Introducing the groundbreaking textbook on drug product manufacturing technology transfer! Written by industry experts Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, and Marzena Ingram, this comprehensive guide provides pharmaceutical professionals with the latest regulatory expectations and guidance for technology transfer in the pharmaceutical industry.

In today’s global pharmaceutical market, regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), World Health Organization (WHO), and Pharmaceutical Inspection Co-operation Scheme (PIC/S) have adopted the International Conference on Harmonization (ICH) Lifecycle approach. This approach harmonizes concepts across regulatory guidance, allowing organizations to align their technology transfer activities for all regulated markets. However, there is a lack of consensus and direction in approaching technology transfer, particularly in managing the scale-up effects to ensure regulatory compliance.

This textbook fills that gap by offering practical solutions and guidance for technology transfer challenges in the pharmaceutical industry. The authors provide a systematic understanding of applying technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. While the regulatory guidance covers the stages of technology transfer, such as Stage 1 (Technology Transfer Plan) and Stage 2 (Process Performance Qualification), Stage 1b (Process Design) is not specified in detail. Pharmaceutical organizations are left to determine the requirements of this stage, making it more demanding to justify methodologies and utilize sound science.

With this textbook, the authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document for pharmaceutical professionals. The approaches described can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.

Why You Should Order This Book

Ordering this book is an essential step for pharmaceutical professionals who want to stay up-to-date with the latest regulatory expectations and guidance for technology transfer. Here are some reasons why you should order this book:

1. Comprehensive Coverage

This textbook covers all aspects of technology transfer in the pharmaceutical industry, providing a comprehensive understanding of the subject. From regulatory expectations to scale-up effects management, the book offers solutions and guidance for every stage of the technology transfer process.

2. Expert Authorship

The authors of this textbook are industry experts with years of experience in pharmaceutical manufacturing and technology transfer. Their expertise and knowledge shine through in the detailed explanations and practical examples provided in the book.

3. Alignment with Regulatory Bodies

The authors have incorporated the latest guidance from regulatory bodies such as the FDA, EMA, WHO, and PIC/S into this textbook. By following the recommendations and best practices outlined in the book, pharmaceutical professionals can ensure compliance with regulatory requirements.

4. Standardization Promotion

Standardization is crucial in the pharmaceutical industry to ensure consistent product quality and regulatory compliance. This textbook promotes standardization within the industry by providing systematic approaches and methodologies for technology transfer.

5. Unmet Needs Addressed

The approaches and solutions described in this textbook address the unmet needs of the pharmaceutical industry in technology transfer. Whether you work in small-molecule or large-molecule drug product manufacturing, this book offers valuable insights for overcoming challenges.

Don’t miss out on the opportunity to enhance your knowledge and skills in technology transfer. Order your copy of this groundbreaking textbook today and become a leader in the pharmaceutical industry!

About the Authors

Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, and Marzena Ingram are experienced professionals in the pharmaceutical industry. They have worked extensively in technology transfer and pharmaceutical manufacturing, gaining insights and expertise that they share in this textbook.

Product Details:

• Publisher: Springer; 1st ed. 2023 edition (June 22, 2023)
• Language: English
• eBook Digital: 120 pages
• ISBN-10: 3031322193
• ISBN-13: 978-3031322198