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. Extracables & leachables.

Is My Method (Still) Valid?

April 25, 2013

This paper outlines the importance of method validation including the official requirements, characteristics to be validated and minimum requirements, helping to ensure that the data generated are reliable.

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.

The Role of Analytical Science in Implementing Quality by Design

March 2, 2013

Pharmaceutical Technology

The authors present topics discussed and conclusions that resulted from the PDA QbD workshop.

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.

Be Prepared for Serialization

February 20, 2013

Equipment and Processing Report

Equipment purchased today for the packaging line should be serialization-ready in preparation for upcoming requirements.

Improving Inhaled Product Testing: Methods for Obtaining Better In vitro-In vivo Relationships

February 2, 2013

Pharmaceutical Technology

Even in an industry in which all product development is complicated by the intricacies of human biology, orally inhaled products (OIP) stand out as singularly demanding.

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How does your company apply quality-by-design (QbD) principles to manufacturing processes?
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Nathan Jessop Industry Insider Nathan Jessop Campaign Against Counterfeit Drugs Continues
Lynn Torbeck Statistical Solutions Lynn D. TorbeckCompositing Samples and the Risk to Product Quality
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