Preparing for and Managing FDA Inspections
By Sharry Arora, Bhaskar Saxena -
Published 13 December 2017
The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish.
Categories: Features, US, FDA, Compliance, Drugs, Manufacturing
Tags: Inspections, GxP, Quality Management System, QMS, CAPA, CMC, Validation, Form 483, Quality Assurance
Thailand's Approach to Drug Quality Assurance: Creation of the Green Book
By Thanita Patthamajinda, RPh -
Published 27 April 2017
This article discusses how Thailand's Ministry of Public Health (MOPH), Food and Drug Administration (Thai FDA) and a number of government and independent health agencies regulate drugs, both new and generic, as well as traditional, nonwestern medicines.
Categories: Features, Asia, Drugs, Quality
Tags: Thailand, Green Book, Quality Assurance
The Measure of Quality
By Jennifer DiMarco -
Published 29 November 2016
This article details how regulatory professionals can measure the quality of the outputs generated from the quality department. Additionally, the terms Quality Assurance (QA), Quality Control (QC) and quality management are often erroneously used interchangeably. Included are details about how these terms differ.
Categories: Features, Quality
Tags: Quality assurance, Quality control, Quality management