Pda Technical Report 82

Methods for introducing endotoxin into the product matrix.

It is crucial to note that PDA TR 82 is not a regulatory standard or a compendial chapter (like USP). It is a technical report —a best-practices guideline. However, regulators expect manufacturers to be aware of its contents and justify any deviation from its recommendations. pda technical report 82

TR 82 explicitly states what regulators will ask during an inspection: Methods for introducing endotoxin into the product matrix

Review all marketed and pipeline parenteral products. Flag any containing polysorbates (20 or 80), Cremophor, cyclodextrins, or EDTA. pda technical report 82