Press Room

Hovione speakers at the QRM Summit

Start
Thursday, May 11, 2017 - 08:30
End
Thursday, May 11, 2017 - 15:30
Location: Lisbon, Portugal

HOVIONE PRESENTATIONS

Guy Villax, CEO
8:30 - 9:15 am

Guy Villax will be the keynote speaker at the second day of the Quality Risk Management Summit. Under the Supply Chain Integrity block, Guy's talk will address the topic Do patients want capsules full of compliance, or full of quality? Why Quality culture wins every time.

 

Joerg Gampfer, Senior Director Quality
11:30 - 12:00

The whole is more than the sum of the pieces - building strategy on Knowledge and Risk Management

 

Luisa Paulo, GMP Compliance Director and ICH Q12 Team Member
14:00 - 15:00

QRM Enabled Post-Approval Changes & Lifecycle Management within ICHQ12

 

You might be also interested in:

 

Quality Culture Wins Over Compliance

Pharma's Almanac, June 2016

Why Dr. Hamburg Needs Her Dean’s List

Guy Villax Letter, June 2014

Also in the Press Room

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

Article

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024