Quality Systems

Angie Drakulich was editorial director of Pharmaceutical Technology.

Articles

The American Society for Quality (ASQ), a membership organization that focuses on quality training in several industries including pharmaceuticals and healthcare, has adopted a new certification for good manufacturing practice (GMP) professionals.

New GMP Professional Exam Offered

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Frank Torti, currently principal deputy commissioner and chief scientist of the US Food and Drug Administration, will take over as FDA's acting commissioner next week, according to an official with the US Department of Health and Human Services (HHS).

Torti Named FDA's Acting Commissioner

The authors propose that a postapproval management plan can serve as a tool to apply science- and risk-based approaches to the manufacturing process.

The Postapproval Management Plan

The US Food and Drug Administration dedicated historic Building One at the White Oak Federal Research Center in Silver Spring, Maryland.

FDA Dedicates Building One at White Oak Research Center

The Pharmaceutical Research and Manufacturers of America (PhRMA) adopted measures to strengthen its Guiding Principles for Direct to Consumer (DTC) Advertisements about Prescription Medicines.

PhRMA Revises Principles for DTC Ads

Reps. John D. Dingell (D-MI), current chairman of the Committee on Energy and Commerce in the US House and Representatives, and Bart Stupak (D-MI), chairman of that committee?s Oversight and Investigations Subcommittee, said that moving the Food and Drug Administration Globalization Act and other measures for drug and food safety will be a key priority for the next Congress.

Lawmakers Pledge to Move on FDA Reform in the Next Congress

A recent Pharmaceutical Technology survey examined the level, sources, and reasons behind innovation in drug development and manufacturing. This article contains bonus online-exclusive material.

Gauging Innovation in Pharmaceutical Development and Manufacturing

The Steering Committee and Expert Working Groups of the International Conference on Harmonization are meeting this week in Brussels to discuss current harmonization efforts.

ICH Leaders Meet

The US Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE), a not-for-profit organization comprising 11 universities, a $1.19 million contract to develop quality by design (QbD) guidance elements for design space and scale-up of unit operations.

FDA Awards NIPTE $1.19 M for QbD Guidance Project

A bill that would require country-of-origin labeling for active and inactive ingredients for all prescription and over-the-counter pharmaceuticals was introduced in the US Senate last week.

Quality by Design