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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.
August 29, 2016
The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.
FDA issued a warning letter to the company for quality control violations.
The agency sent a warning letter to Cape Apothecary for adulterated drugs.
August 19, 2016
The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.
The company is voluntarily recalling one lot of Oxacillin for Injection, USP, 10 g.
August 18, 2016
Arbor Pharmaceuticals is voluntarily recalling Cetylev (acetylcysteine) effervescent tablets due to inadequate seal of the blister pack.
August 17, 2016
The Chinese facility was cited for data integrity violations.
The Group is focusing on standardizing data exchanges between the enterprise serialization management function and product packaging lines.
Nine public health organizations submitted a letter to US House and Senate committees citing concerns about Section 11 of the FDA and NIH Workforce Authorities Modernization Act.
Flawed testing and analysis and a failure to analyze the root cause of customer complaints were among the top problems noted in FDA's letter to the Florida-based transdermal drug manufacturer.