Procedures

One of the top citations in FDA 483’s and warning letters every year is companies failing to follow their own procedures.

As an industry, we tend to write long procedures (sometimes 20, 30 pages or more) consisting primarily of black-and-white text, often in paragraph form.

Yet, numerous studies have shown that the brain processes visual information – colors, pictures, and symbols – exponentially faster than black and white text.

GMP Habits

Creating strong everyday GMP habits starts with procedures that are clear, concise, visual, and user-friendly  – and following them precisely every day.

This also means involving the end user in the SOP creation and revision process, as the author, or at least a reviewer. Why? Because the end users are the ONLY audience that really counts for written procedures. They are the people that follow the procedures. They need to be involved in creating them.