Quality/GMPs

Unexpected problems can become opportunities to share knowledge and improve processes.

A quality-by-design approach that defines potential viral contaminants of source materials can be used to achieve viral clearance.

Demand for new therapies and vaccines spotlights production challenges.

FDA report details risk mitigation projects.

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

GS1 publishes a healthcare industry guideline describing how to implement GS1 standards to support requirements of the 2013 US Drug Supply Chain Security Act.

GPhA throws its support behind a bill to prohibit companies from using REMS practices to deter competition.

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

FDA releases draft guidance on electronic submission of lot distribution reports.

This article is the third and final in a series designed to offer leaders and managers at all levels in the industry a road map to excellence in human performance and human error prevention.

Chinese healthcare reforms may be a double-edged sword for foreign companies.

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

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.

Industry associations play a strong role in helping the pharmaceutical industry meet challenges.

Developing and maintaining a current master plan for cleaning in multi-product facilities are crucial.

Program review can help quality risk management live up to the promise of ICH Q9.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

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

Cubist Pharmaceuticals voluntarily recalls certain lots of CUBICIN 500 mg in 10 mL single-use vials because of the presence of particulate matter.

AbbVie announced that FDA and EMA have granted orphan drug status to its investigational anti-epidermal growth factor receptor antibody drug conjugat, ABT-414, for the treatment of glioblastoma multiforme.

EMA has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of a module on the quality requirements.

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

Part II of this three-part series presents a roadmap to human error prevention.

The regulatory filing marks the first step in the approval process toward making RTS,S available as an addition to existing tools currently recommended for malaria prevention.

Baxter Healthcare has initiated a nationwide recall of more than 20,000 containers of a pre-mixed beta blocker due to the presence of particulate matter.

FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.

The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

FDA draft guidances seek to maintain accurate drug information in new media.