Where’s the weakest link in your compliance mechanism? While you may be well aware of the most problematic areas in the facilities you’re personally responsible for, supply chain compliance deficiencies have a way of sneaking up on [...] Read More
Corrective and preventive actions, or CAPAs, play a vital role in how GxP firms maintain compliance with FDA standards. A corrective action (CA) is an action to eliminate the cause of a detected nonconformity, or any other situation deemed to have adverse effects on a drug product. A preventive action (PA) is an action to eliminate the [...] Read More
Regulations outlined in FDA CFR 21 state that manufacturers must implement and maintain processes for corrective and preventive actions. Also known as CAPA systems, the implementations that deal with such actions take many forms, but they’re of the utmost importance for maintaining compliance not only in the United States, but the European Union as well.
What Does CAPA Do?
CAPA [...] Read More