ARTICLES BY JIM MORRIS
Applying The Johari Window To Manage Pharmaceutical Supply Chain Risk
The recalls of generic versions of the drug valsartan and related products losartan and irbesartan due to high levels of nitrosamine impurities have once again put the spotlight on sourcing strategies and the globalization of the pharmaceutical supply chain. Learn how the Johari Window model can help minimize risk and shrink the unknown risks inherent in any complex manufacturing supply chain.
6 Recommendations For Managing Complexity In Pharmaceutical Operations
There's a tendency in biopharma operations to make things more complex than they need to be. More content in an SOP, additional signatures, new forms, and control loops don't necessarily equate to better.
Beyond Human Error: Are Blunt- Or Sharp-End Decisions More Important In The Life Sciences?
Decisions made upstream in the supply chain can have enormous repercussions downstream at the bedside or in the home, where medications are administered. How do we guarantee that the big and seemingly small decisions being made with each batch manufactured will be the “right” ones when there is so much inherent variability around us?
The Top 3 Forms Of Operational Overcomplexity In Pharma Manufacturing — And How To Simplify Them
We like simplicity. Yet in pharmaceutical operations we have become very good at making things more complex than they need to be. This article illustrates a few areas where companies tend to make matters worse and highlights areas where both industry and regulatory agency leaders should push back and focus on simplification.
Auditor Evaluations: A GMP Auditing Best Practice
Given the importance of auditor performance, do managers responsible for audit programs solicit and provide feedback on auditors? Very rarely.