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TITLE 21
READY-TO-GO CMC SERIES

GENERIC DRUG DEVELOPMENT CMC KNOW-HOW

Contents of a Ready-To-Go CMC Dossier

Contents Title 21 CMC- Chemistry Manufacturing and Control Database
TOC of a Typical Solid Oral Dosage Form CMC Dossier
1 Active Material Specifications (bulk density - particle size when relevant)
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 Controls
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 Comparisons 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 (if not USP)
24 Impurity Profile
26 Process Validation Protocol
26 Process Validation Report(s)
27* Outline and Summary of Bioequivalent Study Reports (if not restricted)
28 Additional Data Specific to Dosage Form or Active Material

*(Where data /development 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]

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