Dissolution Testing Program Checklist (USP <711>)

Method Development and Validation

Establish a discriminating method.

• Is the dissolution method developed to be discriminating for relevant formulation and process changes? *
• Are media, volume, and sink conditions selected and justified for the drug solubility? *
• Is the method validated for specificity, linearity, accuracy, and precision? *
• Select the dissolution apparatus type used.

Apparatus Qualification

• Is the dissolution apparatus mechanically qualified for parameters such as shaft wobble, vessel centering, and rotation speed? *
• Is performance verification testing (PVT) or an enhanced mechanical calibration performed at the required frequency? *
• Are media temperature (typically 37 +/- 0.5 C) and deaeration controlled? *

Acceptance Criteria and Testing

• Are staged acceptance criteria (S1, S2, S3) applied for the tolerance (Q value)? *
• Is the Q value and time point established and included in the release specification? *
• Record the specified Q value (%) for the product.

Data Review and Investigation

• Are dissolution results reviewed by the quality unit and any failures investigated? *
• Are profile comparisons (e.g., f2 similarity factor) used to support changes where applicable?