Quality - Pharmaceutical Technology

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PharmTech Europe

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

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.

Large Industry Cross-Section Contributes to PDA Quality Metrics Recommendations

February 2, 2014

Pharmaceutical Technology

PDA works with FDA to create pharmaceutical quality metrics.

Checklist for Computer Software Validation

February 2, 2014

Pharmaceutical Technology

Non-compliance issues show that users find dealing with computer systems challenging.

Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better

February 1, 2014

Pharmaceutical Technology

Traditional project decision-making is compared with a QbD approach.

National Cancer Institute Announces Genetic Sequencing Trial

January 30, 2014

NCI launches trial to assess the utility of genetic sequencing to improve patient outcomes.

Metrics Sought to Ensure Drug Quality

January 2, 2014

Pharmaceutical Technology

Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.

Calibration of instruments: Is Your UV Spectrometer Accurate Enough

January 2, 2014

Pharmaceutical Technology

This article takes a statistical look at the calibration requirements for a UV spectrometer.

Compliance in Quality Systems

November 2, 2013
Pharmaceutical Technology

Siegfried Schmitt of PAREXEL discusses regulation requirements for quality systems.

Tracking Quality in Drug Manufacturing

October 2, 2013

Pharmaceutical Technology

Recent FDA enforcement activity reveals issues with vial-filling, adequacy of QA/QC procedures, particulate matter in inhalation powders and injectables, and drug labeling.

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Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
30%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
30%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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