GMP News - Pharmaceutical Technology

In a recent Form 483 issued as part of an FDA inspection conducted at an Indian sterile manufacturer, the FDA criticized the manual visual inspection, among other things.

Parenterals must be 100% visually inspected. This is a clear requirement of the pharmacopoeias, just as it is clear that containers with particles must be sorted out. But do the particles found always have to be identified?

In the current Pharmaceutical Forum PF 47(3), a Stimuli article describes the weaknesses in the current specifications for testing parenterals for particles and how these could be addressed in a new USP chapter.

In February 2021, the WHO published the new Guideline "GOOD MANUFACTURING PRACTICES FOR MEDICAL GASES" on the manufacture, testing, storage and distribution of medical gases for comment. The reason for the WHO to create this new guideline is the increased demand for oxygen for ventilation due to the Corona pandemic.

Due to deficiencies in the ventilation system and particle monitoring in the sterile area, an Indian pharmaceutical manufacturer has recently received a Warning Letter from the U.S. FDA. In addition, the microbiology testing was also criticized.

A repacker in the US has recently received a Warning Letter from the FDA. The described deficiencies are repackaging of products in non-equivalent primary packaging, the lack of cleaning validation and the establishment of a suitable quality unit.

A US-American pharmaceutical manufacturer was inspected by the FDA in February 2020. Due to serious deficiencies in the media fills and smoke studies in the aseptic area, the manufacturer has now received a Warning Letter.