Quality Systems

FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.

Analytical procedures and method validation should be developed with a structured and rigorous approach.

The agency cites deviations from CGMPs for the manufacture of APIs at the company?s Gujarat, India plant.

USP releases compendium of quality standards for compounded medicines.

Threshold Pharmaceuticals' anticancer drug TH-302 receives FDA Fast Track designation.

The European Medicines Agency responds to the European Ombudsman?s letter regarding redacted documents.

FDA releases guidance specifying its preferred unique facility identifier system.

An FDA warning letter to Hikma Pharmaceuticals cites violations of CGMP at its plant in Portugal that manufactures finished drugs.

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

Resolving the problem will require more communication between the industry and regulatory bodies.

The parenteral manufacturing industry is taking action to address particulate contamination issues.

The authors explore and define common industry approaches and practices when applying GMPs in early development.

The authors take a look at some of the recent developments in the German pharmaceutical market.

Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.

Supply chain security and quality group Rx-360 driven by patient safety.

The European Union takes the lead in a global pilot project on the marketing approval of generic medicines, highlighting the challenges of achieving consensus among different nations.

The Brazilian economy is being impacted by internal and external factors, and forecast figures are being quickly revised downwards.

Gerresheimer, a company with expertise in pharmaceutical and medical technology, announced that it is applying an integrated mold qualification and validation concept for a fast and cost-efficient time-to-market. The company notes that this approach provides process windows for reliable large-scale production and offers options for different deployment scenarios and qualification levels.

A customer complaint prompts the recall of a lot of anticoagulants from a plant in Puerto Rico.

Contract Packaging Resources issued a voluntary recall of naproxen sodium tablets because some cartons contain bottles of ibuprofen.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

A selection of articles and news about quality metrics.

After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), has administration approval for organizational changes to bolster programs and policies to ensure drug quality.

Hospira voluntary recalls certain lots of several LifeCare products due to potential for leakage.

Iclusig?s original indication will remain unchanged after a thorough examination of its safety information by EMA.