Quality/GMPs

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FDA issues draft guidance to minimize medication errors.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.

The authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.

The New Jersey-licensed specialty pharmacy recalls magnesium sulfate products and halts all production operations.

INTERPOL and 29 of the world's largest pharmaceutical companies have joined forces in an initiative to battle counterfeit drugs.

This article examines the options to best match needs and spending for quality and regulatory leadership.

The authors present solutions based on a review of current service offerings and their audit experience.

As biopharmaceutical/pharmaceutical companies increase their development of biologic-based drugs, companies providing analytical instrumentation and laboratory testing goods and services are, in turn, offering improved tools for biologic characterization, biomanufacturing, and related testing.

Optimized freeze-drying cycles can offer scientific and business advantages.

Vaccine development is benefiting from manufacturing advances.

Aggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.

USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.