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.

X-ray Powder Diffraction Pattern Indexing for Pharmaceutical Applications

January 1, 2013

Pharmaceutical Technology

The authors discuss the valuable information that can be obtained from indexing and its applications in routine screening and analysis of solid forms.

Tablet Splitting and Analytical Technologies

January 1, 2013

Tim Freeman of Freeman Technology explains how new analytical technologies have influenced quality criteria and standards for the uniformity of dosage units, and why more accurate systems are leading to greater focus on tablet scoring.

Using Magnetic Separation to Remove Contamination

December 19, 2012
Equipment and Processing Report

Magnetic separation equipment reduces ferrous metal contamination.

Harnessing the Power of Fingerprinting Technologies

December 2, 2012

Pharmaceutical Technology

A few years ago, drug criminals would put all their efforts into matching packaging and labeling, or manufacturing good-looking fake materials. Today, criminals are capable of much more.

Patents and Postapproval Batch Testing

December 2, 2012

Pharmaceutical Technology

Can postapproval FDA filings immunize pharma companies from patent lawsuits?

Using As-Found Data in a Pipette Calibration Program

November 21, 2012
Equipment and Processing Report

As-found data is a crucial component of pipette calibration for laboratories that must comply with GMP regulations.

Mean Kinetic Relative Humidity: A New Concept for Assessing the Impact of Variable Relative Humidity on Pharmaceuticals

November 2, 2012

Pharmaceutical Technology

This article introduces"mean kinetic relative humidity" for evaluating the impact of humidity variability.

AAPS Workshop Summary

November 2, 2012

Pharmaceutical Technology

A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.

Examining the Growing Challenge of Extractables and Leachables

November 2, 2012

Pharmaceutical Technology

Experts share insight into extractables and leachables testing, including high-risk products, analytical testing, and regulatory requirements from FDA and EMA.

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