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For parenteral products and solutions, inspections have shown that exactly where pyrogen difficulties were located in dosage sorts, and when the source was one of many raw components, it was the active drug substance. This was specially real for drug substances where approach water was used at some late stage while in the synthesis method.
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This ITG will target the significance and interpretation of pyrogen/endotoxin tests. Also sources and ways of depyrogenation will likely be talked over. The limitations of your rabbit pyrogen examination really should be regarded when reviewing techniques for the duration of inspections of sterile drug and device producers.
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Given that RO filters are not absolute, it might be essential to have them in collection so as to manufacture pyrogen-cost-free WFI. Whichever program is used, very good apply would come with the ability to isolate and Examine every bit of kit inside a WFI procedure. Confer with ITG No. 36, dated ten/21/80, for the discussion of Reverse Osmosis.
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