FDA Provides Guidelines for Allowed Post-Market Changes to Drug Manufacturing Processes

The FDA has announced the availability of a draft guidance for industry titled “Postapproval Changes to Drug Substances,” that is applicable to holders of approved new drug applications, abbreviated new drug applications (ANDAs), new animal drug applications, abbreviated new animal drug applications and holders of drug master files and veterinary master files.

The guidance discusses how the risk of one or more changes to the drug substance manufacturing process during the drug product application postapproval period should be assessed. It also provides recommendations regarding the documentation needed to support the changes for the drug substance or for the drug product made with a modified drug substance.

The details in the guidance document cover facility, scale and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, raw materials, intermediates and the unfinished and final drug substance; synthetic manufacturing process changes; changes in the source of drug substance; and a change to the container closure system of the drug substance.

The FDA committed to issuing a guidance on postapproval changes to active pharmaceutical ingredient drug master files (DMFs), also known as Type II DMFs, and submission mechanisms for ANDA holders who reference these DMFs, as part of the reauthorization of the Generic Drug User Fee Amendments (GDUFA II).

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