What are the two general situations that would alter the quality or performance of a solid dosage form and would also require FDA approval?

The two general situations that would alter the quality or performance of a solid dosage form and would also require FDA approval are:

1. Changes in the formulation: If there are any changes in the active ingredients or excipients used in the formulation of the solid dosage form, it could potentially alter the quality or performance of the drug. This includes changes in the type or quantity of the ingredients. Such changes would require FDA approval as they could affect the safety, efficacy, or bioavailability of the drug.

2. Changes in the manufacturing process: Any changes in the manufacturing process of the solid dosage form could also alter its quality or performance. This includes changes in the method of production, the equipment used, the site of manufacture, or the scale of production. These changes would also require FDA approval as they could affect the consistency, stability, or bioequivalence of the drug.

In both cases, the manufacturer would need to provide the FDA with data demonstrating that the changes do not adversely affect the drug's safety, efficacy, or quality. This could involve conducting additional studies or tests.