Quality Systems

Articles

The author proposes a quality management system that uses the power of executive management to promote a positive quality culture.

A Next Generation of Quality Management

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

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

Parenterals, Particulates, and Quality by Design

A selection of articles and news about quality metrics.

Quality Metrics

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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.

FDA Reorganization to Promote Drug Quality

The European Medicines Agency releases highlights from its Pharmacovigilance Risk Assessment Committee safety review meeting in October.

EMA Releases Pharmacovigilance Meeting Highlights

We?ve just opened new pharmaceutical laboratories! Our experienced scientists offer independent chemical and microbiological quality control testing of APIs, raw materials, finished products and medical devices in compliance with cGMP

Pharmaceutical Quality Control Testing

FDA report details risk mitigation projects.

FDA Releases REMS Report

PDA surveys are designed to evaluate quality metrics practices at member organizations.

PDA Initiates Quality Culture Survey

Cubist Pharmaceuticals voluntarily recalls certain lots of CUBICIN 500 mg in 10 mL single-use vials because of the presence of particulate matter.

Cubist Pharmaceuticals Recalls CUBICIN

Biopharma manufacturers must reduce the risk in their complex supply chains

Quality Assurance/Quality Control