GMP News - Quality Assurance

The FDA finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco products.

The European Parliament and Council agree to proposals from the EU Commission to ensure the continued supply of medicines to Northern Ireland, Cyprus, Ireland and Malta. Both a directive and a regulation are now in place.

Currently there are no compendial standards available for metal packaging systems for pharmaceutical use. Thus any other guidance providing information on metal components like the revised EDQM technical guide “Metals and alloys used in food contact materials and articles” can be useful.

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian firm that utilizes Contract Manufacturing Organizations (CMOs) to manufacture nasal spray products. The FDA criticises the lack of a quality unit (QU), an insufficient investigation into microbial contamination and an inadequate stability program.

The US Food and Drug Administration (FDA) is trying to revive its somewhat forgotten Quality Metrics Reporting Program. Now the FDA is asking for specific feedback.

In March 2022, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to an American over-the-counter (OTC) drug product manufacturer due to significant violations of Current Good Manufacturing Practice (CGMP). The violations were related to identity testing, training, calibration, qualification and quality unit oversight.