Quality Systems

The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.

Progress is being made, but work remains to be done. Brian Daleiden, vice president of marketing at TraceLink, discusses the state of the industry, as companies attempt to meet complex, and changing, global requirements.

A federal judge entered an order of permanent injunction against Paul W. Franck, the owner and operator of several compounding pharmacies in Florida.

The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.

As the pharmaceutical industry moves toward continuous manufacturing, new documents are needed to provide flexible guidance that meets the new process requirements.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

Revisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.

Application for Sirdupla Uniformity of Delivered Dose Methodology

With deadlines only a few years away, some companies have not started serialization programs, while others are taking a tactical, short-term approach, losing out on potential business benefits.

In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.

The author looks at EUCAST’s role in tackling the spread of antimicrobial resistance, by creating definitions for a global consensus.

The agency found no differences in risk of pneumonia for different products.

The agency extends the indication of the drug in combination with bendamustine.

The agency recommends the approval of Zavicefta to treat infections caused by resistant bacteria.

Platinum Press provides serialization-ready printed materials to apply final track-and-trace data onto packaged pharmaceutical products.

Immuno-oncology drugs are demonstrating patient benefits, but growing resistance to the high cost has implications for patients, market access, and manufacturers.

The agency holds a workshop to strengthen collaboration with healthcare providers.

The company voluntarily recalls product due to particulate matter.

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

Instruments are introduced for elemental impurity analysis and materials identification.

Highly potent or cytotoxic drugs require special handling

The guidance discusses the implementation of CMC postapproval changes through a comparability protocol.

PRAC said it has plans to review both canagliflozin and several direct-acting antivirals, after new study data showed potential risks associated with the drugs.

The agency published guidance on data integrity as it is relates to CGMP compliance.

FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.