Analytical Quality Control News

Pharmaceutical Technology’s recent publication, authored by Chris Burgess, Chairman of the ECA Analytical Quality Control Group, takes a closer look at the relationships between data governance, integrity, and quality in the context of pharmaceutical analysis. The article aims to provide a structured model for these terms, including their definitions and interrelationships.

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter to a Chinese company registered as a manufacturer of over-the-counter (OTC) drug products. This action was based on a review of records that identified deficiencies in the company’s quality control unit, laboratory testing for the drug product, and the identity testing of incoming components.

The U.S. Food and Drug Administration (FDA) has recently published a new Warning Letter. The authority observed pest activity in the raw storage area, water leaks, and missing ceiling tiles in the drug manufacturing area. Furthermore, employees used the QC lab for non-CGMP activities, such as meal preparation and dishwashing.

In September 2024, the U.S. FDA issued a Warning Letter to the Indian company "MMC Healthcare Ltd." after having inspected its site in March 2024. According to the Warning Letter, the firm failed to have "appropriate controls to assure the integrity of electronic test data, such as an audit trail and defined user access levels".