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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5495_Библиотеки_им_академика_М_И_Перельмана
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Basics of Pharmaceutical
Manufacturing and
Quality Operations
This book provides guidance on how to meet the requirements of the pharmaceutical
industry as a beginner. It includes procedures for production and packaging, batch
auditing as well as all quality measures used in the pharmaceutical industry. This
book also provides questions and answers with each chapter for institutes and train‑
ers providing basic training to the new graduates and newcomers to the industry.
Basics of Pharmaceutical Manufacturing and Quality Operations: A
Comprehensive Guide is primarily written for anyone in the pharmaceutical indus‑
try interested in development and manufacturing of active pharmaceutical ingredi‑
ent (API) and nished pharmaceutical manufacturers in both sterile and non‑sterile
areas. The book is a simple, concise, and easy to use reference tool covering basic
quality concepts required by the pharmaceutical educational institutions and profes‑
sional certication bodies. It describes details of all GXP activities that are directly
related to quality, safety, and efcacy of the products manufactured under the
umbrella of Quality Operations, common testing methods which are used in any
modern industry, Requirements of Validation and Qualication of equipment, facili‑
ties and processes, integral segments of Drug product manufacturing, storage, and
distribution practices. The material provides stepwise guidance on how to evaluate,
audit, qualify, and approve a pharmaceutical product to enhance the GMP within the
industry.
The book is written with the idea of providing basic knowledge to undergraduate
students who are preparing to enter the industry at the end of their graduation. The
book would also be benecial for institutions conducting pharmaceutical technology
study courses in terms of GMP and GLP applications.
Features:
1. Provides readers and frontline healthcare product manufacturers, all the
information they need to know to develop a GMP oriented industry with
trained and skilled personnel and manufacture products that meet GMP and
regulatory requirements.
2. Provides stepwise guidance on how to evaluate, audit, qualify, and approve a
pharmaceutical product and packaging material to enhance the GMP within
the industry.
3. Includes signicant processes and steps in production for all common dos‑
age forms.
4. Explains how in‑process and nished products are released.
5. Provides an ideal and effective tool for anyone starting quality assurance/
quality control/production responsibilities.
Basics of Pharmaceutical
Manufacturing and
Quality Operations
A Comprehensive Guide
Erfan Syed Asif, Ph.D
and Shahid Bader Usmani, Ph.D
Designed cover image: © Shutterstock and istockphoto
First edition published 2024
by CRC Press
2385 NW Executive Center Drive, Suite 320, Boca Raton FL 33431
and by CRC Press
4 Park Square, Milton Park, Abingdon, Oxon, OX14 4RN
CRC Press is an imprint of Taylor & Francis Group, LLC
© 2024 Erfan Syed Asif and Shahid Bader Usmani
Reasonable eorts have been made to publish reliable data and information, but the author and
publisher cannot assume responsibility for the validity of all materials or the consequences of
their use. e authors and publishers have attempted to trace the copyright holders of all material
reproduced in this publication and apologize to copyright holders if permission to publish in this
form has not been obtained. If any copyright material has not been acknowledged, please write and
let us know so we may rectify in any future reprint.
Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced,
transmitted, or utilized in any form by any electronic, mechanical, or other means, now known
or hereafter invented, including photocopying, microlming, and recording, or in any information
storage or retrieval system, without written permission from the publishers.
For permission to photocopy or use material electronically from this work, access www.copyright.
com or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, M A
01923, 978‑750‑84 00. For works th at are not avail able on CCC please contac t mpkbooksperm issions@
tandf.co.uk
Trademark notice: Product or corporate names may be trademarks or registered trademarks and are
used only for identication and explanation without intent to infringe.
