Qualified Contract Labs Can Be Used for Testing Residual Solvents

Contract laboratories can be used to test for residual solvents in excipients, but they should be qualified by ANDA sponsors and listed in applications, according to a question-and-answer document issued by a coalition of drug industry associations.

The document, prepared to clarify the FDA’s new requirements for residual solvents, is from the Coalition for Rational Implementation of USP General Chapter <467>. The coalition, led by the International Pharmaceutical Excipients Council (IPEC), includes the Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association, the Consumer Healthcare Products Association and the Society of Chemical Manufacturers and Affiliates.

The FDA’s new policy on residual solvents has raised a number of questions in the generic drug industry about how to comply with the requirements — including a number of ANDA deficiency letters sent by the agency to generic companies, Dave Schoneker, chairman for IPEC-Americas, said.
Drug GMP Report