worked remotely. At the height of the pandemic, there
was a global surge of interest in COVID-19 vaccines, anti-viral and
anti-bacterial drugs, hand sanitizers, disinfectants, face masks and
other medicinal and healthcare products. When it became apparent that the COV ID-19 pandemic was going to be protracted, we
(the authors) began looking for silver linings amidst the dark clouds
of the pandemic. We began to look for educational materials on
vaccines, pharmaceuticals and biopharmaceuticals, and discovered
that we collectively possess a “treasure trove” of these materials.
x
Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Our prized possessions range from our lecture notes to undergraduate and graduate students, to published scientific papers and conference presentations on these topics, as well as our own personal
experiences. At that juncture, we decided that these sets of knowledge and materials should be systematically assembled into a book
and be shared with all interested parties. Thus, it can be said that
the seeds for this work were sown sometime during the peak of the
COV ID-19 pandemic.
In this book, readers will get to understand quality and safety issues
relating to a broad spectrum of medicinal products, which are also
referred to as medical products, medicines, drug products, therapeutic products or generally as healthcare products by dierent
national jurisdictions, regional and international organizations.
Depending on the discussion topic, these terms may be used interchangeably to align with the terminology most commonly used
in the countries or geographical regions concerned. The products
covered herein range from traditional and herbal medicinal products, health supplements, to pharmaceuticals and biopharmaceuticals, including recombinant proteins, monoclonal antibodies, novel
and traditional vaccines, as well as cells, tissues and gene therapy
products. The upstream manufacture and assurance of quality and
supply chain integrity for active pharmaceutical ingredients and
excipients, narcotic drugs and psychotropic substances, have been
given their due attention too. Quality and safety issues arising from
product contamination and adulteration, as well as falsified and
counterfeit medicines have also been highlighted, together with
their trends and proposed solutions to combat these sub-standard
and spurious medicines. Concurrently, the book examines the risks
and opportunities, as well as the challenges and benefits, faced by
pharmaceutical manufacturers, regulatory authorities and the