First four pages Extractable; Paper 01 -- Forrest; Paper 02 -- Hawkins; Paper 03 -- Nicholas; Paper 04 -- Worsoe; Paper 05 -- Markovic; Paper 06 -- Egert; Papers 7-11 -- Multi Authors; Paper 12 -- Hodgson; Paper 13 -- Martin; Paper 14 -- Stults; Paper 15 -- Feilden; Paper 16 -- Creasey; Paper 17 -- Senholt; Paper 18 -- Jenke; Paper 19 -- Toynbee; Paper 20 -- Claessens; Paper 21 -- Janssen; Paper 22 -- Wong
Summary
Impurities originating from any part of the manufacturing or storage of drug products can potentially result in expensive product recalls and damage to a company's reputation - not to mention the serious threat posed to patient safety. Nowadays extractables and leachables assessment of all materials - and especially elastomeric and plastic components - forms an integral part of the submission for approval of a new drug system or medical device. With regulatory authorities such as the FDA and the MHRA demanding assurance that a product's integrity has been scrutinised - the pharmaceutical indus