Quality Systems

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

Concern by environmentalists, regulators and manufacturers rises over the environmental impact of pharmaceuticals.

Statistical analysis shows how much testing is needed to deliver a reliable estimate result.

In legacy facilities and as buildings age, ensuring cGMP compliance can become complex. A review of a facility's gowning operations can bring insight into the current state of cGMP compliance. The author presents characteristics to look for and questions to ask.

The European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.

An established drug-manufacturing base with quality and safety issues, and patent protection and price capping concerns complicate efforts to do business in India.

A drug sponsor?s responsibility does not end when a task is outsourced.

John Hopkins and UCSF-Stanford join FDA?s Centers of Excellence in Regulatory Science and Innovation.

FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.

The EDQM grants Gnosis a CEP for teicoplanin, a true fermentation glycopeptide antibiotic produced by actinoplanes teichomyceticus strains.

Pfizer will submit a NDA with FDA for palbociclib, a treatment for locally advanced or metastatic breast cancer.

FDA issues complete response letter for Novartis' RLX030 for acute heart failure.

EMA opens registration for it's sixth annual workshop on pediatric drug research and development.

FDA and EMA release a draft joint proposal on the development of new drugs to treat Gaucher disease in children.

EMA and ECHA sign agreement to share information and work together on risk assessments.

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

FDA clarifies stability data recommendations for abbreviated new drug applications.

MG America's ACE-BT300 Coding and Verification Unit provides track-and-trace capabilities for bottles.

Life-sciences companies can get a jump on potential quality problems by looking at the leading indicators hiding in the document management process further upstream.

FDA releases draft guidance on the development of drugs to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia.

New identifiers and tracking requirements aim to block illegitimate products.

Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.

The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.

Common challenges and key considerations when developing a freeze-drying cycle for protein pharmaceuticals.

Siegfried Schmitt, principal consultant at PAREXEL, discusses the importance of quality-technical agreements.