| Popis: |
Process analytical technology (PAT) is an umbrella term that covers a range of tools and is often cited as being an important component of other innovative initiatives, such as quality by design, real-time release, and continuous manufacturing. PAT has brought together different disciplines, which was presumably one of the intentions of the Food and Drug Administration guidance “PAT- A Framework for Innovative Pharmaceutical, Development, Manufacturing and Quality Assurance.” PAT has different connotations within different industries, companies, and health authorities. Each company selects tools, vendors, integration with hardware and software, and how (or if) to communicate to Health Authorities. Different approaches to PAT can be used to achieve the same objective and depend on company internal factors, which have led to diversity of approach across the industry. This chapter includes a description of general strategies by development phase as well as the primary drivers for deployment of PAT. |
