Quality Assurance/Quality Control

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

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

Biopharma manufacturers must reduce the risk in their complex supply chains

Control charts that are properly constructed and maintained prevent false out-of-control signals and provide a useful method for monitoring a process.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to ensure data integrity.

Statistical analysis shows how much testing is needed to deliver a reliable estimate result.

A drug sponsor?s responsibility does not end when a task is outsourced.

Life-sciences companies can get a jump on potential quality problems by looking at the leading indicators hiding in the document management process further upstream.

Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.

This article takes a statistical look at the calibration requirements for a UV spectrometer.

PharmaCheck, a portable tool designed to detect poor-quality medicines, has been selected by Scientific American as one of the magazine?s World Changing Ideas of 2013.

An operational-excellence initiative increased collaboration between operations and quality personnel to address human-error-caused deviations.

Siegfried Schmitt of PAREXEL discusses regulation requirements for quality systems.

Recent FDA enforcement activity reveals issues with vial-filling, adequacy of QA/QC procedures, particulate matter in inhalation powders and injectables, and drug labeling.

How good is a reportable value?

Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party to be in keeping with quality risk-management principles.

Greater sophistication in 3D X-ray imaging technology raises its utility for QA/QC in manufacturing.

Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied.

The mysteries of rounding are exposed; strict, unbiased rounding can be applied.

Two methods to evaluate retest data following out-of-specification results.

Shortages and compounding disaster spur efforts to overhaul manufacturing oversight and stimulate industry improvements.

A change in terminology could emphasize patient protection.

Real-time experimentation may offer continuous process improvement.

Identifying and classifying rouge can help to determine CAPA.

Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls.

Experts share insights into analytical tools and techniques.

Applying current principals to traditional factorial designs.

Uniform dose formulation is key to meeting safety study requirements.

Are pharmaceutical manufacturers really serious about ensuring the quality of their medicines? And do they recognize that cutting corners on controls and quality management can be tremendously costly in the long run?

Understanding the differences between convenience, target, and self-selected samples.