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understanding of the topics process analyzers/spec-troscopy, data management, process equipment, and
control systems. Especially the software interfaces
between PAT and PLC of the unit operation must
be specified, based on thorough understanding of
both software environments. The customer must be
aware of this and be sure to understand the different
requirements, to then coordinate between the vendors
to ensure data exchange between NIR system, model
engine and unit operation.
Although the previous example considers a gradual
implementation, the correct approach towards PAT
should be much more strategic. That is, a long-term
PAT strategy including roadmap must be developed
for the company. This strategy must consider factors
such as existing knowledge, product portfolio, product
innovation, and company size. Only then, a lasting
PAT roadmap can be derived, avoiding disappoint-
ment and overspending. Critical decisions in this PAT
• Unit operations and product candidates for imple-
• Integration level for process control
• PAT data infrastructure (standalone vs. central-
• Chemometric modeling (make or buy)
• Maintenance of PAT models
• Reporting of CQAs and CPPs (centralized vs.
• Regulatory considerations and cGMP/GAMP
Introducing PAT as an integrated approach towards
improved quality and process control is a complex and
difficult project. While the analyzer equipment is proven and available on the market, the chemometric modeling and software integration within a regulated manufacturing environment represents the major challenge.
Furthermore, the establishment of necessary resources,
knowledge, and qualification must be accounted for.
The implementation of a PAT strategy and roadmap
ensures that the project execution does not surprise
the team and stakeholders. And with a dedicated
strategy the PAT architecture is prepared from the
beginning to fit the future needs and plans for the
company. Most importantly, the implementation team
will be sure to have the necessary skill sets to tackle
the actual introduction.
In conclusion, pharmaceutical companies are suggested to seek for professional advisory on the technologies and requirements, allowing them to successfully
introduce PAT and eventually build up internal working
groups, which suit their business case and capabilities.
OfficeofMedicalProductsand Tobacco/CDER/ ucm088828.htm
Figure 6: PAT data infrastructure with integration into process control logic