Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.
These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality, purity, or potency, as these factors are critical to the safety or effectiveness of the drug. Changes are classified into major, moderate, and minor categories, each with distinct reporting requirements to the FDA. Major changes have a substantial potential to affect the drug product adversely. An example is a move to a different manufacturing site. These changes necessitate a Prior Approval Supplement, requiring FDA approval before distribution. Moderate changes, such as changes in the manufacturing process, have a moderate potential for adverse effects. These changes require a supplement—changes being effected in 30 days—where distribution can occur when the FDA receives the supplement. Minor changes, like changing an existing code imprint for a dosage form from numeric to alphanumeric, have minimal potential for adverse effects. These changes must be reported in the manufacturer's next annual report. In all instances, manufacturers should assess the effects of the change before distributing a drug product made with a manufacturing change.
Post-approval, manufacturers may alter the new or generic product.
Such changes can include altering the active pharmaceutical ingredient, manufacturing process or site, formulation, batch size, and container closure system.
These changes must be evaluated for their impact on the drug’s identity, strength, quality, purity, potency, safety, and efficacy, before modified product distribution.
The FDA classifies these changes as major, moderate, and minor, each having varying impact on the product.
Major changes, like manufacturing site relocation, substantially impact drug safety or effectiveness and require FDA approval before drug product distribution.
Moderate changes, like a modification in the manufacturing process, moderately impact drugs. These changes require either submitting the supplement to the FDA thirty days before distribution or distribution upon the FDA’s receipt of the supplement.
Minor changes like updating existing code imprints for dosage forms have minimal influence on the drug product. However, these changes must be reported in the manufacturer's next annual report.
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