As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...

Whether monitoring temperatures at receiving, throughout production or final product storage and distribution, thermometer verification is essential. The validation, verification reassessment section ...

Environmental system designers are frequently asked where to position sample points for particle monitoring, whether it is conducted in a clean device (Isolator, RABS, etc.) or a pharmaceutical ...

In the pharmaceutical industry, cleanrooms are categorized based on the level of airborne particle concentration necessary to meet the cleanliness standards required for the specific manufacturing ...

The mass production of pharmaceuticals has significantly evolved since the industrial fabrication of synthetic drugs towards the end of the 19 th century 1 with efficient developments in process ...