Process Understanding For Scale

The book offers a comprehensive overview of the unit operations involved in the manufacturing process of solid and liquid dosage forms, along with the scale-up of each operation. This book is a valuable resource for professionals working in the pharmaceutical industry and researchers seeking to develop a comprehensive understanding of the various aspects of the manufacturing process.

A practical guide on how to scale businesses in practice fast and efficiently

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.

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