What is the Optimal Temperature for Sanitizing Water Systems?
Thermal sanitization is still the most common method for keeping pharmaceutical water plants under microbiological control. Some systems are stored at high temperatures - but often water systems are heated up cyclically to an elevated, germicidal temperature. Here, the question of optimal temperature often arises.
ICH publishes Guideline Q13 on Continuous Production
End of July 2022, the ICH (International Council for Harmonisation) published the draft guideline on continuous manufacturing, which had been awaited for two years. In addition to batch definitions, the document describes three different continuous manufacturing approaches and provides guidance on control strategy and approval issues.
Dealing with Particulate Findings in 100% Visual Inspection
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?
Deficient Cleaning and Transfer of a Non-Validated Manufacturing Process Lead to a Warning Letter
During an inspection of an Indian pharmaceutical manufacturer by the FDA, several serious deficiencies were discovered. For example, the cleaning of multipurpose equipment was criticised, and the transfer of a non-validated manufacturing process led to further complaints. Read more here.
New USP Chapter on Visual Inspection of Parenterals?
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.
Warning Letter due to Inadequate Pressure Stage Concept and Particle Monitoring
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.
Warning Letter to Indian Manufacturer: Dead Legs and Missing Validation
Due to the deficiencies identified during an inspection that the FDA had already conducted in February 2020, an Indian pharmaceutical manufacturer has now received a Warning Letter. The main reasons for this were deficiencies in equipment design, validation and incoming goods inspection. Read more here.
Warning Letter for US Repacker: Deficienceis in Cleaning and Stabilities
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.
Deficiencies in Media Fills and Smoke Studies: Warning Letter
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.
British Authority Criticizes Insufficient Prevention of Cross Contamination
The British health authority MHRA has recently published a statement in its blog, which reports about insufficient measures to avoid cross contamination in multipurpose facilities. This has been noticed in recent inspections.