Internal quality control is an integral process of laboratory testing. A clinical laboratory's coagulation quality control (QC) program is a critical component of its quality assessment program. The ...
Cannabis testing laboratories play a pivotal role in the multidimensional cannabis industry. Production companies to the consumers, whole cannabis community rely on the analytical results produced by ...
The Federal Circuit recently affirmed that a generic pharmaceutical company’s use of post-approval quality control testing was not “making” under 35 U.S.C. § 271(g). See Momenta Pharmaceuticals, Inc.
On April 21, The U.S. Food and Drug Administration (FDA) suspended its quality control program for testing milk and other diary products. The FDA has also suspended existing and developing programs ...
Like traditional biologics, cell and gene therapies (CGTs) must meet safety and efficacy standards before they can be administered to human patients. But the manufacturing processes used for this new ...
Microbial quality control testing is fundamental to pharmaceutical product safety, yet traditional approaches demand extensive resources, specialized expertise and considerable time investment.
Quality assurance/quality control of manufacturing processes often involve a large amount of mechanical testing—tensile and flex primarily. These tests are well defined by standards and demand a high ...