By Christine Park, Quality Architech
In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn't changed the 21 Code of Federal Regulations Parts 210 and/or 211 regulations, they have published industry guidance, the Quality Systems Approach to Pharmaceutical CGMP Regulations.
Swabians are regarded as being genuine tinkerers. Particularly so when it comes to mechanical engineering. Nowhere else in Europe are so many patents applied for in this industry. And nowhere in Germany are so many high-tech companies located away from the economic centers.
By Sean Tracy, Spraying Systems Co. Purchasing a new fluid bed system isn't easy. Fluid bed systems are expensive, complex, and require a great deal of careful consideration and research before buying. Ordering a machine that can't meet your process requirements could end up costing much more than anticipated, and there's no single system available that will suit everyone's needs. So, where should you start?
By D.I. Duncan, Lighthouse Instruments The use of coated stoppers for sealing product vials containing high-potency/high-concentration biotech drug product has increased during the past few years. Stoppers provide a barrier between the rubber stopper and the drug formulation.
By Anne M. Roush, 3M Drug Delivery Systems In the face of a significant patent cliff, many companies in the pharmaceutical industry are seeking new ways to protect their brands as long as possible, and reformulation presents one of the most obvious ways to do this.
The challenge to managing trials in Latin America lies in its highly regulated drug development environment. Independent regulatory bodies, local health ministries, their supporting agencies, and ethics committees mandated to ensure patient safety all currently slow down the regulatory approval process.
By Dr. John Carpenter, University Of Colorado, School Of Pharmacy Aggregation is one of the most problematic and challenging issues for the development of safe and effective therapeutic protein products. Aggregate amounts and types are critical quality issues. Moreover, even relatively low levels of aggregates potentially can cause immunogenicity in patients.