Search results for " acceptance criteria"
Article
Establishing Acceptance Criteria for Analytical Methods
Clearly defined method acceptance criteria that evaluate the goodness and fitness of an analytical method for its indended purpose are mandatory to correctly validate an analytical method and know its…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
…roach (grey parabolic curve) where bias and precision are interdependent compared to the traditional acceptance criteria (green rectangle) where accuracy and precision are treated separately.
T…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The design space represents all combinations of CPP set points for which the CQA meets acceptance criteria.
Overall, the design space developed from process characterization study models rep…
Article
Evaluating Design Margin, Edge of Failure and Process
…radation) can be processed and achieve all critical quality attributes (CQAs) and associated product acceptance criteria. Knowledge of product or process acceptance criterion (specification limits) i…
Article
Understanding Validation and Technical Transfer, Part 3
The product specification includes tests, analytical procedures, and acceptance criteria defining the product and establishes the set of criteria for demonstrating the product is acceptable for its in…
Article
Essentials in Establishing and Using Design Space
…high amounts of degradation) and achieve all critical quality attributes (CQAs), product and process acceptance criteria, and specifications. Knowledge of product or process acceptance criterion (spe…
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Regulatory Challenges in the QbD Paradigm
In any case, all eCPs must provide adequate quality risk management, and predefined requirements and acceptance criteria in enough detail to allow for subsequent reduced reporting requirements followi…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
… a given range of a process parameter (referred to as proven acceptable range or PAR), the CQAs meet acceptance criteria. While univariate experiments can provide some limited knowledge, a compilatio…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
After all, data are compared to acceptance criteria in countless decisions regarding clinical trials, experimental studies, qualifications, and product release. Either the acceptance criteria are met,…
Article
Impurity Testing of Biologic Drug Products
Validation for an investigational new drug or at Phase I level would have the more basic requirements, with fewer tests to be executed, a smaller number of repetitions, and wider acceptance criteria. …