The global pharmaceutical market is valued at 1.27 trillion US dollars based on 2020 reports. Industry players need to focus on quality and innovation, the primary drivers for successful revenue growth and long-term sustainability in the increasingly complex pharmaceutical business. Knowledge management and knowledge sharing provide the required competitive advantage.
Knowledge management in a Pharmaceutical Quality System is defined as “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 development studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities.”
Knowledge management has always been the pillar of pharmaceutical development and manufacturing. Knowledge of the chemical components and physical processes involved in drug product formulation, production, and storage guarantees their quality, safety, and efficacy. Knowledge drives the design of dosage forms in choosing excipients and packaging materials and implementing manufacturing processes.
Pharmaceutical knowledge is a complex, multifaceted blend of chemistry, physics, microbiology, biology, analytics, materials properties, process technology, pharmacokinetics, pharmacology, toxicology, and physiology. All this “traditional” knowledge must be integrated with a practical understanding of information technology, data management, and data processing. Additionally, in highly specialised disciplines like advanced therapy and biotech, specific knowledge like cell engineering and genomics are further required. Scientific pharmaceutical knowledge must be paired with proficiency in project management, risk analysis, budgeting, and a thorough understanding of regulatory activities to succeed in the pharmaceutical industry.
An efficient organisation processes and generates information and develops knowledge. Although usually used synonymously, knowledge and information are two separate things. Knowledge is not information or data; however, it is related to both. Data is a limited representation of any given situation but, through contextualisation, creates information. And information as a flow of data, following logical reasoning and consolidation, develops into knowledge. Over time and through experience, knowledge becomes expertise.
To fully understand the roles of knowledge sharing and knowledge management in pharma, it is essential to know how pharmaceutical knowledge is obtained, handled, and implemented in practice.
The current knowledge capture system in the industry revolves around good manufacturing practice documentation requirements that also include incorporating new information, data and results, as applicable in operating procedures, working instructions, testing methods, specifications, and reports. Knowledge is organised according to company procedures and processes alongside other necessary information such as related personnel training, updates on newer analytical methods, or risk management procedures. Regrettably, this system is not suitable for all types of knowledge procured. For any changes made in procedures or specifications of a process or product, there is a limit on data traceability leading to knowledge change.
In the technical context, innovation is a knowledge process. Innovation is simply creating new knowledge, which could disrupt a company’s knowledge system. There are two types of innovation: incremental and radical. In the pharmaceutical industry, incremental innovation is about continuous improvements in an existing product’s technology transfer or manufacturing activities. In contrast, radical innovation involves radical shifts in a medicinal product’s manufacturing methods or technological processes. Where incremental innovation is more aligned to long-term success and longevity, radical innovation is more tactical in introducing new technology, processes or practices that could displace older ones. Either way, the process of innovation is a huge part of gaining knowledge associated with the continual improvement of a product throughout its lifecycle.
There are nine known knowledge sharing mechanisms within a pharmaceutical company: documentation, education and training, standard operating procedures, recognition of work, routine and non-routine meetings, seminars and conferences, show and tell, staff updates, and voluntary mentoring. The lack of formal knowledge management of these mechanisms results in inefficient knowledge sharing.
A typical system of sharing knowledge is through training programs that are Good Practice compliant. Pharmaceutical companies usually struggle to keep up with their internal monitoring programs that deal with Good Practice as regulations and requirements get updated constantly with multiple organisations publishing guidelines. Regulatory organisations include the European Medicines Agency, US Food and Drug Administration, The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme, World Health
Organisation, European Pharmacopoeia, United States Pharmacopoeia. Professional organisations include the Parenteral Drug Association, International Society for Pharmaceutical Engineering, Associations for Professionals in Infection Control and Epidemiology, International Pharmaceutical Excipients Council, and International Organisation for Standardisation. New information is usually disseminated through emails, newsletters and update meetings. But because of inefficient knowledge sharing systems in place, time-sensitive information is not given to the correct people at the right time.
The pharmaceutical industry is uniquely regulated and highly competitive. The culture of competitiveness is apparent even within pharmaceutical organisations. For a pharmaceutical company to stay relevant in the industry, they have to be innovative and high-quality producing. On top of that, they also have to be able to improve their time-to-market. This is where knowledge sharing enters the picture: knowledge sharing enriches knowledge creation, enabling the development of innovative products at a more incredible speed.
Presently, pharmaceutical companies utilise only a tiny portion of their knowledge. A cultural shift is needed to optimise the wealth of information and turn it into an integrated pharmaceutical knowledge source. A comprehensive knowledge-sharing platform like Elium implements an efficient knowledge management system in your company. It allows the direct interaction of employees to create the innovation your pharmaceutical company needs.