Technology Transfer And The Climate Of Change
August 2008
TLDR The document concludes that a Quality Management System is crucial for maintaining product quality through innovation and proper technology transfer in the pharmaceutical industry.
The document discusses the importance of technology transfer in the pharmaceutical industry, emphasizing the need for continuous improvement and innovation to maintain high-quality standards in product development. It outlines the Quality Management System (QMS) as a strategy that encompasses both Research and Development (R&D) and Quality Assurance (QA) to ensure product quality. The document highlights the three golden rules of good practice: honesty, rigor, and a sound scientific basis. It also introduces the 'maintain, improve or innovate' cycle (MII), suggesting that innovation offers competitive advantages and potentially superior products. The text acknowledges the role of serendipity in discovering groundbreaking medicines, citing examples like Minoxidil for hair restoration and Viagra™ for erectile dysfunction. Additionally, it stresses the importance of proper method transfer, including manufacturing validation and analytical and clinical methods validation, to maintain product quality throughout the development process. The document underscores the challenges of technology transfer due to the complexity of the process and the number of personnel involved, advocating for a QMS to facilitate smooth transitions.
