Roadmap for PAT identified key business drivers and implementation strategies for PAT within the pharmaceutical and biopharma industries with the goal of achieving successful PAT applications supporting Quality by Design and manufacturing excellence. Moderated by Joseph Famulare, Deputy Director, Office of Compliance, CDER/FDA and Janice Whitaker, Senior Vice President of Quality at GlaxoSmithKline, the panel took any and all questions from the audience.
Unfortunately, some of the same hurdles are standing in the way of PATs implementation, but that may be soon changing. There is a lot of movement with industry and regulators getting together but with regard to the total (pharma) industry, theres still a ways to go, says panelist Bruce Davis of AstraZeneca. From a global business standpoint, ICHQ10 is very important.
According to participants, the delivery of ICHQ10 will crystallize the benefits of PAT and provide some regulatory relief in the form of standardizing change movement and control. We in the U.S. have forums to discuss some of these issues with colleagues. There is a dialogue between FDA and industry, says Moheb Nasr, director, Office of New Drug Quality Assessment, FDA. ICH is forming a group to do this internationally.
Simply, how a company defines the process can be a hurdle to PAT implementation. If the process is not defined in a more flexible way, unwanted FDA supplements might be necessary. In addition, processes many times are not just test replacements. It is not always best to do the same tests with on-line measurements. For example, when making tablets, weight measurement might not be applicable to on-line analyzers. There is a level of control, but it is measured in a different way.
There is the conventional way of doing testing and development, but we are not stuck there, says Famulare. There is a return on investment (ROI) for doing PAT less wastage and downtime. It provides an opportunity from a business case scenario.
Some of the industrys old guard still needs to be convinced that PAT and QbD are the way to go. Lab samples are being replaced by on-line analyzers. Design of experiments that took weeks to do in the past are now done much quicker. It is a different approach for an industry that is used to doing things certain ways. However, new people in the industry dont have these same apprehensions. It is now a matter of convincing management.
Regulations
What does the FDA want in regard to QbD and PAT? According to Nasr, there is the perception that FDA wants industry to implement these initiatives on such a large scale for all processes. This is wrong. It is useful to understand your processes. These initiatives are an opportunity to implement process control.
The key is these initiatives are science-based. According to an audience member, the FDA has given companies the chance to forget about the regulations and concentrate on the science.
Famulare said that ICHQ10 is actually knowledge management and a way to continually improve your process. As we develop better control methods and instrumentation, companies will be better able to adapt and recognize weak points in their processes.
AstraZenecas Bruce says that this science-based approach is necessary. We need to get back to talking about science. In this regard he advocates the need for more good case studies and people to help talk about them.
Panelist James Drennen from Duquesne University reiterates this point. This is a great time for discussing theory and sharing examples," he says. "We need to get rid of the fear of being in non-compliance.
Over the next couple of days at IFPAC, people will have the chance to share their stories. Pharmaceutical Manufacturing will relay some of these to you.
