Quality Systems

Increased pharmaceutical trade creates new challenges for regulatory oversight.

Depomed, Inc. announced that FDA has accepted for filing a new drug application (NDA) from Mallinckrodt for MNK-795.

The precautionary recall follows manufacturing deficiencies identified at the site in India.

Europe prepares for inclusion of Croatia in EMA activities.

Programs assist in the fast track of drugs for serious conditions.

Brazil offers opportunities and challenges for global pharmaceutical companies.

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

David Elder, vice-president, technical at PAREXEL, discusses the best way to productively participate in a regulatory meeting with FDA.

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.

USP focuses on building worldwide partnerships in standards-setting activities.

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.

Greater sophistication in 3D X-ray imaging technology raises its utility for QA/QC in manufacturing.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

Cocrystals can enable the formulation of solid dosage drugs, but the FDA's final guidelines have left concerns about how their use could impact development timelines, the drug product manufacturing process, and the intellectual property position of products containing cocrystals.

The Alliance for Fair Trade with India is seeking action to resolve discriminatory trade practices and improved protection of intellectual property rights.

ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages.

USP appoints regulatory experts to elemental impurities implementation advisory group.

EMA's revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.

FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico.

FDA Discovers Microbial Contamination in Compound Pharmacy Products

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

The authors discuss three methods for identification of out-of-trend (OOT) results and further compare the z-score method and the tolerance interval in OOT analysis for stability studies.

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.

A unique demographic and payer mix make ASEAN an increasingly attractive region.

Siegfried Schmitt discusses the European Commission's (EC) guidelines on Good Distribution Practice of Medicinal Products for Human Use

The Taiwanese government engages in regulatory science in a move to boost its pharmaceutical sector.

An overview of the latest regulatory developments for malaria drugs, biosimilars, and global standards.

FDA addresses shortages of drugs needed to treat premature infants and patients unable to eat or drink by mouth.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.