, A Text Book Of
PHARMACEUTICAL
QUALITY ASSURANCE
As Per PCI Regulations
THIRD YEAR B. PHARM.
Semester VI
Anusuya R. Kashi Bindu Sukumaran
Assistant Professor, Assistant Professor,
Vivekananda College of Pharmacy, Vivekananda College of Pharmacy,
nd nd
Dr. Raj Kumar Road, Rajajinagar 2 Stage, Dr. Raj Kumar Road, Rajajinagar 2 Stage,
Bengaluru – 560 055, Karnataka, India Bengaluru – 560 055, Karnataka, India
Venna P.
Assistant Profesor and Vice Principal,
Vivekananda College of Pharmacy,
nd
Dr. Raj Kumar Road, Rajajinagar 2 Stage,
Bengaluru – 560 055, Karnataka, India
Price ` 150.00
N4088
,Pharmaceutical Quality Assurance ISBN 978-93-89825-24-4
First Edition : January 2020
© : Authors
The text of this publication, or any part thereof, should not be reproduced or transmitted in any form or stored in any computer
storage system or device for distribution including photocopy, recording, taping or information retrieval system or reproduced on any disc,
tape, perforated media or other information storage device etc., without the written permission of Authors with whom the rights are
reserved. Breach of this condition is liable for legal action.
Every effort has been made to avoid errors or omissions in this publication. In spite of this, errors may have crept in. Any mistake, error
or discrepancy so noted and shall be brought to our notice shall be taken care of in the next edition. It is notified that neither the publisher
nor the authors or seller shall be responsible for any damage or loss of action to any one, of any kind, in any manner, therefrom.
Published By : Polyplate Printed By :
NIRALI PRAKASHAN YOGIRAJ PRINTERS AND BINDERS
Abhyudaya Pragati, 1312, Shivaji Nagar, Works: Sr. No. 10\1,Ghule Industrial Estate,
Off J.M. Road, PUNE – 411005 Nanded Village Road,
Tel - (020) 25512336/37/39, Fax - (020) 25511379 TAL-HAVELI, DIT-PUNE 411041.
Email : Mobile - 9850046517, 9404225254
DISTRIBUTION CENTRES
PUNE
Nirali Prakashan : 119, Budhwar Peth, Jogeshwari Mandir Lane, Pune 411002, Maharashtra
(For orders within Pune) Tel : (020) 2445 2044, Fax : (020) 2445 1538; Mobile : 9657703145
Email :
Nirali Prakashan : S. No. 28/27, Dhayari, Near Asian College Pune 411041
(For orders outside Pune) Tel : (020) 24690204 Fax : (020) 24690316; Mobile : 9657703143
Email :
MUMBAI
Nirali Prakashan : 385, S.V.P. Road, Rasdhara Co-op. Hsg. Society Ltd.,
Girgaum, Mumbai 400004, Maharashtra; Mobile : 9320129587
Tel : (022) 2385 9976, Fax : (022) 2386 9976
Email :
DISTRIBUTION BRANCHES
JALGAON
Nirali Prakashan : 34, V. V. Golani Market, Navi Peth, Jalgaon 425001, Maharashtra,
Tel : (0257) 222 0395, Mob : 94234 91860; Email :
KOLHAPUR
Nirali Prakashan : New Mahadvar Road, Kedar Plaza, 1st Floor Opp. IDBI Bank, Kolhapur 416 012
Maharashtra. Mob : 9850046155; Email :
NAGPUR
Nirali Prakashan : Above Maratha Mandir, Shop No. 3, First Floor,
Rani Jhanshi Square, Sitabuldi, Nagpur 440012, Maharashtra
Tel : (0712) 254 7129; Email :
DELHI
Nirali Prakashan : 4593/15, Basement, Agarwal Lane, Ansari Road, Daryaganj
Near Times of India Building, New Delhi 110002 Mob : 08505972553
Email :
BENGALURU
Nirali Prakashan : Maitri Ground Floor, Jaya Apartments, No. 99, 6th Cross, 6th Main,
Malleswaram, Bengaluru 560003, Karnataka; Mob : 9449043034
Email:
Other Branches : Hyderabad, Chennai
Note: Every possible effort has been made to avoid errors or omissions in this book. In spite this, errors may have crept in. Any type of error
or mistake so noted, and shall be brought to our notice, shall be taken care of in the next edition. It is notified that neither the publisher, nor
the author or book seller shall be responsible for any damage or loss of action to any one of any kind, in any manner, therefrom. The reader
must cross check all the facts and contents with original Government notification or publications.
| www.pragationline.com
Also find us on www.facebook.com/niralibooks
, Preface
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
While quality is the single-most important requirement for any product, it becomes even more
critical in the pharmaceutical industry where patients rely on medicines to cure, prevent and mitigate
diseases. From the times when mere quality control testing was sufficient to approve products as fit for
use, we have now progressed to the realization that quality must be built into drug products from the
very initial design phase. Quality assurance (QA) comprises the sum total of all that goes into ensuring
that products manufactured are of the intended quality that makes them fit for use. Understanding
the several different aspects of QA is therefore a vital first step in working towards attaining desired
quality products.
