Quality Systems

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Articles

CPhI experts make predictions on pharma trends for 2015.

Quality is Key

Experts review considerations for selecting excipients for solid-dosage drug performance and manufacturability.

New Excipient Options for Oral Solid Dosage Drugs

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.

The Quest Continues for Quality Metrics

Innovative Excipients in Solid-Dosage Manufacturing

Paul Kippax is a product manager, Laser Diffraction, Malvern Instruments Ltd., Enigma Business Park, Grovewood Road, Malvern Worcestershire, UK WR14 1XZ, Paul.Kippax@malvern.co.uk.

Analytical procedures and method validation should be developed with a structured and rigorous approach.

AQbD Adds Rigor to Method Development

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

The parenteral manufacturing industry is taking action to address particulate contamination issues.

Parenterals, Particulates, and Quality by Design

Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.

A Robust CAPA System for a Global Supply Chain

With a quality-by-design approach, robust processes can help deliver quality product consistently.

QbD Facilitates Robust API Development

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

Using Quality by Design to Develop Robust Chromatographic Methods

With a quality-by-design approach, robust processes consistently can help deliver quality product.