PDA TR 79

PDA Technical Report No. 79, Particulate Matter Control in Difficult to Inspect Parenterals describes best practices for difficult to inspect parenteral (DIP) product lifecycle management, destructive testing, and trending to supplement portions of the guidance given in USP General Chapter<1790>: Visible Particulates in Injection. In 2015, the PDA Task Force on Particulate Matter Control in Difficult to Inspect Parenterals initiated an industry survey on DIP products. literature, pharmacopeial references, and the collective expertise of Task Force contributors form the basis for the information provided in this technical report. This Technical Report is intended to provide logical pathways to DIP product inspection and testing to support continual process improvement in the industry.