BRIEFING

 〈1664.5〉 Assessment of Leachables in Oral Drug Products. The General Chapters—Packaging and Distribution Expert Committee is proposing the following new general information chapter as a companion to Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems 〈1664〉. Based on comments received, the proposal in PF 51(5) has been canceled and is being replaced with a new proposal. This new chapter addresses specific considerations for leachables in oral dosage forms (ODFs), including liquids (solutions, suspensions, emulsions, elixirs, and syrups), semisolids and pastes, and solids (tablets, capsules, pills, powders, granules, and premixes). The chapter considers leachables from two sources: manufacturing systems used to produce the dosage form and container closure systems used to package the dosage form over its shelf life. Note that this chapter primarily discusses organic leachables. For consideration of elemental leachables, see ICH Q3D.

 (GCDF: R. Kaja)

 Case ID—SUB-3295