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

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