Blue Ocean of Compliance

A holistic approach towards Achieving Regulatory Compliance for Pharmaceutical Industries with No-Observation

The book employing a one-of-a-kind thought process for achieving compliance with no-observation. It takes you through a guide of Regulatory Inspections elaborated with the US Regulatory Market in regard. This book will not only equip you with regulatory knowledge but will also empower you to solve complicated non-compliances, in context of factors which we do not even think of. The ideas in this book are very simple to understand. They will imbibe in you the seeds of "acting to win" instead of only being good enough to survive.

If you are a Founder, a CEO, Entrepreneur, or anyone in the pharmaceutical industry really: if you are a part of pharmaceutical industry or even are just starting out, this book is a treasure for you.

  • Are you struggling to solve the problems of non-compliances on your site?
  • Even with putting your best technologies, Knowledge, and efforts do you feel clueless?
  • If you want to protect your site from risks & huge losses due to non-compliances,
  • If you want to know the thought process & path which would lead you to qualify a Regulatory Inspection with no-observation in cost-effective way,

What Pharma Leaders Say..

Ranjit Barshikar

Certainly, this book will be very useful not only to the Pharmaceutical Industry but to fresh B. Pharm., M. Pharma, PhD students, ready to enter the Pharmaceutical Industry & planning Start-Up activities all over the World.

Ranjit Barshikar
CEO, QbD International
United Nations Adviser, MPP Geneva
Editorial Board Member of Journal of Generic Medicines, UK
Eric Wesoloski

This book will become a primer for those in quality compliance, across the world to learn, teach, and understand the art of regulated quality compliance.

Eric L. Wesoloski
Global Quality Pharmaceutical Executive
John English

The author has provided many instructive details, along with a desire to guide the reader where they should truly want to go.

John English
HCCP, CVP, MCS, MPS
Florham Park, New Jersey, United States
Member: ISPE, RAPS, ISACA, ASQ
Gopal S Patel

I recommend that any person who is directly or indirectly part of Regulatory Inspection must read this book. This book is going to bring a drastic change in the approach to prepare for USFDA inspection. Do not miss to read this treasure of knowledge and wisdom.

Gopal S. Patel
Vice President - Global Regulatory Affairs
Nivagen Pharmaceuticals, Inc.
Sacramento, California, USA
Dr Rajiv Desai

Blue Ocean of Compliance will pave the way for innovative framework towards compliance and all-time readiness for the regulatory inspections. The book will help in channelizing the understanding of Quality and Compliance for the Pharma professionals.

Dr. Rajiv Desai
Executive Vice President - Global Quality Head Lupin
Dr Vinay Nayak

The author’s writing is inspiring to new generation on how to learn and grow in pharma Industry. She has very carefully narrated her professional experiences and joys and insecurities that come with working with complex personalities and situations.

Dr. Vinay Nayak
Independent Director at Aarti Industries Ltd.
Dr Sanjit Lamba

The Blue Ocean GMP Compliance book provides a powerful, visual, and practical set of frameworks and tools, designed to not only effectively build the Compliance culture of the company, but also help to effectively execute through easy communication. It also provides a framework for a mindset of effective Risk management and guides Pharmaceutical industry professionals and beginners alike. I congratulate Dr. Rupali Paranjape for this great piece of art and science

Dr. Sanjit Singh Lamba
CEO and Director – Biocuris
Foreword by Dr H G Koshia

Blue Ocean of Compliance is a thought process that is going to give a path to Indian manufacturing/pharmaceutical companies to be always ready to be inspected and qualify for regulatory inspection with no observation. This book is a ready reckoner for them to understand & implement the psychology & science of Compliance. This book can have a powerful impact on the mindset & thought process of the people working in the pharmaceutical industry. I recommend this book to every business owner, every drug manufacturer, and every person working in the pharmaceutical industry. I also recommend this book to students who are planning to enter the pharmaceutical industry.

Dr. H. G. Koshia
Commissioner
Office of The Commissioner
Food and Drugs Control Administration,
Gandhinagar, Gujarat, INDIA.
Huz Khorakiwala sir1

After reading this book I felt that every person working in the pharmaceutical industry, every person who owns the pharmaceutical company or serves the pharmaceutical company must read this book. This book is a unique combination of the Author’s experience, an innovative thought process, an innovative framework, and a Quality Culture for the preparation of Regulatory Inspections & Compliance. It has the power to bring transformation in your thought process and hence on the site. In the current scenario when Pharma companies are facing business challenges and huge losses due to non-compliances this book will give them a different angle to overcome their problems. I strongly recommend this book to Founders, CEOs & the intellect of pharma companies. I also feel that Pharma companies must give Dr. Rupali Paranjape the opportunity to implement the Framework of the “Blue Ocean of Compliance” on their sites. I also recommend this book to the future generations of the Pharmaceutical Industry, the students who are going to be part of this industry. They will have a well-expanded-upon idea about Regulatory Inspection.

Dr. Huzaifa Khorakiwala
ED-Wockhardt
Mumbai, Maharashtra, India
Shirish Belapure for website

This book explains the concept of Quality Culture & required attitude toward Compliance. I really liked the way she presented the new Compliance & Quality Culture that has to be developed and sustained, in this book. This book explains many important concepts & complex problems in very simple language such that it becomes easy to understand. This whole book is written to achieve the target of qualifying regulatory inspections with no-observation which is very powerful & impressive. In a few words, this book is a ready reckoner for Pharmaceutical Industry and Pharma Professionals. I recommend this book to every Pharmaceutical Professional. Anyone who is working in the Pharmaceutical Industry, who is having pharmaceutical manufacturing company, who is part of the Pharmaceutical Industry, or who wants to be the part of pharmaceutical industry must read this book. Her Framework named “Blue Ocean of Compliance” and the concept that we should not prepare for audit only when it is due soon & should instead always be ready to be inspected is a unique & powerful thought process. In a few words, this book is a ready reckoner for Pharmaceutical Industry and Pharma Professionals. I recommend this book to every Pharmaceutical Professional.

Shirish Belapure
Senior Technical Advisor at Indian Pharmaceutical Alliance
Ahmedabad, Gujarat, India
Prof Rajendra B Kakde

Blue Ocean of Compliance is the unique combination of Technical Education + Practical Experience + Quality Culture + Thought Process I have ever read. This book is not only useful to experienced pharmaceutical professionals, and owners of the pharma industry but it is also very useful for Pharmacy students and science students who are willing to make a career in the Pharmaceutical Industry. I recommend this book to every person working in the Pharmaceutical Industry, and to every person who is directly or indirectly part of Regulatory Inspect or Audit.

Why you must read this

  • By reading & implementing this you will be able to avoid more than 492, 483s on your site
  • You will be able to avoid many circumstances that lead to Warning letters.
  • You will become more familiar with the enforcement actions, reasons of non-compliances & ways to overcome them in cost-effective ways.
  • You will come to know many factors which might not be discussed before to solve the non-compliance issues on the site.
  • You will know one new thought process Blue Ocean of Compliance
  • At the end of each Chapter Practical Assignments: Exercise is given for implementation.

The beautiful part of the book is, that it is written by an experienced doer that has spent years on the shopfloor in a very simple manner, in easily understandable language with examples, case studies, 492 FDA 483 observations, and many Warning Letter Case studies and much more.

Order Now

The book is available online on:

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