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QRM Process

Quality risk management (QRM) is a systematic process that assesses risk to the quality of a drug product. Here you will find broad pieces about strategic operational philosophies or risk management plans geared towards controlling risk or regulating quality in manufacturing.

Articles

Optimizing supplier quality management

Adopting a risk-based model for inspections will flag suppliers who aren’t up to par

Engineering Angles: Optimizing the facility design phase

Early planning will ensure pharma facilities meet requirements

Maintaining compliance beyond the pandemic

Investing in employee readiness will be crucial to present and future success

Quality woes thrust Emergent back in the spotlight

Earlier this week, new reports revealed that a production mistake at an Emergent BioSolutions facility contracted by Johnson & Johnson to make its COVID-19 vaccines lead to...

Redefining quality with analytical monitoring

How advances in biopharmaceutical characterization technologies are improving drug quality

News

FDA warns of blood pressure med shortage

Tris Pharma recalls infant ibuprofen

India regulators to re-inspect 147 drug plants

FDA accuses manufacturer of ignoring quality control tests

Dr. Reddy's Hit with FDA Warning for 3 Key Plants

Drug Makers Appeal German Drug Suspensions

Compressed air quality

Particle analysis methods and ISO 8573 Standard updates

Pharma’s door to QRM success

The maturation of the cloud makes adoption of proactive quality risk management possible.

Modernizing manufacturing through a connected shop floor

Eliminating siloed systems in favor of streamlined applications allows for greater agility and stronger collaboration, enabling pharma to meet the new quality management demands...

Compressed air — the overlooked element of cleanroom specifications

How applying cleanroom standards to compressed air systems can provide clarity and reliability

The Future of Quality Control

Digital and automation technologies have created opportunities for change in pharma QC laboratories

Pharma’s Reputational Tornado Zone

Companies that want to differentiate themselves need to adopt new operational and risk management defenses

3 Signs Employee Turnover is Impacting Your Operational Efficiency

Signs that CRO turnover is impacting your productivity, speed to market and bottom line.

Transforming Bioburden Risk with Digital Asset Intelligence

Asset intelligence gives cGMP manufacturers a new way to harness the information they need to prove manufacturing compliance

Toward Zero Defects: Using Analytics to Reshape Quality

Advanced analytical techniques can help companies identify and eliminate hidden sources of quality problems

Simplifying Flow and Level Instrument Verification

Automatic verification can minimize the need for expensive instrument calibrations