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.

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.

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.

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.

Modernization of the Standards for Elemental Impurities

February 2, 2013

Pharmaceutical Technology

Recent activity in standards-setting organizations has raised interest in the impact of testing for impurities that may enter the product before it is mined or harvested or even due to intentional use of some reagents.

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.

Logging the Cold Chain

January 16, 2013

Equipment and Processing Report

Advances in data loggers and radio-frequency identification tags help meet the increasing need for managing the pharmaceutical cold chain.

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.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
35%
Breakthrough designations
12%
Protecting the supply chain
35%
Expedited reviews of drug submissions
12%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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