Biomedical Engineering Reference
In-Depth Information
development environment only or if it has potential to be implemented in a manufactur-
ing environment. The executive governance board generally procures resources, both
capital and manpower, to ensure the success of the projects.
12.9.2 Organizational Management Challenges
There are many pitfalls to consider when setting up a PAT initiative within a biophar-
maceutical company. One scenario to be aware of is related to the interaction between the
PAT teams and the governance committee. Typically, PAT teams are interested in fixing
“real” problems on the manufacturing floor that resolve pain points related to high
process variability. PAT teams put large amounts of time and energy into developing
creative solutions and tools. When the tool is proposed to the governance committee and
determined to be nonvalue added by the committee, it can leave the team reluctant to
propose future solutions. Some of the answers can be found in the implementation of
tools found in Six Sigma teams that empower the team members to make the decision to
terminate a project or continue the project with agreed upon deliverables back to the
“sponsors” (governance committee).
Silo thinking between departmental lines is another pitfall to be aware of when
implementing PAT initiatives. Process developers tend to consider themselves as the
process owners, as they typically have the most experience with the process when it is
first introduced into the manufacturing environment. As a result, once the process has
been transferred into manufacturing, with enough runs, manufacturing personnel feel
that they now own the process. When one department proposes a PAT tool to add to the
process to fix a “problem,” it can beviewed as a threat in the other department. The process
developers may disagree that the process needs improvement because the development
was rigorous and shown to be scaleable and easily validated. The manufacturing
department may disagree that an additional tool is needed because they have the most
experience that allows them to operate the process without additional controls. Early
consensus building, from the conceptualization stage, is imperative to avoid falling into a
silo mentality. Early involvement of personnel from each group impacted by the proposed
change, allows the team to proceed forward and create the “buy-in” so that all parties agree
on the merit of a proposed project.
Another key area for a company to focus attention upon when considering PAT
implementations is to engage quality and regulatory departments early and often.
Encouragingly enough, a result from a 2004 PPAR (Pharmaceutical Process Analytics
Roundtable) survey noted that regulatory and QA “buy-in” were becoming less of a
barrier for introducing PAT technologies. In fact, it was noted that organizational
commitment to PAT as a process development effort was the main barrier cited in the
survey.
Regardless, regulatory and quality strategies must be developed to introduce the
tools into the manufacturing process and collect information, at scale, to determine if the
data provide the expected information needed to control the process. This is typically
managed through protocols that define the scope and duration of the evaluation and what
decision criteria will be involved to change the process to include the technology. As
Rathore and others point out, regulatory strategies need to be developed to address
