Change Control
Time is Running Out: Are You Ready For Serialisation?
August 28 by Pharmaceuticals & Biotechnology EditorMedicinal products intended for human use have to be serialised in Europe by 2016/17. Serialisation is no longer a matter of “if”, or even “when”; it’s just a matter of...
When Change Management is about Big Pharma Disruptive Changes ….
August 16 by Cristina FalcãoWhat were the odds that the drug makers would roll the dice and have not only a financial mega hit but in Mergers & Acquisitions and Offshore-Production two “star is born “stories in a single show...
Change Control, You’d Better Have One!
June 14 by Cristina FalcãoWhile Change Control (CC) is applied to the entire chain of events in any pharma industry, from R&D to batch release, it is the core function of any pharmaceutical plant. “Even when a c...
Improving PAT Validation
December 24 by Andrea CharlesQualification of equipment and validation of analytical methods are critical components for the implementation of process analytical technology (PAT). Martin Warman, Scientific Fellow, Analytical De...