Search results for " acceptance criteria"
Article
Essentials in Quality Risk Management
…gh CQA generation to analytical method selection, unit operation characterization, specification and acceptance criteria limit generation, critical process parameters and control selection, and final…
Article
PDA's Technical Report for Biotech Cleaning Validation
…so that any samples taken during qualification protocols or during routine maintenance will pass the acceptance criteria with a good margin of safety (e.g., a robust cleaning process is designed). Th…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
…d be performed as part of the design stage to ensure that testing of the surface can meet predefined acceptance criteria. Surface sampling should define the swab or wipe used, surface location sample…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
As part of this approach, a platform glucose method that utilizes a linear standard curve was validated using alternative cell-culture media, and all established acceptance criteria were met. The assa…
Article
Robust Optimization, Simulation, and Effective Design Space
Typical acceptance criteria confirm the small- or at-scale measurements are within the 99% quantile interval from the simulated results. If there is a detected shift between the small-scale and at-sca…
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Ensuring the Quality of Biologicals
These individual monographs provide analytical procedures and acceptance criteria to allow demonstration that a substance or product meets the required quality standards. The monographs are based on l…
Article
Quality by design for biotechnology products—part 1
Guidance for industry: Q6B specifications: Test procedures and acceptance criteria for biotechnological/biological products. Rockville, MD; 1999 Aug.
21. Submission of Quality Information for Biot…
Article
Understanding Validation and Technical Transfer, Part I
…that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria” (9).
Process validation
The concepts presented in the definitions of…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Changes in cell-culture process scale and/or manufacturing site may not require re-testing of cells at the limit for in vitro cell age, provided the available data meet the predetermined acceptance cr…
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Best Practices in Qualification of Single-Use Systems
The supplier’s release criteria and end-user’s receiving acceptance criteria should be aligned with each other. These include, but are not limited to, packaging integrity, appearance/identity, contami…