When the CCS Is Out of Date or Too Vague One common issue inspectors flag is a CCS that hasn’t been reviewed in a long time. In some...

Media fills, or Aseptic Process Simulations (APS), are meant to show that a company’s aseptic process is under control. They are a key...

Facility issues might not always look serious at first. But in recent inspections, regulators have shown that even small signs of damage...