Quality Systems

Articles

Achieving a consistent level of quality control could greatly reduce waste and save money for the pharmaceutical industry. But why has talk about Six Sigma died down at a time when it could be of great benefit?

Is Six Sigma Still Relevant for Drugmakers?

EMA has concluded in a recent report that a pilot program investigating the mutual benefits of joint international inspections of API manufacturing facilities has been a success. FDA has also reached a similar conclusion based on the findings.

FDA, EMA Say Future Joint API Inspections Likely

The International Society for Pharmaceutical Engineering published a guidance document that defines current best practices in pharmaceutical manufacturing applications for handling gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams.

ISPE Publishes Guide for Process Gases

Quality management requires more effort in a complex supply chain.

Has Outsourcing Derailed PAT and QbD?

Pfizer's Experience with QbD. This article is part of a special issue on Outsourcing.

A Pharma Manufacturer's View of Quality by Design

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Supplier differentiation is increasingly important in the highly competitive arena of pharmaceutical outsourcing.

Standing Out in the Crowd

An Industry Roundtable Moderated by Patricia Van Arnum and Rich Whitworh. Contract service and technology providers share their perspectives on the influence of quality by design in the expectations between sponsor companies and outsourcing providers.

Evaluating QbD's Impact on the Outsourced Relationship

We?re attempting to validate a clean-in-place process using total organic carbon (TOC) as the analytical method. Our swab-sample recovery tests are giving us inconsistent results. Recovery values range from 95% to 205%, and there seems to be no correlation with the amount of drug product deposited on the coupon. What could be the problem?

Erratic Recovery-Test Results

FDA banned the importation of products manufactured at the Mexican unit of Dr. Reddy's Laboratories. The import ban is a result of the company's failure to correct the violations listed in a recent Warning Letter to the agency's satisfaction.

FDA Bans Import of Drugs from Dr. Reddy's Mexico Site

A PQRI expert working group provides case study examples of risk-management applications.