It gives us great pleasure to present this Textbook of Pharmaceutical Quality Assurance to the
students of the B. Pharm. course. It has been our endeavour to make the content student-friendly and
towards this end, we have included objectives at the beginning and review questions at the end of
each chapter. While we have tried to verify all details provided in this book, it is quite possible that
some information may need greater clarity or amendment – if you, the readers, notice any errors or
scope for improvement, we will be most obliged to receive your feedback and suggestions.
For teachers, explaining concepts in a classroom is very easy; writing the same content in a lucid
style that holds students’ attention is definitely more challenging. We thank our family and friends for
their encouragement in achieving this milestone. We express special thanks to Mr. R. E. Narayana, our
senior librarian in the Vivekananda College of Pharmacy who put us in touch with Mr. Ramakrishna of
Nirali Prakashan and sowed the initial idea of writing this textbook. Their encouragement has been
instrumental in guiding our efforts. It has also been a pleasure to work with Ms. Roshan Khan,
Co-ordinator of Pharmacy Department of Nirali Prakashan.
We are grateful to the management of the Janatha Education Society for their support to this
venture. We are deeply grateful to our college Principal, Dr. D. Narasimha Reddy, for his constant
support and guidance.
We also take this opportunity to thank Ms. Vasundhara Rama Iyengar for her help in structuring
the content of this textbook. With close to 30 years of service in the pharmaceutical industry, having
served as the Quality Head in reputed pharmaceutical companies such as AstraZeneca Pharma India
Limited and GlaxoSmithKline Pharmaceuticals Limited, her suggestions have added immensely to the
value of our work.
With a sense of deep gratitude to the Almighty for blessing us with the necessary skills and
resources, we offer this book to B. Pharm. students from all over the country. We trust this book will
enable them to understand the multiple aspects of QA in the pharma industry. We also hope it will
kindle a sense of pride in being part of the profession of Pharmacy that contributes so greatly to
human welfare.
Anusuya R. Kashi
Bindu Sukumaran
Veena P.
PHARMACEUTICAL
QUALITY ASSURANCE
As Per PCI Regulations
THIRD YEAR B. PHARM.
Semester VI
Anusuya R. Kashi Bindu Sukumaran
Assistant Professor, Assistant Professor,
Vivekananda College of Pharmacy, Vivekananda College of Pharmacy,
nd nd
Dr. Raj Kumar Road, Rajajinagar 2 Stage, Dr. Raj Kumar Road, Rajajinagar 2 Stage,
Bengaluru – 560 055, Karnataka, India Bengaluru – 560 055, Karnataka, India
Venna P.
Assistant Profesor and Vice Principal,
Vivekananda College of Pharmacy,
nd
Dr. Raj Kumar Road, Rajajinagar 2 Stage,
Bengaluru – 560 055, Karnataka, India
Price ` 150.00
N4088
,Pharmaceutical Quality Assurance ISBN 978-93-89825-24-4
First Edition : January 2020
© : Authors
The text of this publication, or any part thereof, should not be reproduced or transmitted in any form or stored in any computer
storage system or device for distribution including photocopy, recording, taping or information retrieval system or reproduced on any disc,
tape, perforated media or other information storage device etc., without the written permission of Authors with whom the rights are
reserved. Breach of this condition is liable for legal action.
Every effort has been made to avoid errors or omissions in this publication. In spite of this, errors may have crept in. Any mistake, error
or discrepancy so noted and shall be brought to our notice shall be taken care of in the next edition. It is notified that neither the publisher
nor the authors or seller shall be responsible for any damage or loss of action to any one, of any kind, in any manner, therefrom.
Published By : Polyplate Printed By :
NIRALI PRAKASHAN YOGIRAJ PRINTERS AND BINDERS
Abhyudaya Pragati, 1312, Shivaji Nagar, Works: Sr. No. 10\1,Ghule Industrial Estate,
Off J.M. Road, PUNE – 411005 Nanded Village Road,
Tel - (020) 25512336/37/39, Fax - (020) 25511379 TAL-HAVELI, DIT-PUNE 411041.
