Newsletter | January 15, 2013

01.15.13 -- Guidance For Quality Systems Approach To cGMP Regulations

Pharmaceutical Online Newsletter
Departments:
Solid Dose
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Critical Environments
Packaging
Inspection
QA/QC
Featured Focus: QA/QC
Guidance For Quality Systems Approach To cGMP Regulations
Christine Park, Quality Architech 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.
Process Analytical Technology (PAT) Approach To Automated Pharmaceutical Container Closure Integrity Testing
Economics Of Feeding: Total Cost Approach To ROI
Know Your Software: Reduce The Risk Of An Unexpected Controls Malfunction And Process Downtime
Identify Contaminants For Fast Corrective Action
PureFeed Pharmaceutical Feeders
» Packaging
Wallet Packaging Trends For The Pharmaceutical Industry
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.
Bonfiglioli BLI Series Pharmaceutical Blister Leak-Testing Machine
Bosch Checkweigher: KWE 4000 Series
Veripac 410 Blister Leak-Tester Brochure
Unused Bosch Blister Packaging System
» Solid Dose
5 Tips For Finding The Right Fluid Bed System
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?
Xpert X-Ray Inspection System
IMA In Blister Packaging
Pharmaceutical Tablet And Tooling Microscope Inspection
» Inspection
Container Closure Considerations For Coated Stoppers
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.
Eriez X-Ray Inspection Systems
TVIS-EX3CD Tablet Visual Inspection System
Seal-Sensor Inspection Systems
» Liquid Dose
Rethink Transdermal
Christine Park, Quality Architech 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.
Used Cozzoli Liquid Vial Filling Line Model LFTP-10
» Logistics
Latin America Emerges As World Competitor For Global Trials Despite Tough Regulatory Environment
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.
XDx Uses FedEx Priority Alert To Deliver Accurate Results
When Failure Is Not An Option In The Supply Chain
» Critical Environments
Aggregation Of Therapeutic Proteins: Causes, Control, Consequences, And Challenges
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.
Variability In Sterility Test Processes And The Benefits Of Modular Workstations
The Role Of Double Wall Modular Cleanrooms In Aseptic Environments
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