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

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PharmTech

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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.

Parametric Release and Real-Time Release Testing

May 1, 2012
Pharmaceutical Technology

Parametric release and real-time testing use manufacturing data to ensure that products are made according to defined standards. PharmTech talks to Boehringer Ingelheim's Heribert Hausler about these issues.

Atomic Force Microscopy

May 1, 2012

Pharmaceutical Technology Europe

An analytical technique that is receiving increased attention in the pharmaceutical industry is atomic force microscopy. We interview Mark Leaper from the UK's De Montfort University to find out more about this technology.

Biological Indicator Growout Times: The Impact on Establishing a Reduced Incubation Time Protocol

May 1, 2012

Pharmaceutical Technology

The authors provide a review of test methodology and standards, including current industry and regulatory proposals, for biological indicator growout times.

Bioprocessing Trends: Annual Survey Results

May 1, 2012

Pharmaceutical Technology

Readers share their views on bioprocessing challenges, equipment use, and outsourcing trends in our annual bioprocessing equipment and processing survey.

In the Spotlight

April 2, 2012
Pharmaceutical Technology

New product reviews for April 2012.

Loose Lips Sink Ships

April 2, 2012

Pharmaceutical Technology

Failure to disclose info may work sometimes, but eventually every question will be answered.

Managing Product Supply Risks

April 2, 2012

Pharmaceutical Technology

How to use geographic diversification and legacy technology transfers to avoid product shortages.

Total Recall

March 2, 2012

Pharmaceutical Technology

In a world where product recalls can mean the end of a company, all batches must be perfect.

Genotoxic Impurities: A Q&A with Amgen's Bo Shen

March 2, 2012

Pharmaceutical Technology

Genotoxic impurities and how to identify them and control for them have been a concern for several years in the pharmaceutical manufacturing industry. Pharmaceutical Technology spoke with Bo Shen, PhD, principal scientist at Amgen and chair of the AAPS Pharmaceutical Trace Impurities Focus Group, to gain insight on key challenges.

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