Quality Systems

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Biopharma manufacturers must reduce the risk in their complex supply chains

Acute Need for Supply Chain Transparency

Ronald D. Snee, PhD, is president of Snee Associates, 10 Creek Crossing, Newark, DE, 19711 tel: 610.213.5595, fax 302.369.9971.

Control charts that are properly constructed and maintained prevent false out-of-control signals and provide a useful method for monitoring a process.

Reducing False Out-of-Control Signals

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to ensure data integrity.

Data Integrity

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

Statistical analysis shows how much testing is needed to deliver a reliable estimate result.

Is a Sample Size of n=6 a 'Magic' Number?

A drug sponsor?s responsibility does not end when a task is outsourced.

Key Considerations for Quality-Technical Agreements

Jennifer Goldsmith is vice-president of Vault at Veeva Systems.

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.

One Step Back, Two Steps Forward to Improved Quality Processes

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

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

Linking Drug Shortages and Quality Metrics

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

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

Calibration of instruments: Is Your UV Spectrometer Accurate Enough

PharmaCheck, a portable tool designed to detect poor-quality medicines, has been selected by Scientific American as one of the magazine?s World Changing Ideas of 2013.

Drug Quality Screening Technology Recognized

An operational-excellence initiative increased collaboration between operations and quality personnel to address human-error-caused deviations.

Quality Assurance/Quality Control