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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.
July 22, 2016
The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.
The agency has recommended granting marketing authorization in the EU for Truvada.
The company announced that its facilities and laboratories have completed FDA pre-qualification inspection.
The company manufactures biological drug products and intermediates for the allergy vaccine market.
The company voluntarily recalls all lots of lyophilized HCG and sermorelin.
July 21, 2016
GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.
Generic versions of AstraZeneca’s blockbuster Crestor will hit the US market after a federal judge refused to issue a restraining order blocking the approval of rosuvastatin ANDAs.
July 20, 2016
The committee voted unanimously in favor of approving the drug, but the majority supported implementing additional risk management.
July 19, 2016
The company is voluntarily recalling a docusate sodium solution distributed by Rugby Laboratories due to risk of contamination.
FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.