Quality Systems

Articles

Siegfried Schmitt of PAREXEL discusses regulation requirements for quality systems.

Compliance in Quality Systems

Patricia Van Arnum was executive editor of 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.

Tracking Quality in Drug Manufacturing

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

The Basics of Measurement Uncertainty in Pharma Analysis

Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party to be in keeping with quality risk-management principles.

Defining Quality Agreements

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

Greater sophistication in 3D X-ray imaging technology raises its utility for QA/QC in manufacturing.

Addressing Manufacturing Challenges with Nondestructive X-Ray Imaging

Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied.

Compositing Samples and the Risk to Product Quality

The mysteries of rounding are exposed; strict, unbiased rounding can be applied.

Rounding Results for Comparison with Specification

Two methods to evaluate retest data following out-of-specification results.

Calculating the Reportable Result from Retest Data

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

Shortages and compounding disaster spur efforts to overhaul manufacturing oversight and stimulate industry improvements.

Drug Quality at Center Stage for FDA and Manufacturers

A change in terminology could emphasize patient protection.

Quality Assurance/Quality Control