News

With Version 7.0, Swissmedic expands the options for demonstrating the GMP compliance of FDA-inspected active substance and medicinal product manufacturers.

More

In a recently published Warning Letter, the FDA describes significant and repeated CGMP deficiencies at a U.S. manufacturer of over-the-counter (OTC) products. The observations concerned incoming material controls, stability testing, process and cleaning validation, quality unit oversight, and the implementation of previously committed corrective actions.

More

In the 'Compilation of Union Procedures on Inspections and Exchange of Information', the document on the coordination of GMP inspections for centrally authorised medicinal products has been updated. However, the changes are only minor and mainly concern supporting authorities.

More

During an inspection in March 2026, the FDA identified deficiencies in the programme for the visual inspection of sterile injectable medicinal products. In the Warning Letter, the authority particularly criticises the inadequate qualification of inspection personnel, as well as deficiencies in the qualification kit and documentation.

More

An EU-based sponsor has withdrawn its marketing authorisation application for a monoclonal antibody submitted to the European Medicines Agency (EMA), following unresolved concerns about the contract manufacturing site's GMP compliance that had also affected the FDA approval process.

More

A recent Warning Letter issued by the U.S. Food and Drug Administration (FDA) highlights how inadequate quality unit oversight, warehouse segregation and lot-level traceability can undermine the control of OTC drug products.

More

Two recent FDA Warning Letters highlight a recurring weakness in pharmaceutical quality systems: treating an investigation as complete before the organisation knows what really happened, assessed the full product risk, and implemented actions capable of preventing recurrence.

More

The FDA has criticised Suretec Innovations for serious GMP deficiencies – particularly in relation to microbiological testing, the assessment of abnormal microbial count results and the release of potentially affected batches. Read the summary to find out what other shortcomings the authority identified and why the quality department failed to fulfil its responsibilities adequately.

More

The FDA recently sent a Warning Letter to a European company, listing an astonishing range of shortcomings. These ranged from issues relating to personnel hygiene to data integrity. Many of the areas highlighted should now form part of the contamination control strategy.

More

During an inspection, the FDA identified a whole series of breaches of the sterile manufacturing regulations, ranging from hygiene shortcomings and monitoring gaps to inadequate handling of deviations.

More
x
Search