Quality Control/Quality Assurance

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

The issues cites the Taiwan facility with violations of current good manufacturing practice regulations.

FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.

The agency cited a Memphis drug compounder for misbranded drugs and a lack of appropriate sterile processes.

FDA cited a Las Vegas compounding pharmacy for sterility violations.

The agency cited KO DA Pharmaceutical Co. with cGMP violations.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on data integrity.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.

The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.

The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk mitigation.

The agency now allows production of water for injection by non-distillation technologies.

The agency cited Emcure Pharmaceuticals with CGMP violations.

Policy makers debate strategies for promoting access to less costly medicines.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.

The directorate is looking for experts to join the European Pharmacopoeia network.

FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.

CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.