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.

Demonstrating Biosimilarity

August 2, 2013

Pharmaceutical Technology

Extensive comparability testing is required to ensure that biosimilars have comparable profiles to their reference products.

Fast Locator 2013-2014 Index

August 1, 2013

View companies' outsourcing profiles from PharmTech's 2013 Outsourcing Resources Fast Locator Index in the following categories.

Analytical and Bioanalytical Testing

July 15, 2013

View case studies of chromatographic, spectroscopic, and imaging methods used in the identification, characterization, and quantification of drug substances products.

Evaluating Risk-Based Specifications for Pharmaceuticals

July 2, 2013

Pharmaceutical Technology

The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution.

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.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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