Quality Systems

ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.

FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.

EMA has published a new guidance template for the qualified person’s declaration concerning GMP compliance of API manufacture. The QP declaration template provides the basis for demonstrating compliance of the API manufacture with GMP requirements and ensures that the manufacturer has sufficient knowledge on the supply chain.

Draft guidance from FDA includes information essential for the completion of ANDA applications.

USP and USAID give prequalification status to Capreomycin, an anti-tuberculosis injectable.

Despite GMP deficiencies, EMA reinstates GMP certificate for Ranbaxy's Toansa facility, citing no threat to public health.

EMA publishes revised guideline on the acceptability of names for drugs.

FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

The Rx360 pharmaceutical supply chain consortium celebrated its first five years with an anniversary conference the week of June 5, 2014 in Washington, D.C. The conference featured key FDA officials and industry leaders.

Kurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics discusses interactive response technologies and the management of pooled supplies.

Alexion initiates a voluntary nationwide recall of certain lots of soliris (eculizumab) concentrated solution for intravenous infusion because of visible particulate matter in a single lot.

FDA launches openFDA to provide easy access to FDA public data.

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.