Quality Control/Quality Assurance

The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.

The agency streamlines risk and mitigation information.

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.

The directorate highlights achievements accomplished during the year of its 50th anniversary.

Will biosimilars share a compendial identity like generic drugs do?

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.

Industry and regulatory agencies continue to make progress in establishing quality metrics for the pharmaceutical industry.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.

More reliable operations would accelerate product development and prevent drug shortages.

USP announces an implementation date of Jan. 1, 2018 for General Chapters Elemental Impurities-Limits and Elemental Contaminants in Dietary Supplements.

A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.

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

A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.

Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.

The agency cites Apotex’s Bangalore facility with quality system failures.

The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

FDA releases a Q&A with the Drug Shortage team leader from the Center for Drug Evaluation and Research.

Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.

Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

Manufacturers are under pressure to develop pipelines, promote quality, and justify pricing.