PAT in Tableting – What to Expect
The real-time release is an important step, if not the most important step, in continuous production, explained Lorenz Liesum, Head of PAT at Novartis, and the subject of specifications set out by the EMA in its guidelines ICH Q8, Q9 and Q10. One of his main conclusions: A PAT project is not completed right after validation, then it actually starts with automation, maintenance and using it at a daily basis
Project Efficiency as Answer for the Cost Challenge
The leap from continuous production over opex and onto project efficiency may seem large, but optimized planning of investment projects is also a building block on the way to making cost savings. Quality, time and costs are the points of the magic triangle which have occupied the mind of Dr Michael Atzor of Bayer. In the majority of cases it is not possible to satisfy all the demands, he said, as quality is the primary, and therefore non-negotiable, factor insisted upon by the companies. There are a few sticking points in the planning process. One is the time at which investment decisions are made. This normally happens in clinical phase 1 and therefore at a time when the development work is far from complete, as neither the formulation nor the production process has been finalized. Overlapping planning phases are virtually unavoidable in a pharmaceutical project, with process development and engineering work inevitably running in parallel. It is just as important, however, to define the rules of the game clearly, according to Atzor, who gave the delegates five dos and don'ts to take away with them and follow in order to at least pave the way for success.
* The author is senior editor of PROCESS E-Mail: firstname.lastname@example.org