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 [...] Read More
Quality risk management implementation identifies and manages risks; under normal circumstances the [...] Read More
Electronic record keeping [...] Read More
- Reducing the likelihood that unsafe, ineffective, and poor quality drugs will enter the supply chain and reach consumers.
- Raising public awareness of [...] Read More
The FDA’s Quality System Regulation shouldn’t [...] Read More
GxP-CC has achieved ISO 9001:2008 certification. Developed by the International Organization [...] Read More
Your firm’s pharmaceutical products aren’t the only things subject to U.S. and international regulations. For decades, agencies like the FDA have also required manufacturers to adhere to a range of best practices that include management of production facilities and supply [...] Read More