7 Key Concepts In The FDA's Quality System Guidance For Pharma

By James Jardine

The FDA has an abundance of guidance for the pharmaceutical industry. One document that’s particularly important is the “Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations.” The guidance was created in 2006, and its purpose is to help pharmaceutical companies operate quality systems that are fully compliant with current good manufacturing practice (CGMP) regulations.

This guidance, and newer FDA regulations that have only recently been drafted, are encouraging pharma manufacturers to adopt digital tools to streamline operations, improve quality, and make it possible to produce drugs more efficiently and at a lower cost.

Here are some key concepts that the FDA deems critical for a discussion on modern quality systems and defines them within the scope of pharma manufacturing.