Quality - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Quality
Essential information about quality assurance and quality control, including analytical methods, analytical method development, statistical methods, and process analytical technology (PAT).

Multifactor Non-linear Modeling for Accelerated Stability Analysis and Prediction

July 2, 2014

Pharmaceutical Technology

The right approach can provide a clear, statistically defendable method for determining dissolution and accelerated stability.

Securing the Supply Chain

July 2, 2014

Pharmaceutical Technology

Regulators and industry leaders take on the task of securing the drug supply chain.

FDA Issues Guidance on Identifying Suspect Drugs

June 17, 2014
PTSM: Pharmaceutical Technology Sourcing and Management

FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.

Wockhardt Cited by FDA for Quality Control Failures

June 4, 2014

FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

Using Interactive Response Technology to Manage the Manufacturing of Pooled Supplies

June 3, 2014

Kurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics discusses interactive response technologies and the management of pooled supplies.

One Step Back, Two Steps Forward to Improved Quality Processes

May 8, 2014

Life-sciences companies can get a jump on potential quality problems by looking at the leading indicators hiding in the document management process further upstream.

Linking Drug Shortages and Quality Metrics

May 2, 2014

Pharmaceutical Technology

Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.

Solid Dosage and Excipients

April 1, 2014

Review emerging trends in the formulation and manufacture of solid dosage drugs, as well as the role of excipients in enhancing the functionality of these drug forms.

Tandem Diabetes Care Expands Recall

February 13, 2014

Tandem Diabetes Care expands its voluntary recall of select lots of insulin cartridges used with t:slim insulin pump.

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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
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
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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