BRIEFING

 〈1664.3〉  Assessment of Leachables in Topical Ophthalmic Drug Products. It is proposed to add this new chapter as a companion to Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems 〈1664〉. This new chapter addresses specific considerations for leachables in topical ophthalmic drug products (ODPs), including solutions, suspensions, emulsions, and ointments. The chapter examines leachables from two primary sources: process equipment used to produce the dosage form and container closure systems used to package the dosage form over its shelf life. Note that the following discussion is primarily devoted to organic leachables. For consideration of inorganic (i.e., elemental) leachables, see 〈1664〉.

 (GCDF: R. Kaja)

 Case ID—SUB-2478