Pg# ICH Q5E • If a manufacturer can provide assurance of comparability through analytical studies alone, nonclinical or clinical studies with the post-change product are not warranted. • However, where the relationship between specific quality attributes and safety

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View popup. Table 1. Summary of the common internal quality control (IQC) rules used for a two-level IQC system 12. The normal impression of an assay is assumed to be Gaussian. Therefore, by defining the control limits by ±2 SD, 5% of IQC results will by definition be outside of the range.

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DOI 10.1515/cclm-2013-1090 Clin Chem Lab Med 2014; 52(7): 973–980 Koen Hens, Mario Berth, Dave Armbruster* and Sten Westgard Sigma metrics used to assess analytical quality of clinical chemistry

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A master cell bank is critical to therapeutic product development and supports not only clinical development and manufacturing but also the commercial supply phase for biologicals. From the master cell line, a working cell bank is produced to ensure high quality production and for scale up to manufacture. Successful cell banks include:

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2006/3/24 · Although spark testing is one of the most common methods for in-process vacuum testing, it has its drawbacks: high voltage can damage delicate proteins, while false positives are common. Even when the test runs successfully, it fails to provide a quantitative measure of the vacuum in the vial.