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Effective July 1, 2008, the Office of Generic Drugs (OGD) will require abbreviated new drug applications (ANDAs) to include data that demonstrate the manufacturer's control of residual solvents.
Rockville, MD (May 27)-Effective July 1, 2008, the Office of Generic Drugs (OGD) will require abbreviated new drug applications (ANDAs) to include data that demonstrate the manufacturer’s control of residual solvents. This requirement will also apply to unapproved ANDAs still under consideration on July 1. In addition, OGD will require companies to provide residual-solvent data for approved products in the next annual report for each relevant ANDA.
These requirements coincide with the effective date of US Pharmacopeia <467>, which addresses the levels of residual solvents acceptable for drug products for which there is a USP monograph. The chapter is intended to ensure the safety of the drug products and is derived from the International Conference on Harmonization (ICH) Q3C quality guidance. OGD stated that all drug substances, excipients, and products “are subject to relevant control of residual solvents, even when no test is specified in the individual USP monograph.”
In the May 2008 letter announcing these requirements, OGD said that the specifications for residual solvents in ANDAs should either:
• Ensure that all drug substance and excipient components of the drug product have residual-solvent acceptance limits within the ICH Q3C (option 1) limit
• Or ensure that all drug substance and excipient components of the drug product, weighted by their amount in the drug product, result in a cumulative daily exposure for residual solvents that falls within the ICH Q3C (option 2) limit
• Or ensure through direct testing of the drug product that the total daily exposure for residual solvents falls within the ICH Q3C (option 2) limit.
OGD also requires sponsors to explicitly commit to reassessing their compliance with USP <467> if they change ingredient suppliers after a drug has been approved. The office announced that ANDAs for noncompendial products will also be required to contain information that demonstrates levels of residual solvents in the drug product that are consistent with USP <467>.