Technology Transfer

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 requirementsof 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.

Only reference to address a systematic approach to Transfer Stage 1b technology Concise essential professional reference for drug manufacturers Covers systematic compliance to all regulations

Autorentext
Dr. Ajay Babu Pazhayattil, President, cGMPWorld, Toronto, Canada Dr. Ajay Pazhayattil is an accomplished management consultant and industrial pharmacist with extensive experience spanning solid oral, sterile, and API manufacturing sectors. He is the founder of cGMP World and a founding partner of ITAAN Pharma, an injectable manufacturer. Dr. Pazhayattil has held key leadership positions with prominent North American brands, generic manufacturers, and CDMOs. His roles include Vice President of Scientific and Regulatory Affairs at Capcium, Quality Director at Eurofins, and Associate Director at Apotex. He plays a pivotal role in guiding organizations through remediation efforts related to US FDA 483 observations and warning letters. He has been a lead author and contributor to industry guidance documents published by renowned industry organizations such as AAPS, PDA, ISPE, and RAPS. Sanjay Sharma, Senior Vice President and Head, Manufacturing Science and Technology, Zydus Group, Ahmedabad, India Sanjay is a seasoned pharmaceutical industry professional with over 25 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. He is widely recognized for his expertise in streamlining technical operations and driving innovation to enhance product quality and regulatory compliance.

Inhalt

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.