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66 Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 P h a r mTe c h . c o m Quality and dispersion. One simple way to disseminate knowledge is through a training program, which each company must have in place to be GxP com- pliant. It is essential that the training program does not only reiterate the information currently available at the company or current regulatory or GxP requirements but is continuously updated by subject matter experts. Regarding GxP require- ments, it seems useful to have a regular review on news and trends, even if not strictly related to the operations ongoing at the company. For instance, a company operating in the field of non-sterile products would definitely benefit by a general training on requirements for sterile production. A company manufacturing small molecules could get good ideas for improvement in knowing what the requirements to produce biotech products are. In respect of GxP regulations, it is important to establish a systematic monitoring program to be continually updated on new regulations and re- quirements, even in draft form, at least for the area of operations. The most important organizations publishing norms and guidelines (e.g., European Medicines Agency, US Food and Drug Adminis- tration, ICH, Pharmaceutical Inspection Conven- tion and Pharmaceutical Inspection Co-operation Scheme, World Health Organization, European Pharmacopoeia, United States Pharmacopeia) as well as professional and industry organizations (e.g., Parenteral Drug Association, International Society for Pharmaceutical Engineering, Associa- tions for Professionals in Infection Control and Epidemiology, International Pharmaceutical Ex- cipients Council, International Organization for Standardization) must be continuously monitored for new publications. The information about new requirements or trends must be timely dissemi- nated to all potentially interested people in the company (e.g., by means of emails, newsletters, and/or regular update meetings). Oral dissemination is also important; short briefings on new technologies, frequently associ- ated with new development projects running at the company, could be organized to inform and trans- fer knowledge to people not directly involved. Reg- ular information exchange sessions could involve the attendance of different company functions and departments, where each participant could pres- ent on ongoing projects and share experiences and knowledge gained through day-to-day activities. The same approach could be used to disseminate information gained at external events, such as con- gresses, meetings, or courses. Knowledge loss There are many situations where scientific, tech- nological, and GxP/regulatory knowledge may be lost. Typical examples in the pharma industry are subject matter experts leaving the company, product transfer from development to commercial production, product transfer to contract manufac- turing organizations (CMOs) or other manufac- turing sites, and product discontinuation. Another critical situation may be a company acquisition or change of ownership. The key issue is almost always the change in product/process ownership; knowledge is not al- ways and completely transferred when responsi- bility for the product/process is transferred. This issue is common when knowledge is documented in a very fragmented way; some pieces of the puzzle can be lost. The puzzle's integrity must be maintained during transfer. Therefore, it is recom- mended that the scientific and technological know-