Analytical Quality Control News

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter highlighting significant violations of Current Good Manufacturing Practice (CGMP) regulations. These violations, identified through a review of records, include insufficient component testing, inadequate quality control, and improper stability testing.

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.