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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
December 02, 2017
New gene therapies and combination products require innovative regulatory approaches.
Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.
A QbD approach can address manufacturing complexities in transdermal patch manufacturing.
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.
December 01, 2017
In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.
November 30, 2017
Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.
November 27, 2017
Manufacturers and trading partners struggle to meet drug tracking requirements
The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.
The company is recalling product because of microbial contamination.
November 21, 2017
Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.