Article preview from "The Gold Sheet" November 25, 2008
Read about how the FDA’s Office of Generic Drugs has taken a more flexible approach in implementing the U.S. Pharmacopeia’s General Chapter <467> on residual solvents.
Article preview from "The Gold Sheet" November 25, 2008
FDA Offers More Flexibility on Residual Solvents in Generic Drug Applications
FDA’s Office of Generic Drugs has taken a more flexible approach in implementing the U.S. Pharmacopeia’s General Chapter <467> on residual solvents.
OGD’s new policy allows manufacturers to verify excipient makers’ statements that their materials are within specified residual solvent limits without submitting underlying test data attesting to the accuracy of these statements.
OGD issued the policy on its website Oct. 28 as a question-and-answer page on residual solvents in abbreviated new drug applications.
The revision appears to allay the concerns of generic drug manufacturers and excipient suppliers who had complained that OGD’s earlier interpretation of USP Chapter <467> went beyond its original intent.
In response to industry’s concerns about meeting these new requirements, FDA also announced in the revised policy that drug manufacturers will have six months upon approval of their applications to verify excipient makers’ statements for controlling residual solvents.
In May 2008, OGD announced that starting on July 1, manufacturers must demonstrate in their ANDAs that their drugs comply with the residual solvent limits specified under USP Chapter <467>.
The USP chapter is modeled on the ICH Q3C guideline, which is meant to control impurities in 59 residual solvents. The ICH guideline, which was adopted in July 1997, establishes three classes of solvents according to their toxicity levels: Class 1 for solvents that are known to cause unacceptable risk, Class 2 for solvents with less severe toxicity and Class 3 for the least toxic solvents.
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