ABSTRACT
Conventional pharmaceutical manufacturing practices
have low manufacturing efficiencies and capacity util-
ization, high scrap and reject levels, and therefore a high
cost of quality. PATis a toolkit used to increase operational
efficiencies, capacity utilization and process under-
standing, while decreasing operating expenses and
ensuring that quality is built into the product. Multiple
benefits associated with PAT implementation have been
identified, but these benefits are not without drawbacks
such as limited employee technical knowledge and sub-
optimal return on investment. The benefits and challenges
of PAT are reviewed in this chapter, together with a
discussion of the conventional pharmaceutical manufac-
turing paradigm, PAT principles and tools, PAT guidance
development to date, and PAT validation approaches.
