Quality Control/Quality Assurance

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.

The bio/pharmaceutical industry will face increased scrutiny of product quality and cost drivers.

The United States Pharmacopeial Convention announced the recipients of the 2015–2016 Global Fellowship Awards.

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.

New program emphasizes quality, risk, and global collaboration.

Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.

USP responds to FDA's draft guidance on the naming of biological products.

The PDA report discusses qualification and operational handling of passive thermal protection systems.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

US Compounding, Inc. issues voluntary recall of all sterile products.

Manufacturers challenge details in new policies designed to promote access to important therapies.

The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.

UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

The rapid microbiological growth-based method represents an alternative for the quantification of contaminants in filterable products.