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Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 63 vices (e.g., in the area of qualification and validation or analytical testing) and with external subject matter experts and consultants. Self-training on scientific and technological literature and on new or revised guidelines issued by professional/industry asso- ciations or by authorities may also be regarded as a source of external acquisition of knowledge. Partici- pation in interest or discussion groups in professional and industry associations on specific topics is another route to gain externally acquired knowledge. Externally acquired knowledge is typically more difficult to capture in the company quality system because it needs to be stored/retrieved/changed dif- ferently from the knowledge acquired over the years by a company formulation scientist or a manufactur- ing engineer. However, quantum leaps in company know-how are often obtained through external ex- perience and competence. Categorization of knowledge. Many authors have dealt with the process of knowledge creation. Knowledge has been classified into various categories; for exam- ple it has been categorized as explicit, implicit, or tacit, while other authors refer to implicit, explicit, proce- dural, declarative, or strategic knowledge. However, this is not the goal of this paper and the reader is re- ferred to the literature on the subject (2,4–7). Distinc- tion between tacit knowledge and explicit knowledge is commonly found in many publications. Although sim- plistic, this classification is very useful for the purpose of this paper. In simple terms, 'explicit' is transmittable knowledge while 'tacit' is what is in everyone's head. Explicit knowledge is easily documented and captured for example in protocols, reports, procedures, and so on. Tacit knowledge is person-related and, therefore, is hard to formalize and transfer. There are no doubts that between 2001 and 2015 knowledge management became an important topic for regulators in the manufacture of medicinal prod- ucts. For example, this topic was not mentioned at all in the 2001 version of the European Union (EU) GMP Annex 15 (Qualification and Validation), while the term 'knowledge' is reported several times in the 2015 current version (8), which also includes a definition of knowledge management in its glossary section. Other guidelines, such as ICH Q8 (Pharmaceutical Develop- ment) and ICH Q9 (Quality Risk Management) (3,9) emphasize the concept of scientific knowledge. This alignment between knowledge and science is referred to the explicit knowledge, while the concept of tacit knowledge is a bit lacking. Also, there are no doubts that the highly regulated environment of the pharma- ceutical industry has traditionally given higher value to the explicit knowledge (in its standard operating procedures [SOPs], reports, specifications, best prac- tices, training, etc.). From this perspective, ICH Q10 is the turning point as it not only refers to the 'infor- mation', which is explicit knowledge-related, but also emphasizes concepts such as 'product and process un- derstanding', 'manufacturing experience', 'innovation', 'continual improvement', and 'change management ac- tivities', which are clearly tacit knowledge-related. Both types of knowledge, explicit and tacit, are required for a project to be successful. However, ac- cording to the so-called 80/20 rule of knowledge (7), the majority (approximately 80%) of knowledge is tacit, and therefore linked to experience and exper- tise, while only 20% is explicit, and therefore easily documented. It is recognized that the latter usually solves approximately 80% of the problems, while the former typically solves about 20% of the higher-grade problems. Knowledge management is key to ensure knowledge flow within organizations. For example, let us assume that we are dealing with the formulation of a low-dose direct compression tab-