Quality/GMPs

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.

The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.

The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.

FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.

FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.

Cultural and language discrepancies during an audit can be resolved using what many call a “playbook,” says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

Using a QbD approach from early-stage development through commercialization can ensure that upstream processes are efficient and reliable.

FDA and USP take sides in debate on biologic drug standards.

Real-time monitoring of product- and process-related impurities remains a challenge.

FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.

In this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.

Three months following his departure from FDA, former commissioner Scott Gottlieb joins Pfizer’s board of directors.

The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.

The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.

Congress is weighing in on drug pricing with a range of measures that differ in style and substance.

Simple components help maintain physical integrity throughout a bioprocess setup, and single-use components play a role in ensuring a closed system for aseptic processing.

Single-use systems offer a solution to the challenges inherent in buffer preparation, which can be the cause of bottlenecking in bioprocessing.

Vida International received an FDA warning letter after an inspection found quality control violations.

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.

Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.

Gene therapy development company, bluebird bio, has revealed that the European Commission has granted conditional marketing authorization for Zynteglo.

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.

CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.

As SUS become prevalent in the biologics industry, the question of safety becomes increasingly important.

FDA’s annual manufacturing report card shows more quality compliance is needed.

A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.