Quality/GMPs

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 from its facility in Ingelheim am Rhein, Germany.

USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.

The U.S. Pharmacopeial Convention is offering free online access to public standards to help ensure the quality of the herbal ingredients used in medicinal products.

FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies.

New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries.

EMA clarifies biosimilars guidelines.

Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

KR Karu from Sparta Systems spoke with BioPharm International about the importance of having an enterprise quality management system.

The author presents best practices for extractables and leachables.

Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.

FDA issues draft guidance to minimize medication errors.

Third compounding pharmacy recalls products due to FDA inspection.

FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.

FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls.

FDA's FY 2014 budget includes more than $10 million above the 2012 budget for inspections of products and ingredients manufactured in China.

FDA inspections of compounding pharmacies result in FDA-483 citations.

Prefilled-syringe line features automation and novel disinfection techniques.

Reduced carryover risk and close attention to particulate control result in greater patient safety through the use of single-use systems.

The authors suggest techniques for mitigating risk and securing the supply chain for single-use components used in biopharmaceutical manufacturing.

Have FDA initiatives improved manufacturing quality?

Latin America's diverse growing market seeks regulatory harmonization.

Opioid abuse generates calls for efforts to curb distribution.

EU authorities are stepping up their efforts to incorporate QbD principles.