Acetriptan Tablets, 20 mg, a generic version of the reference listed drug (RLD), Brand Acetriptan Tablets, 20 mg.

The RLD is an immediate release (IR) tablet indicated for the relief of moderate to severe physiological symptoms.

Use Quality by Design (QbD) to develop generic acetriptan IR tablets that are therapeutically equivalent to the RLD.

The Reference Listed Drug (RLD) is Brand Acetriptan Tablets, 20 mg, and was approved in the United States in 2000 (NDA 211168) for therapeutic relief of moderate to severe symptoms. The RLD is an unscored immediate release (IR) tablet with no cosmetic coating. The tablet needs to be swallowed as is without any intervention. Thus, the proposed generic product will also be an unscored IR tablet with no cosmetic coating. The maximum daily dose in the label is 40 mg (i.e., one tablet twice per day). A single tablet is taken per dose with or without food. Brand Acetriptan Tablets, 20 mg, should be swallowed whole with a glass of water.

Description White round tablet debossed with ACE Batch No. A6970R Expiry date November 2011 Strength (mg) 20 Average weight (mg) 201.2 No Score Uncoated Diameter (mm) 8.02-8.05 Thickness (mm) 2.95-3.08 Volume (mm3) 150.02 average measured using image analysis Hardness (kP) 7.4-10.1 Disintegration time (min) 1.4-1.6 Disintegration observation Rapidly disintegrates into fine powder Assay (% w/w of label claim) 99.7-100.2 Related Compound 1 (RC1) (%) ND Related Compound 2 (RC2) identified as ACE12345 (%) 0.41-0.44 Related Compound 3 (RC3) (%) ND Related Compound 4 (RC4) (%) ND Highest individual unknown (%) 0.07-0.09

1. Provide a summary of the case

2. What is QTPP, the target and justification?

3. What is CQA, the target and justification?

4. What is CMA, the target and justification?

5. What is CPP, the target and justification?

6. Complete FMEA steps. For each failure identified, assign a Risk Priority Number.