Quality Systems

Articles

As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.

A Compliance Perspective on Dissolution Method Validation for Immediate-Release Solid Oral Dosage Forms on Automated Instrumentation

Microsoft Corporation (Redmond, WA) announced the winners of the Microsoft Pharmaceuticals and Life Sciences Innovation Awards 2006 at this year?s meeting of the Drug Information Association in Philadelphia, Pennsylvania. A four-person panel of industry experts selected winners for the innovative use of Microsoft products in pharmaceutical and life sciences business processes and practices.

Supply Chain Technology, Real-Time Quality System Win Microsoft Awards

I always suspected that our purchasing manager had agreed to this just to save money . . .

The Fine Print

Guidance for reducing the risk of dissolved ozone measurement and addresses proper installation, calibration, and verification to ensure the best possible answers from dissolved ozone analysis. 

Dissolved Ozone in Pharmaceutical Water Systems: How and Where to Measure Dissolved Ozone

Though dissolution testing has been under scrutiny, it is still a powerful test method.

Challenges to the Dissolution Test Including Equipment Calibration

Extractable and leachable issues should be resolved early in the drug manufacturing process. Open communication is imperative for a successful study.

Identification and Risk-Assessment of Extractables and Leachables

Using the Bergum Method and the MS Excel software program, the author determines the probability of passing the USP dissolution test.

Using the Bergum Method and MS Excel to Determine The Probability of Passing the USP Dissolution Test

Coordinating validation efforts throughout an organization requires an accurate and timely overview and a validation master plan (VMP).

Computer Validation Master Planning "Validation Strategies"

Risk analysis and evaluation of software and computer systems is a good tool to optimize validation costs by focusing on systems with high impact on both the business and compliance.

Risk-Based Validation of Commercial Off-the-Shelf Computer Systems

A radiotracer technique is a simple, fast, and sensitive technique for analyzing the integrity of clinical supply packages to water.

Quality Assurance/Quality Control