As D-day approaches for the final round of GMP compliance, a preliminary review of what inspectors have found so far gives small-tier companies an insight of what to expect.
Paper. Inspectors are going to want to see lots of it, in the form of master manufacturing plans, standard operating procedures, and records of all sorts.
“FDA takes a risk-approached approach. What are the areas of risk right now for FDA? Let’s look at (contamination), and that the products are made as they are written up to be made, and that there aren’t accidental overages that could potentially raise a red flag,” said Daniel Fabricant, scientific affairs vice president for the Natural Products Association.
“White mounds of paper,” Fabricant said. “If you don’t write it down, it didn’t happen.”
On June 25, the third and final phase of tougher GMP rules goes into effect. Those companies with 20 or fewer employees must be in full compliance with the Food and Drug Administration guidelines.
The Good Manufacturing Practices rule was first rolled out in draft form by the FDA in June 2007. The final rule was introduced in October 2007. The first deadline in June 2008 for compliance applied to companies with 500 or more employees, followed a year later by companies with 21 to 499.