Pharma Talk

SOPs on Cleaning Validation not followed The FDA criticizes that the cleaning validation for non-dedicated equipment and its maintenance are...

The FDA has investigated the hi u need it ugtygsyjthz yubsybh fhgjeg bb manufacturiyng practices of Shantou Kangjie Daily Chemical Industry ...

Background During the COVID-19 pandemic, various exemptions were introduced for GDP inspections as well as for the validity and extension of...

On the website of the HMA (Heads of Medicines Agencies), under the heading "Variations", you will find the "Guidance Document...

In January 2025, the U.S. Food and Drug Administration (FDA) published a draft Guidance for Industry and other interested parties entitled ...

Failure to record all quality-related activities at the time they are performed. Your quality unit (QU) failed to ensure the integrity of CG...

Insufficient monitoring was carried out to ensure that the system was functioning properly and was suitable for production. FDA requirements...

Access Letter Here The system was poorly designed, e.g. with ‘blind spots’ and lack of continuous circulation, increasing the risk of biofil...

The European Medicines Agency EMA announced that the European Shortages Monitoring Platform (ESMP) started with the full scope of functional...

At the beginning of December, a news in the EDQM website newsroom informed that the Brazilian health authority ANVISA (Agência Nacional de V...