Drug Product Manufacturing Process: Technology Transfer

ISBN-13: 9783031322198 / Angielski

Ajay Babu Pazhayattil; Sanjay Sharma; Joe Paul Philip

Spis treści

Chapter 1: Current Status of Technology Transfer

Chapter 2: Quality by Design (QbD) Process Design

Chapter 3: Quality Risk Management (QRM)

Chapter 4: Technology Transfer Process

Chapter 5: Scaling-Up of Solid Orals: Granulation, Drying, Size Reduction, Blending, Compression, and Coating Technologies

Chapter 6: Qualification, Continued Process Verification, and Lifecycle Management

Chapter 7: Continuous Improvement Case Study: Transforming Legacy Products

 

Appendix 1- Technology Transfer Documents (TTD) Checklist

Appendix II- Technology Transfer Protocol (TTP)

Appendix III- Checklist for First Exhibit Batch Start-Up

Appendix IV- Case Study of Roller Compaction Process From Development To Scale-Up 

O autorze

Dr. Ajay Babu Pazhayattil, Pharmaceutical Consultant, Toronto, Canada

Dr. Ajay Babu Pazhayattil is a highly experienced pharmaceutical professional with a strong background in industrial pharmacy and executive management. He has a track record of driving innovation for brand, generic, and CDMO pharmaceutical organizations. He is known for his data-driven, regulatory-compliant approach to formulation and is well-respected in the industry. He is actively involved in industry organizations and is recognized as a thought leader in the field, having made significant contributions through published journal articles and textbooks.

 

Sanjay Sharma, Senior Vice President & Head Manufacturing Science and Technology, Zydus

Sanjay is a seasoned pharmaceutical industry professional with over 23 years of experience in the development, launch, and maintenance of drug supply. He possesses a results-driven approach and a deep understanding of pharmaceutical manufacturing science, which has enabled him to contribute to the success of some of the largest organizations in the industry. Sanjay has held various leadership positions in Indian and multinational pharmaceutical companies such as Cipla, Dr. Reddy's Laboratories, Sandoz, Watson, Torrent, and Lupin.

 

Joe Paul Philip, Joe Paul Philip, Vice President & Head, Global Process Excellence and New Products, Glenmark Pharmaceuticals

Joe Paul Philip has over 20 years of experience in Technical and Strategic Leadership roles, specifically in Life Cycle Management of Formulations. He has experience leading multicultural teams globally and expertise in Process Development, New Product Launches, Technical Services, R&D Technology Transfers, Global Technology Transfers, Process Validations, Computer System Validations, Equipment Qualifications, Technical Investigation, Root Cause Analysis, and Data Analytics for OSD, Parenteral & Semi-solid technology platforms. He also has experience and knowledge in negotiating development/commercial agreements.

 

Michelle Gischewski-Silva, Scientific Advisor, Eurofins Alphora, Alphora Research Inc

As a highly experienced and accomplished leader in the pharmaceutical industry, Michelle brings a wealth of knowledge and expertise to her role. With a solid background in critical new product development projects, she possesses deep technical knowledge in R&D formulation development, scale-up, process validation, and technology transfer of solid and liquid dosages. As the head of the formulation, she was responsible for optimizing formulations and streamlining processes to ensure robustness.

 

Marzena Ingram, Senior Consultant, Validant Inc.

Marzena Ingram is an experienced independent senior pharmaceutical consultant who specializes in quality and technical operations for solid-dose and active pharmaceutical ingredient manufacturing. She helps clients address FDA warning letter scenarios. She has developed a specialized team for continued process verification. She has also implemented programs to meet global regulatory requirements, developed and published statistical tools for pharmaceutical manufacturing processes, and led the implementation of a comprehensive life cycle management software. Marzena is a board member of ISPE Canada.

Blurb

Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance.
This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirements of the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook’s authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.