ABSTRACT
This chapter is intended to assist to the extent possible, in the establishment of a single set of global specifications for new drug substances and new drug products. It provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin, and new drug products produced from them, which have not been registered previously in the United States, the European Union, or Japan. Guidance is provided with regard to acceptance criteria, which should be established for all new drug substances and new drug products, that is, universal acceptance criteria, and those that are considered specific to individual drug substances and/or dosage forms. The concept of different acceptance criteria for release vs. shelf-life specifications applies to drug products only; it pertains to the establishment of more restrictive criteria for the release of a drug product than are applied to the shelf life.
