CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.2 Pharmaceutical Development

CASE STUDY

QC dissolution method: 250 ml pH 6.8 Phosphate buffer + 4.0% SLS, paddle apparatus, 75 rpm, 37 ° C

Paddle apparatus (II) = 50rpm

Basket apparatus (I) = 100rpm

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

13

3.2.P.2 Pharmaceutical Development

≥10% maximum commercial batch size, or > 100,000 units

Bioequivalence

Not expired

Type of product

Strength

MFD or EXP

Assay

Batch size (capsules)

>5%

Test product

Soft capsules

400 mg

110,000 units

92.4%

MFD 09/2019 EXP 08/2022

110,000 units

99.5%

Reference product

Soft capsules

400 mg

EXP 08/2020

In vitro dissolution in QC dissolution method and 3 pH 1.0-6.8

Similarity of dissolution test-reference products by f2 or similar (Annex 1 BE Guideline)

(commitment) Comparative dissolution profile testing on the first three production batches.

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

14