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This chapter will discuss strategies and tools for quality improvement—including failure modes and effects analysis, Plan-Do-Study-Act, Six Sigma, Lean, and root-cause analysis—that have been used to improve the quality and safety of health care.
30 Ιαν 2024 · Quality by Design (QBD) represents a transformative approach to pharmaceutical development, emphasizing a systematic and science-driven methodology to ensure consistent product quality....
Guiding principles, such as understanding systems and processes of care, appreciating the power of variability, and using data to drive change, can support the development of successful quality improvement initiatives.
9 Ιουν 2021 · For pharmaceutical and biopharma companies, adopting a Quality by Design (QbD) approach to process development makes good business sense. In addition to creating more robust formulas and well-documented processes, following a QbD approach can help ease regulatory compliance and ensure a stable process for long-term production optimization.
“Manufacturing process development should include, at a minimum, the following elements: Identifying potential CQAs associated with the drug substance [...]” “Applications should include the following minimal element [...]: safety and efficacy.
31 Μαΐ 2022 · The holistic QbD approach for formulation development (i.e., FbD) is based on the determination of five basic elements which are quality target product profile (QTPP), critical quality attributes, critical formulation attributes, critical process parameters, an apt DoE-led design, and control space.
1 Ιαν 2019 · Quality by design (QbD)-based product development involves the following elements: (a) identification of quality target product profiles (QTPPs) followed by critical quality attributes (CQAs) for various parenteral products, (b) process design and identification of critical process parameters (CPPs), (c) design space, and (d) control strategy ...
