By Garry B. Takle, PhD
Volume 9, Issue 2 (Winter 2010/2011)
Contract testing organizations (CTOs) offer considerable value by providing testing services and expertise that may not be available within organizations that are developing and producing biopharmaceuticals, from virtual companies to fully integrated international organizations. CTOs are constantly challenged by the breadth of services that are requested as well as the levels of regulatory compliance that are expected and the degree of oversight that various companies intend to impose. And knowing this variability of needs and expectations often results in a CTO trying to become “all things to all people” regarding assay tech transfer, validation, and qualification. For example, with the same type of sample from the same stage of product development, one company may expect its contracted testing to comply with 21 CFR Part 210 and 211 (good manufacturing practice [GMP]) while another may expect its testing to comply with 21 CFR Part 58 (good laboratory practice [GLP]) with different assay validation expectations for each approach…
Citation: Takle GB. Development, Verification, Validation and Qualification of QC Assays: A Contract Testing Lab Perspective. BioProcess J, 2011; 9(2): 44-48. https://dx.doi.org/10.12665/J92.Takle
Posted online February 9, 2011