Pharmaceutical Technology - October 2021

Pharmaceutical_Technology_Oct_2021_API

Issue link: https://www.e-digitaleditions.com/i/1420709

Contents of this Issue

Navigation

Page 65 of 68

Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 65 change history, with interconnection with other topics for the same or other products. Of course, reference to quality system documentation could be used to avoid unnecessary repetitions. For in- stance, using the above-mentioned example of the change in specification for the peroxide content of an excipient, this change could be traced in the section dedicated to raw materials and referenced to both the deviation report, which includes all the investigations bringing to the change, and the file managing the corresponding supplier change. Reference could also be made to all other impacted products and processes, if any. Knowledge management and innovation In today's complex pharmaceutical business world, quality and innovation are the drivers for profit- able revenue growth and long-term sustainability. Now more than ever, partnership and collabora- tion are essential to advance drug delivery innova- tion. There are several definitions of innovation in the literature, but the ones that best clarify the role of knowledge management in innovation are those that look at innovation as a process of knowledge. Simply stated, innovation is the creation of new knowledge, and this could in turn result in changes in the organization's knowledge system (5,10–11). Interestingly, in some of these papers, a distinction is made between radical and incremental innova- tion. The former is a sort of line extension of an ex- isting product, while the latter involves the applica- tion of new technologies. Incremental innovation is more tactical while radical innovation is key to long-term success. Thinking of the pharmaceutical world, the improvements that typically occur in technology transfer activities and/or in the man- ufacturing phase of a product are an example of incremental innovation. This innovation testifies to increases of knowledge typically associated with the concept of continual improvement throughout the life cycle of a product. Whereas, continuous manufacturing or process analytical technology belong to the category of radical innovation. Based on the authors' experience, knowledge management can promote innovation according to the following drivers: • Knowledge management creates an open and transparent system favoring relationship build- ing and people interactions. This means acquir- ing knowledge through collaboration which, in turn, is a way to innovation. • In current market scenario of intense competi- tion, the industry is being forced to innovate to maintain this success. Innovation is strictly dependent on the availability of knowledge and has become increasingly complex. There- fore, this complexity can be managed by knowledge management. • Knowledge management favors the integration of internal and external knowledge, thus making it more easily accessible and helping the conversion from tacit to explicit knowledge. • Knowledge management favors collaboration, which means that knowledge can be shared and enriched. The skills acquired through collabora- tion make innovative solutions more easily avail- able, and this is particularly important in the de- velopment of a new product and in fields where there is relatively little explicit knowledge, such as gene therapy or cell therapy. Knowledge dissemination An effective dissemination system has to be imple- mented in the company to avoid knowledge loss

Articles in this issue

Archives of this issue

view archives of Pharmaceutical Technology - October 2021 - Pharmaceutical_Technology_Oct_2021_API