Month: December 2023

Validation or Qualification concepts In the pharmaceutical industry, the concept of qualification refers to a systematic process used to ensure that equipment, facilities, utilities, and systems are suitable for their intended purposes and operate effectively and reliably. Qualification is a critical component of Good Manufacturing Practice (GMP) and is required to meet regulatory standards, such … Read more

FDA 483 WARNING LETTER : A Form FDA 483, officially titled “Notice of Inspectional Observations,” is a document used by the U.S. Food and Drug Administration (FDA) during inspections of regulated facilities. The purpose of this form is to communicate to the inspected entity, typically a pharmaceutical, biotechnology, or food manufacturing facility, any observed deviations … Read more