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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.
October 03, 2016
FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.
he guidance addresses the good manufacturing practice for managing quality in APIs.
Pharmaceutical manufacturers and business partners are studying how Advanced Digital Ledger Technology might solve supply chain and other data transfer problems.
The company is voluntarily recalling all unexpired lots of 50-mm, 0.2-micron filters.
EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.
October 02, 2016
Efforts to accelerate drug development will alter fee structure and require ready production sites.
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
A number of organizations have analyzed and estimated the size of pharma’s counterfeit and diversion problem.
As criminals duplicate the latest overt security technologies, pharmaceutical manufacturers are evaluating covert and layered approaches to fight counterfeiting, theft, and illegal product diversion.
Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.