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Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 67 how is consolidated as much as possible into one or a few documents. One document is easier to transfer without any loss of information, compared with many different documents belonging to different company areas and functions. It is of utmost importance that these few documents collecting the vital information for our products and processes are kept updated dur- ing the ownership change. Very often the ownership change itself generates new knowledge (e.g., in tech- nology transfer projects); this new knowledge must be included in the documentation in a timely fashion. Loss of knowledge due to people leaving the com- pany or retiring can be prevented with a well-orga- nized succession planning or back-up program. These programs identify persons that can substitute in the short-, medium-, or long-term persons in charge of key positions in the company; it is important that this program not only covers hierarchical positions, as it is often the case, but also key subject matter experts, even if not positioned high in the hierarchy. In other words, a 'knowledge back-up or succession plan' must be in place and continuously updated. Successors and back-ups should not only be trained by the subject matter experts but should also receive organized and planned scientific and/or GxP training. Conclusion The increased complexity of the pharmaceutical environment makes knowledge management an essential requirement. Mergers and acquisitions undoubtedly bring opportunities, but they also raise challenges. Troubleshooting across a prod- uct lifecycle also provides the opportunity for con- tinual improvement. ICH Q10 recognizes the key role played by the technology transfer process for its interposition between development (where the knowledge is created) and manufacturing (where product quality must be under control), or between manufacturing sites to achieve product realization. However, without the implementation of a skillful efficient knowledge management system, allowing people to interact directly, all these aspects would bring inefficiencies which, in turn, would lead to missed business opportunities. People should perceive knowledge management as a routine part of their daily work. This is a cul- tural change and cultural changes are not easy to implement, they take time. Thus, knowledge man- agement requires strong sponsorship first from se- nior management. Only a small part of the huge amount of infor- mation created by the pharmaceutical industry is utilized effectively. Knowledge management helps generate an integrated source of information. The requirement is not to convert all the tacit knowl- edge into explicit knowledge, but rather to cre- ate a knowledge-driven culture, which promotes innovation. This is vital to provide competitive advantage. References 1. ICH, Q10 Pharmaceutical Quality System, Current Step 4 Ver- sion (ICH, 2008). 2. T.H. Davenport and L. Prusak, "Working Knowledge: How Organizations Manage What they Know," Ubiquity, Research Article, Aug. 1, 2000. 3. ICH, Q8(R2) Pharmaceutical Development, Current Step 4 Version (ICH, 2009). 4. I. Nonaka, Organ. Sci. 5 (1) 14-37 (1994). 5. P.V. Søberg and A. Chaudhuri, Knowl. Process Manag. 25 (2) 88-96 (2018). 6. ISPE, "Knowledge Management," a Supplement to Pharma- ceutical Engineering (May 2014) 7. N. Calnan, "The 80/20 Rule of Knowledge," in Supplement to Pharmaceutical Engineering, pp. 54–58 (May 2014). 8. EC, EudraLex Volume 4, Annex 15: Qualification and Valida- tion (Brussels, March 2015). 9. ICH, Q9 Quality Risk Management, Current Step 4 Version (2005). 10. M. Du Plessis, J. Knowl. Manag. 11 (4) 20-29 (2007). 11. M. Gloet and M. Terziovski, J. Manuf. Technol. Manag. 15 (5) 402-409 (2004). PT