Bill Swichtenberg just filed the following minireport on today's program
The one thing Im learning here in
Baltimore at IFPAC is that PAT has a lot of buzzwords. The Organizational Transformations and PAT session may have used them all. The session looked at some of these changes at different big pharmaceutical companies.
Jay Jetts talk Right First Time and Operational Excellence focused on Pfizers approach of reducing process variability and consequently improving process capability. Pfizer keys on the 5-15% of the process that is value-added. According to Jett (a black belt), Pfizer is committed to Six Sigma and the projects fall into one of four methods. Everyone at Pfizer is trained in method 1 which is the DMAIC method. Method 2 is run by Green Belts (5% of the company). Method 3 eliminates variations and is run by the Black Belts (1%). The master black belts (about 11 people) are trainers and look at method 4 which is finding efficiencies (QbD). Pfizer looks at processes first then looks to improve efficiency. If not, you just make junk faster, says Jett.
John Levins explained how Wyeth is building an integrated PAT program to transform their manufacturing practices across the Consumer Healthcare Division. Started in 2003, John virtually was the PAT program that looked at developing process analyzers for measuring critical quality attributes when it began.The start of this program was looking for simple change control. Critical quality attributes dont depend on scale, said Levins.
Once this capability and methodology was in place, a leadership team was formed (in 2005) to guide the PAT initiative into a full systems approach. According to Levins, PAT requires an organizational change. Three guidelines he advocated were an initial strategy by upper management, a central manufacturing leader (with resources for PAT assigned by plant leadership and finally technical strategy set and then challenged by a leader.
At Merck, John Higgins described how they are using a technical approach to integrating PAT supported by a business justification. According to Higgins, there are many enablers needed to make PAT successful. These include an internal/external regulatory framework, a business case for PAT, technological development, communication and training and statistical data analysis. The implementation and on-going performance of PAT methods often creates unforeseen challenges, says Higgins. These challenges are not realized until real manufacturing takes place.
When deciding on PAT projects, Higgins said that Merck looks at five considerations. These include a strategic alignment with business priorities, financial analysis, resource requirements, the probability of success and regulatory implications/cGMPs.
According to this panel, PAT has grown beyond the why and what stage. Companies are now, more importantly, looking at the how and the institutionalization of the process.
While PAT always seems to focus on NIR equipment, it was refreshing to hear a speech on PAT that dealt with passive acoustics. Whats this you ask, it was piezoelectric sensors that recorded sound differences in a granulation monitoring application. Albert Alexander of AstraZeneca explained how he used this approach to correlate acoustic data to granulation. First this approach was used for dried granulations from different experiments (varying water amount, water rate, massing time) and related granule characteristics (size, porosity) to acoustic changes. This was used to assess the relationship between acoustic evolution and specific granulation mechanisms. The second part of the approach classified the data into clusters to determine endpoints. Granulations were then run using these endpoints with the resulting granules compared for similarity. It was found that this approach correlates well with wet mass characteristics.