ISBN: 9781032432052 (hbk)
ISBN: 9781032432465 (pbk)
ISBN: 9781003366393 (ebk)
DOI: 10.1201/9781003366393
Typeset in Times
by codeMantra
https://t.me/med1917
To the authors’ Alma‑Mater, Hussain Ebrahim Jamal Research
Institute of Chemistry, University of Karachi, which served
the pharmaceutical industry not just in Pakistan but all over the
world by producing scientists, inventors and innovative thinkers in
Research & Development, manufacturing, and quality operations.
https://t.me/med1917
vii
Contents
About the Authors .....................................................................................................ix
Preface.......................................................................................................................xi
Chapter 1
Good Manufacturing Practice (GMP), Good Lab
Practice (GLP) and Good Documentation Practice (GDP) .................. 1
Chapter 2 Concept of Calibration ....................................................................... 15
Chapter 3 Reference Standards and Reagents ....................................................24
Chapter 4 Chemical Tests ...................................................................................32
Chapter 5 Physical Testing of Raw Materials, Intermediate,
and Finished Products ........................................................................ 49
Chapter 6 Data Integrity ..................................................................................... 63
Chapter 7 Process Validation .............................................................................. 68
Chapter 7.1 Protocol Generation ........................................................................... 73
Chapter 7. 2 Sampling and Testing Plan ................................................................. 87
Chapter 7. 3 Process Validation Report Writing ....................................................93
Chapter 8 Cleaning Validation .......................................................................... 117
Chapter 9 Method Development and Method Validation ................................. 126
Chapter 10
Qualication and Its Segments ........................................................134
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viii Contents
Chapter 10.1 User Requirement Specication .....................................................160
Chapter 10.2 Functional Specication .................................................................175
Chapter 11 Stability Studies, Stability Indicating,
and Methods Degradates ................................................................182
Chapter 12 Technology Transfer .......................................................................189
Chapter 13 Dispensing.......................................................................................193
Chapter 14 Production .......................................................................................198
Chapter 15 Packaging ....................................................................................... 209
Chapter 16 Role of Quality Assurance .............................................................. 214
Chapter 17 Role of Quality Control ..................................................................218
Chapter 18 Logistics–Cold Chain Supply ...................................................... 226
Chapter 19
GMP for Biologics and Similar Medicines .................................... 230
Chapter 20 QA/QC Release .............................................................................. 236
Index ....................................................................................................................... 251
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ix
About the Authors
Erfan Syed Asif earned his PhD in organic chemistry
and has expertise in various areas of quality operations
with over 28 years of experience in pharmaceutical
industries in Pakistan, UAE, Kingdom of Saudi
Arabia, United States, and Canada. He has worked
in U.S. FDA- and Health Canada-approved facilities
in various Leading roles. He has extensive experience
in overseeing qualication projects for manufacturing
equipment, utilities, systems, sterilization techniques,
aseptic processes simulation, API site audits and sterile
and non-sterile products manufacturing processes,
and decommissioning of equipment.
Dr.Asif currently holds the position of senior quality consultant with PharmEng
Technology Inc, Toronto, Canada and is overseeing various Quality related projects
at Sano-Pasteur, Toronto, Canada.
Dr.Asif is the author of many research publications in internationally published
chemistry journals and conference proceedings. He has authored and co-authored
four books all published by Taylor & Francis/CRC Press.
Dr.Asif also participates as a guest speaker at Windsor University, Ontario, Canada
to deliver lectures on GMP to the graduate students of Masters in Medical Technology,
International Center of Chemical and Biological Sciences (ICCBS), Karachi Pakistan
and Association of Pakistani Physicians in North America (APPNA).
Dr.Asif is a certied ASQ Quality Auditor and a member of American Society
for Quality as well as a member of Royal Society of Chemistry, UK.
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x About the Authors
Usmani Shahid Bader obtained his Ph.D. in organic
chemistry and has expertise in various areas of
quality operations with over 25 years of experience
in pharma ceutical industries in Pakistan and Canada.
He has worked in a leading role in U.S. FDA- and
Health Canada-approved facilities. He has extensive
experience in overseeing quality projects.
He has 33 publications in leading international
jour nals. Due to his extensive research contribution,
he was selected to conduct one year of research at the
Tokyo Institute of Chemistry, Japan, among 1 of 14
scientists selected from all over the world.
Dr. Usmani currently holds the position of
Group Leader with Viatris Pharmaceutical Canada,
Toront o.
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