Quality Management System (QMS)

iSpeak Blog
ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). The pharmaceutical...
Guidance Docs
Health authorities and regulators are increasingly looking for much higher levels of traceability during the manufacture of parenteral medicines. The...
Online Exclusives
Knowledge management (KM) has been a recognized discipline for over 20 years in other industries, although within the biopharmaceutical industry, its discussion and formal implementation have been slow to gain momentum. The topic gained regulatory significance in 2008 when the ICH guidance document...
Technical
In this article, a new method for the analysis and comparison of dissolution profiles is proposed and illustrated with case studies. This useful strategy makes effective use of dissolution profile data by using all data in each profile to create two...
Training
Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each....