Analytics: Approaches in quality assurance and quality control used in pharmaceutical development and manufacturing - Pharmaceutical Technology

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PharmTech Europe

Analytics
Analytical testing methods in pharma manufacturing. Chromatography, UHPLC, chiral. Near-infrared (NIR) and Raman spectroscopy. Anticounterfeiting. Dissolution testing. Cleaning validation. Extractables & leachables.

Methods for Identifying Out-of-Trend Results in Ongoing Stability Data

June 2, 2013

Pharmaceutical Technology

The authors discuss three methods for identification of out-of-trend (OOT) results and further compare the z-score method and the tolerance interval in OOT analysis for stability studies.

Microwave Spectroscopy for Enantiomeric Detection of Chiral Molecules

June 2, 2013

Pharmaceutical Technology

Microwave spectroscopy overcomes some of the limitations of circular dichroism and vibrational circular dichroism in analyzing enantiomers.

Compositing Samples and the Risk to Product Quality

May 2, 2013

Pharmaceutical Technology

Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied.

Enhancing Particle-Size Measurement Using Dry Laser-Diffraction Particle-Size Analysis

May 2, 2013

Pharmaceutical Technology

The author examines dry dispersion and outlines the related analytical method development.

Preparing for Serialization

March 20, 2013

Equipment and Processing Report

Bristol-Myers Squibb embarks on a multi-year journey to overcome the challenges of serialization and reap the benefits.

Advancing analytical testing and instrumentation for biopharmaceuticals

March 2, 2013

Pharmaceutical Technology

Instrument manufacturers and testing service providers are offering improved tools to biologic charaterization.

Advances in PAT for Parenteral Drug Manufacturing

March 2, 2013

Pharmaceutical Technology

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

Catching Up

March 2, 2013

Pharmaceutical Technology

QbD paradigm advances process understanding in development and manufacturing.

The Lifecycle Change of Process Validation and Analytical Testing

March 2, 2013

Pharmaceutical Technology

Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry.

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