Module 3-quality

Module 3: Quality

Module 3 contains the Body of Data for drug substance (S) and drug product (P) quality information, including manufacturing, controls, characterization, and stability per ICH M4Q guidelines.

Module 3 is your CMC data — everything about what the drug is made of and how you make it. Drug substance characterization, manufacturing process, specifications, stability data. It's governed by ICH M4Q (currently being revised to M4Q(R2), effective June 2027).

Start with Drug Substance for your API and Drug Product for the final dosage form. For IND Phase 1, FDA allows abbreviated CMC data — you don't need full commercial-scale validation yet. But you do need enough to show the drug is safe to give to humans.

Regfo maps your CMC documentation against the requirements for each submission phase, so you know what's needed now versus what can wait until your NDA.

Sections

3.2.S — Drug Substance

Drug substance quality information: characterization, manufacture, control, reference standards, stability

26 sub

3.2.P — Drug Product

Drug product quality information: composition, development, manufacture, control, stability

34 sub

3.2.A — Appendices (Quality)

Quality appendices for biotech products: facilities, adventitious agents, novel excipients

3 sub

3.2.R — Regional Information

Region-specific quality information (executed batch records, comparability protocols, methods validation)

3 sub

Related Sections

m1 — Module 1: Administrative Information and Prescribing Information

Module 1 contains documents that are specific to each region. It includes administrative information such as application forms, prescribing information, and labeling. This module is NOT part of the Common Technical Document (CTD) and varies by regulatory region.

m2 — Module 2: Common Technical Document Summaries

Module 2 provides overviews and summaries of Modules 3, 4, and 5. It includes the Quality Overall Summary, Nonclinical Overview, Clinical Overview, and detailed written/tabulated summaries.

m4 — Module 4: Nonclinical Study Reports

Module 4 contains nonclinical study reports organized per ICH M4S: pharmacology (primary, secondary, safety), pharmacokinetics (ADME), and toxicology (general, genetic, carcinogenicity, reproductive).

m5 — Module 5: Clinical Study Reports

Module 5 contains clinical study reports organized per ICH M4E: biopharmaceutic studies, human PK/PD studies, efficacy and safety studies, post-marketing data, and case report forms.

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