An investment in knowledge pays the best interest
-- Benjamin Franklin
Since 2008 and the publication of ICH Q10, the importance of the role of knowledge management has been clearly positioned as one of two key enablers necessary for the successful implementation of an effective pharmaceutical quality system. In the intervening years, many organizations have engaged in earnest on their quest to manage the knowledge locked within.
Last November, at ISPE’s Annual Meeting in Washington, there was much buzz among the delegates about the article in Pharmaceutical Engineering on a case study from Merck on their Knowledge Management (KM) evolution. In a meeting I had with Gloria Hall, Editor and Director of Publications at ISPE, we discussed the fact that while the regulators had set out their high- level expectations for knowledge management, the industry was still grappling with how to deliver real programs that address the many complexities of capturing, converting and communicating the existing and emerging knowledge within their organizations. The seed was sown for us to start work on a dedicated Pharmaceutical Engineering E-supplement on knowledge management in the pharmaceutical industry.
This supplement will be available for download in May. As a researcher in the field of ICH Q8-Q11 implementation and longtime ISPE volunteer, I was happy to take on the task of ‘curating’ the supplement and set about seeking diverse inputs from regulators, industry, service providers and academia. What I found was a real appetite for sharing experience, current practice and practical resources. ISPE now brings to you ten thought provoking contributions on the subject of managing knowledge including:
Much has been written in recent years about the knowledge continuum (data, information, understanding, knowledge and wisdom). Ultimately, in our industry, wisdom lies in our ability to recognize the role that knowledge plays in enhancing our patient-focused decision making capabilities in every batch, every day. ISPE hopes that this supplement will invigorate an industry dialog on knowledge management. We welcome your feedback and suggestions.
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...
Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...
