Stage of Testing
- CU is tested on finished dosage forms (tablets/capsules).
- BU is tested on the powder blend before these forms are made.
Purpose
- CU ensures the patient receives the intended dose.
- BU ensures the manufacturing process starts with a uniform API distribution.
Testing Process
- CU involves testing individual tablets or capsules.
- BU involves sampling multiple locations of the powder blend.
Impact of Failure
- CU Failure: Could result in batch rejection or recalls.
- BU Failure: Indicates potential segregation or poor mixing, leading to downstream CU issues.
Why Both Matter?
- A uniform blend doesn’t guarantee uniform content in tablets or capsules. Segregation, poor flow, or die-filling issues can lead to CU failures.
- Similarly, perfect CU in dosage forms cannot exist without a uniform blend.
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