knowledge 2 blog

By: Nuala Calnan

Read the views on the evolution of Knowledge Management in our Regulatory Guidance from Dr. Kevin O’ Donnell, The Irish Medicines Board and Dr. Anne Greene of the Dublin Institute of Technology.

Pharmaceutical regulators have only recently begun addressing the complex subject of Knowledge Management in their guidance documents.   Indeed, in the most recent draft of Annex 15 to the EU Guide to Good Manufacturing Practice on Qualification and Validation (issued for comments on 6th February 2014), the guidance refers to knowledge nine times, and includes a definition for Knowledge Management in its glossary.  Conversely, the current Annex 15 (issued in 2001) has no mention on the topic of knowledge, let alone a definition in the glossary, which leads one to deduce that in the years between 2001 and 2014, Knowledge Management has evolved to become an important issue for regulators in the manufacture of safe and effective medicines.

Learn more about the evolution of knowledge management within the new Science and Risk based paradigm, from the FDA’s Pharmaceutical cGMPs for the 21st Century Initiative (released in August 2002) right through the key ICH guidance documents of Q8, Q9, Q10 and Q11.  O’Donnell and Greene have completed a review of the relevant guidance to summarize the changing landscape of the increasing importance placed on our ability to effectively manage product and process knowledge.  Read their article along with 10 other articles dedicated to the topic of knowledge management in the pharmaceutical industry.

Don’t miss ISPE’s recent Pharmaceutical Engineering E-supplement on Knowledge Management,  for the views of other international regulators, industry case studies, academic research and service providers relating to several aspects within the emerging area of knowledge management.

Whether you have begun your knowledge journey or are still considering how to embark on it, ISPE’s dedicated Pharmaceutical Engineering E-supplement on Knowledge Management is a must read for all industry professionals.