Quality Systems

Lynn D. Torbeck is an international consultant and trainer specializing in applied statistics and experimental design for pharmaceutical, biopharmaceutical, and medical device research and development, validation, quality control/assurance, and production, 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314.

Articles

A history of the selection of the widely used significance level leaves much to be desired.

Statistical Solutions: On the Verge of Significance: Why 5%

Martin Morrison is Technical Director at Axicon Auto ID Ltd.

The 2D Data Matrix barcode is a familiar sight for most pharmaceutical manufacturers as printing is implemented to meet certain regulations.

Data Matrix Barcodes: Print Quality and Popularity On The Up

A method for determining sample size is finally getting some respect.

Statistical Solutions: Bergum's Method Recognized

The Role of Statistical Significance Tests

Liquids are used in a wide variety of industries, either during manufacture or as end-products in themselves. Whatever the end product, quality control of liquids is crucial to many industries.

Quality control of liquids in the 21st century

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Angie Drakulich was editorial director of Pharmaceutical Technology.

Leading experts share insight on the current and future direction of process analytical technology. This article contains bonus online material.

PAT: A New Dawn for Drug Product Quality

Grace McNally, in the Office of Compliance at FDA's CDER, discusses the role of QbD and pharmaceutical quality systems as it relates to contract manufacturing.

A Perspective from FDA on ICH Q10 Pharmaceutical Quality System for Contract Manufacturers

The quality assurance environment is forcing pharmaceutical companies to face new challenges. In light of this, the authors conducted a study of professionals from some of the world's top pharmaceutical companies to identify key QA concerns.

Long-term QA trends in pharma

Is the square root of (N) + 1 a statistically valid scheme?

Statistical Solutions: Square Root of (N) + 1 Sampling Plan

The author of an ambitious book about quality control falls short of reaching his goals.

Quality Assurance/Quality Control