TITLE 21
READY-TO-GO CMC SERIES
GENERIC DRUG DEVELOPMENT CMC KNOW-HOW LIST
Contents of a Ready-To-Go CMC Dossier
| Contents | CMC- Chemistry
Manufacturing and Control Database TOC of a Typical Solid Oral Dosage Form CMC Dossier |
| 1 | Active Material Specifications (bulk density - particle size) |
| 2 | Master Manufacturing Formula - Commercial batch lots - Presented in detailed FDA-type Format |
| 3 |
Detailed Manufacturing & Process Instructions - in FDA Format |
| 4 | In-Process Quality Control |
| 5 | Processing Equipment Speeds, Times - All settings and parameters |
| 6 | Coating Formulation and Specification- All settings and parameters |
| 7 | In-process Specifications |
| 8 | Final Product Specifications |
| 9 | Stability Check Specifications |
| 10 | Certificate of Analysis per Strength |
| 11 | Comparison to US Reference Drug |
| 12 | Dissolution Test & Parameters |
| 13 | Comparative Dissolution Profile |
| 14 | Hardness Vs Dissolution Qualification |
| 15 | Uniformity of Weight Qualification |
| 16 | Stability Protocol |
| 17 | Stability Profile |
| 18 | Stability Data & Results |
| 19 | Post Stability - Dissolution Profile |
| 20 | Dissolution Data & Results |
| 21 | Validated Analytical Assay |
| 22 | Stability Indicating Assay |
| 23 | Assay Validation |
| 24 | Impurity Profile |
| 26 | Process Validation Protocol |
| 26 | Process Validation Report |
| 27* | Outline and Summary of Bioequivalent Study Report |
| 28 | Additional Data Specific to Dosage Form or Active Material |
*(where available)
- CMC may have additional data where appropriate
e.g. comparative studies against the Reference Listed Drug
[List 1] [List 2] [List
3][List 4][List 5]
