FDA to revisit GMP for raw materials

Staff reporter

30-Apr-2010

The US Food and Drug Administration says it plans to revise good manufacturing practice (GMP) regulations for incoming raw materials to help industry secure the pharmaceutical supply chain against economically-motivated adulteration, according to a report on FDAnews.com (subscription required).

The agency says it has not committed to any particular timeline for the revisions, but it expects they will significantly improve the control over suppliers, says the report.

The piece refers to comments made by Deb Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research, at the 2010 PDA/FDA Pharmaceutical Supply Chain Workshop in Bethesda, Maryland, earlier this week.

Features
Showcase
Research
Events

Wellcome Trust backs counterfeit drug analysis project
The Wellcome Trust has awarded £473,000 ($737,000) in funding to researchers in the UK and Sweden to create a low-cost instrument that can screen medicines for quality and authenticity.
Start-up aims to make pharma cargo tamper-proof
A security system to protect cargo containers and pallets from theft and tampering is promising to improve security in the pharmaceutical sector.
Brazil may swap its serialisation scheme for Turkish model
Brazil may back away from its current plans for a national serialisation system for drugs and adopt one closer to the Turkish model.