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64 Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 P h a r mTe c h . c o m Quality let. Typically, a pre-blending of the active ingredient with an excipient is used to ensure good uniformity of the final mixture. In this case, technical discus- sions with manufacturers/suppliers of excipients can be extremely useful, not only for the selection of the most appropriate grade of a given excipient but also for process optimization. Aspects such as previous experi- ence and thorough practical knowledge of the material characteristics usually play a key role in making the best decision. But this type of knowledge is something that is not easily retrievable in textbooks and can be considered as a typical example of tacit knowledge, which can be converted to explicit thanks to interac- tions between people. Also, it is believed that this ex- ample clarifies the difference between information and knowledge and highlights a key aspect of knowledge that it is related to human actions. Knowledge documentation The easiest way to capture knowledge and to make it available to all potential beneficiaries is its incorpo- ration into the quality system documentation imple- mented in the company. New information, data, and results can be included, as applicable and appropri- ate, in procedures, working instructions, methods, specifications, reports, and so on. The advantage of this system is that knowledge is consolidated in the company and that the necessary information and training of all appropriate personnel is already or- ganized according to company procedures and pro- cesses. Good examples would be a new analytical method or a new tool for risk analysis, which would be respectively included in new versions of analytical methods or risk management procedures. Unfortunately, this system is not applicable to and not suitable for all types of new knowledge made available at the company. For instance, while it is quite easy to update a raw material quality specifica- tion, justify it, and make the information available to all involved personnel, it might be more difficult to record and trace all the steps and the processes that led the company to the change. Additionally, that change would likely be treated individually with- out any correlation with other similar or connected changes implemented on the same or other materi- als. For instance, the change in specification for per- oxide content of a raw material could originate from a deviation or non-conformity experienced in batch manufacturing, be the outcome of lengthy and com- plex investigations, and be applicable to some for- mulations and not to others. It is difficult to assure that the traceability of the development of this type of knowledge increases for all products managed by a company and all over a long period of time. Prod- uct quality reviews/annual product reviews partially fulfill these requirements. They include all changes, deviations, complaints, and quality events impact- ing a product; however, they do normally cover a 12-month period and are limited to one product only. In addition, their contents are strictly defined by correspondent regulations (EU GMP or US 21 Code of Federal Regulations) and not always suitable to capture all knowledge collected on the product and process during the period covered. The ideal document to collect and update the knowledge gained must be designed to cover the entire lifecycle of a product and related processes, from the early formulation studies until the termi- nation of commercial manufacturing. The docu- ment could be defined as the 'product lifecycle file' and could be organized by topics (e.g., raw ma- terials, packaging materials, production process, analy tical methods, analy tical specifications). Each topic (and subtopic) could describe all the