Purpose
This interest group has as its main objective to capture the opportunity given by the benchmarking of our experience in Technology Transfer projects; with potential opportunity like TR, articles, position papers, training sections, and lectures.
The group will discuss the technology transfer projects topics, from manufacturing process to analytical transfer, from equipment user requirements definition to process validation, from Contract Manufacturing Organization selection to Business Discontinuity, from appropriateness of the documentation to lesson learnt approach and statistical data analysis, without never forget the ethic behind our job.
Pharmaceutical Technology Transfer Projects consist of planned and controlled actions that are based on well-defined acceptance criteria to convey a Pharma technology with all its attributes from a sending unit to a receiving unit and involve a complex group of internal and external stakeholders. Risks are hidden everywhere; it’s mandatory to have a robust and efficient methodology to identify, mitigate and control them.
For that reason we think a Technology Transfer Interest Group will help all of us find best practices, monitor worldwide trends, analyze clusters of peculiarities based on companies, countries, dosage forms, drug entities.