Quality/GMPs

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.

Quantitative Mycoplasma DNA Offers Quality Control

European Medicines Agency clarifies advanced-therapy medicinal products classification.

FDA releases guidance documents and rules on requirements for compounding human drug products.

Is there potential for growth in Brazil's phytotherapic drug market?

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.

With globalization, biopharmaceutical companies must establish strategies to minimize vulnerabilities in the raw-materials supply chain.

Challenges in Securing the Biopharma Supply Chain

GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.

FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

EDQM details the agency?s accomplishments in 2013.

FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

FDA issues guidance on the use of social media in regards to prescription drugs.