Pharmaceutical Technology - October 2021


Issue link:

Contents of this Issue


Page 60 of 68

60 Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 P h a r mTe c h . c o m Quality ing that these activities are mostly team based, and the necessary knowledge must be efficiently made available and shared between the different people within the team to ensure success. All the above-mentioned considerations are in- cluded in the International Council for Harmonisa- tion (ICH) Q10 guideline on Pharmaceutical Quality System (1). In chapter 1.6.1, knowledge management is described as follows: "Product and process knowledge should be man- aged from development through the commercial life of the product up to and including product dis- continuation. For example, development activities using scientific approaches provide knowledge for product and process understanding. Knowledge management is a systematic approach to acquiring, analysing, storing and disseminating information related to products, manufacturing processes and components. Sources of knowledge include, but are not limited to prior knowledge (public domain or internally documented); pharmaceutical develop- ment studies; technology transfer activities; process validation studies over the product lifecycle; manu- facturing experience; innovation; continual im- provement; and change management activities" (1). Types of knowledge To be efficient, any organization should not only process information but also create information and knowledge. Though often used interchangeably, knowledge and information are not the same thing. Knowledge is neither data nor information, though it is related to both (2). All organizations need data, but data give only a partial description of a situation, though it is important because it is the 'raw material' which, after contextualization, creates information. In the same way, information is a flow of messages that, after using logical deductions and consolida- tion, becomes knowledge. Knowledge develops over time, through experience. At last, expertise is the efficient use of knowledge. The hierarchy is graphi- cally expressed in Figure 1. As an example, when the ICH Q10 guideline defines the goal of technology transfer activities, the term knowledge rather than information is ap- propriately used: "[…] the goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization" (1). Types of knowledge in the pharmaceutical industry Several types of knowledge can be identified in the pharmaceutical industry. Product/process and quality system knowledge. Knowl- edge related to product/process is of a scientific–tech- nical nature, is typically developed and gained during product and process development, and is captured and maintained in technical documentation such as quality specifications, manufacturing methods, qualification, and validation reports. This type of knowledge is typi- cally transferred from development functions to man- ufacturing departments during scale-up and indus- trialization steps of product lifecycle. It might also be transferred from one manufacturing site to the other during technology transfers in the marketing phase of the product. Product/process knowledge typically in- creases rapidly during development to reach a plateau in the commercial phase; however, during the lifecycle Figure 1. The scale of knowledge. FIGURES COURTESY OF THE AUTHORS

Articles in this issue

Links on this page

Archives of this issue

view archives of Pharmaceutical Technology - October 2021 - Pharmaceutical_Technology_Oct_2021_API