News

In February 2022, the U.S. FDA issued a Warning Letter (WL) to an Indian drug manufacturing site called "Indiana Chem-Port" due to significant violations of cGMP regulations for active pharmaceutical ingredients (APIs).

The US Government Accountability Office (GAO) has released a report to Congress entitled "FDA Should Take Additional Steps to Improve Its Foreign Inspection Program".

In order to support its members, but also to support the industry in general in implementing the requirement of the upcoming revised Annex 1 for a Contamination Control Strategy, the ECA has published a CCS Guideline. This document provides guidance and a template for the development of a contamination control strategy.

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian drug manufacturer. During an inspection, it was observed that the firm combined returned capsules from various lots into new batches, resulting in new lots with no uniform character and quality. The FDA also criticizes the firm’s stability programme and validation activities.