Publisher's Synopsis
As in Europe, the examination of extractables and leachables is growing in importance in the USA, due to increased regulatory scrutiny from the Food and Drugs Administration (FDA). Regulators are concerned with the interaction of various drug delivery devices, such as metered dose and dry powder inhalers (MDI and DPI) and now parenterals and ophthalmics are of increasing interest, as well as pharmaceutical process equipment. It is therefore essential that any company involved in the supply chain - from raw material suppliers, processors, converters to the pharmaceutical supplier - is fully aware of the latest developments and best practice in generating test results and data to support successful regulatory submissions to both the FDA and EMEA.
