Quality Control/Quality Assurance

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.

In late 2014, standards organizations continued to work towards harmonization and securing drug safety.

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

USP releases compendium of quality standards for compounded medicines.

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

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

FDA report details risk mitigation projects.

USP expresses its support for a consensus-based global approach to the naming of biologics.

FDA demands accurate manufacturing and test information to ensure product quality.

A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.

The BioPhorum Operations Group has published a resource to help the biopharmaceutical industry deliver a consistent approach to continued process verification.

Quantitative Mycoplasma DNA Offers Quality Control

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

Supplier Audit Program Marks Progress

Achieving excellence in human performance is an achievable system of cultivating and sustaining exceptional levels of performance.

Challenges in Securing the Biopharma Supply Chain

ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.