FDA's quality systems methodology at pharmaceutical manufacturing sites

This research details the FDA's quality systems methodology used in its inspection of biopharmaceutical manufacturers in the time period between 2003 and 2009. It analyzes the violations specified in FDA site inspection warning letters, reviewing their frequency and specificity. This analysis i...

Full description

Saved in:
Bibliographic Details
Published in:Communications of the IIMA 2011-01, Vol.11 (1), p.27
Main Author: Adis, Warren
Format: Article
Language:English
Subjects:
Biological products
Compliance
Drugs
Enforcement
Federal regulation
Inspections
Manufacturers
Manufacturing
Mathematics
Pharmaceutical industry
Pharmaceuticals
Quality control
Quality management
Quality standards
Regulatory agencies
Studies
Technology application
Violations
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:This research details the FDA's quality systems methodology used in its inspection of biopharmaceutical manufacturers in the time period between 2003 and 2009. It analyzes the violations specified in FDA site inspection warning letters, reviewing their frequency and specificity. This analysis is an exploration into FDA activity in this sector, focusing particularly on finished pharmaceuticals, and serves as an initial evaluation of the FDA's performance. In addition, the study pays particular attention to whether the FDA's risk methodology has enhanced the overall inspection process and increased its quality assurance.
ISSN:1543-5970
1941-6687