GMP News - APIs and Excipients

Glycerin is often used as an excipient in solid and semisolid dosage forms. For companies supervised by the FDA, comprehensive testing of the incoming excipient is mandatory. Otherwise, they risk receiving a warning letter, like an Irish pharmaceutical company recently did. The deficiencies the FDA inspectors found in the areas of quality control and quality assurance are described here.

To use an active substance in a form which ensures optimum processing is important for an efficient production process; but what does that mean for approval procedures? Read here how the FDA classifies active pharmaceutical ingredients in co-crystalline form during an approval procedure.

Several Ph. Eur. Monographs on excipients used in semi-solid formulations have been proposed for comment. Read more about the monographs on oils, fats, waxes, emulsifiers.

The attempt to conceal hygiene deficiencies with inaccurate lab data resulted in a virtually inevitable Warning Letter after an FDA inspection. Read here, which violations of fundamental GMP rules for maintenance and cleaning of production equipment at an API facility were criticised by the inspectors.

With an update of their guideline on NAT testing of blood and plasma donations for HIV-1 and HCV, the FDA takes account of the developments regarding methods and related regulations.

Data integrity is for sure still a hot topic in inspections. But it seems inspectors are getting more back to the roots: document and batch record design and review.

Fundamental violations of GMP basics in the area of API production found in an official inspection usually lead to unpleasant consequences or, in case of FDA inspections, to a Warning Letter. Read more on which issues concerning in-process controls, documentation and OOS results are intolerable.