When it comes to being prepared for an inspection from a regulatory authority, the combination of preparation and practice will often make the difference between...

How a CAI agent helped make a difference (more…)

  (more…)

Annex 1 - "Manufacture of Sterile Medicinal Products." was first published in 1971. However, the first revision since then is currently in process. And this...

The word “visible” in the expression, Visual Inspection of Parenteral Products, has no meaning unless the viewing conditions are specified.  (more…)