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Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

The US Food and Drug Administration has opened the FDA Electronic Submissions Gateway (ESG) to receive and process regulatory submissions to the Center For Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health.

FDA Introduces Electronic Submissions Gateway

How does the latest agency task force report resonate for pharma and radio-frequency identification?

FDA Is Taking Baby Steps Toward an RFID Mandate

Quality must not only be part of the process, it must be a component from the start.

Outsourcing Toolkits from the PharmTech Annual Event

Risk assessment and management applies to technical matters as well as to interactions between organizations.

Defining and Managing Risk for Projects with a Contract Manufacturing Organization

The UK Medicines and Healthcare Products Regulatory Agency (MHRA, London) has reissued its recall of a specific batch of counterfeit ?Lipitor? 20-mg tablets. MHRA, in conjunction with Pfizer (New York City, NY), first issued the recall of batch number 004405K1 in July 2005. The new recall is in response to the discovery of more packages of the counterfeit drug in the United Kingdom.

MHRA Renews Recall of Counterfeit Lipitor

A group of researchers from Georgia Institute of Technology (Atlanta, GA) are using high-throughput ionization techniques to identify and measure the ingredients in counterfeit drugs.

Georgia Tech Researchers Develop Anticounterfeiting Analytical Chemistry Techniques

The US Food and Drug Administration?s Counterfeit Drug Task Force (Rockville, MD, www.fda.gov) is recommending regulatory actions and the implementation of new technologies for reducing the risk of counterfeit drugs entering the United States. The group has followed up on its original 2004 report, in which it outlined the framework for protecting the public from counterfeit medicines, and an updated 2005 report with a third document encouraging electronic pedigrees, improved traceability in the drug supply chain, and the adoption of radio-frequency identification (RFID) tools.

FDA to Strengthen Fight Against Counterfeit Drug Products

Thermal effusivity and power consumption may help predict granulation end point in high-shear granulators. In this study, power consumption was monitored and compared with percent relative standard deviation (RSD) on thermal effusivity measured at-line. Lactose monohydrate, microcrystalline cellulose, and magnesium oxide were granulated, and the effect of load size on granule growth in a fixed-volume granulator was evaluated using three load levels. Load size, liquid addition rate, and impeller speed were measured, and the correlation among RSD on effusivity, power consumption, mean granule specific surface area, and granule compressibility index were determined. 

Thermal Effusivity and Power Consumption as PAT Tools for Monitoring Granulation End Point

Predictable outcomes lead to greater manufacturing efficiency and speed time to value.

Better Process Understanding Improves Quality, Lowers Risk

In the face of spiralling R&D costs, currently estimated at $800 million to produce a new drug, the discovery industry is constantly searching for ways to keep expenditure low, increase productivity and meet ever-stricter guidelines imposed by regulatory bodies.

Data and Artificial Intelligence