Email : Mobile - 9850046517, 9404225254
DISTRIBUTION CENTRES
PUNE
Nirali Prakashan : 119, Budhwar Peth, Jogeshwari Mandir Lane, Pune 411002, Maharashtra
(For orders within Pune) Tel : (020) 2445 2044, Fax : (020) 2445 1538; Mobile : 9657703145
Email :
Nirali Prakashan : S. No. 28/27, Dhayari, Near Asian College Pune 411041
(For orders outside Pune) Tel : (020) 24690204 Fax : (020) 24690316; Mobile : 9657703143
Email :
MUMBAI
Nirali Prakashan : 385, S.V.P. Road, Rasdhara Co-op. Hsg. Society Ltd.,
Girgaum, Mumbai 400004, Maharashtra; Mobile : 9320129587
Tel : (022) 2385 9976, Fax : (022) 2386 9976
Email :
DISTRIBUTION BRANCHES
JALGAON
Nirali Prakashan : 34, V. V. Golani Market, Navi Peth, Jalgaon 425001, Maharashtra,
Tel : (0257) 222 0395, Mob : 94234 91860; Email :
KOLHAPUR
Nirali Prakashan : New Mahadvar Road, Kedar Plaza, 1st Floor Opp. IDBI Bank, Kolhapur 416 012
Maharashtra. Mob : 9850046155; Email :
NAGPUR
Nirali Prakashan : Above Maratha Mandir, Shop No. 3, First Floor,
Rani Jhanshi Square, Sitabuldi, Nagpur 440012, Maharashtra
Tel : (0712) 254 7129; Email :
DELHI
Nirali Prakashan : 4593/15, Basement, Agarwal Lane, Ansari Road, Daryaganj
Near Times of India Building, New Delhi 110002 Mob : 08505972553
Email :
BENGALURU
Nirali Prakashan : Maitri Ground Floor, Jaya Apartments, No. 99, 6th Cross, 6th Main,
Malleswaram, Bengaluru 560003, Karnataka; Mob : 9449043034
Email:
Other Branches : Hyderabad, Chennai
Note: Every possible effort has been made to avoid errors or omissions in this book. In spite this, errors may have crept in. Any type of error
or mistake so noted, and shall be brought to our notice, shall be taken care of in the next edition. It is notified that neither the publisher, nor
the author or book seller shall be responsible for any damage or loss of action to any one of any kind, in any manner, therefrom. The reader
must cross check all the facts and contents with original Government notification or publications.
| www.pragationline.com
Also find us on www.facebook.com/niralibooks
, Preface
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
While quality is the single-most important requirement for any product, it becomes even more
critical in the pharmaceutical industry where patients rely on medicines to cure, prevent and mitigate
diseases. From the times when mere quality control testing was sufficient to approve products as fit for
use, we have now progressed to the realization that quality must be built into drug products from the
very initial design phase. Quality assurance (QA) comprises the sum total of all that goes into ensuring
that products manufactured are of the intended quality that makes them fit for use. Understanding
the several different aspects of QA is therefore a vital first step in working towards attaining desired
quality products.
It gives us great pleasure to present this Textbook of Pharmaceutical Quality Assurance to the
students of the B. Pharm. course. It has been our endeavour to make the content student-friendly and
towards this end, we have included objectives at the beginning and review questions at the end of
each chapter. While we have tried to verify all details provided in this book, it is quite possible that
some information may need greater clarity or amendment – if you, the readers, notice any errors or
scope for improvement, we will be most obliged to receive your feedback and suggestions.
For teachers, explaining concepts in a classroom is very easy; writing the same content in a lucid
style that holds students’ attention is definitely more challenging. We thank our family and friends for
their encouragement in achieving this milestone. We express special thanks to Mr. R. E. Narayana, our
senior librarian in the Vivekananda College of Pharmacy who put us in touch with Mr. Ramakrishna of
Nirali Prakashan and sowed the initial idea of writing this textbook. Their encouragement has been
instrumental in guiding our efforts. It has also been a pleasure to work with Ms. Roshan Khan,
Co-ordinator of Pharmacy Department of Nirali Prakashan.
We are grateful to the management of the Janatha Education Society for their support to this
venture. We are deeply grateful to our college Principal, Dr. D. Narasimha Reddy, for his constant
support and guidance.
We also take this opportunity to thank Ms. Vasundhara Rama Iyengar for her help in structuring
the content of this textbook. With close to 30 years of service in the pharmaceutical industry, having
served as the Quality Head in reputed pharmaceutical companies such as AstraZeneca Pharma India
Limited and GlaxoSmithKline Pharmaceuticals Limited, her suggestions have added immensely to the
value of our work.
With a sense of deep gratitude to the Almighty for blessing us with the necessary skills and
resources, we offer this book to B. Pharm. students from all over the country. We trust this book will
enable them to understand the multiple aspects of QA in the pharma industry. We also hope it will
kindle a sense of pride in being part of the profession of Pharmacy that contributes so greatly to
human welfare.
Anusuya R. Kashi
Bindu Sukumaran
Veena P.
