Modules
CMC authoring tools for every part of the dossier, and the GMP reports behind it.
Every module with the CTD sections it writes and the guidance it follows, then the Module 3 map. Switch the map between small molecule and biologic to see which module writes each section.
Solutions
Start from your product type
Small molecule
Chemical drug substances and products, from route of synthesis to Q1E shelf life.
Explore small moleculeBiologics
Proteins and antibodies: cell banks, Q6B characterisation, viral safety, Q5C.
Explore biologicsDossier and review
The QOS, a reviewer for any section, post-approval changes, and GMP reports from PPQ to the APR.
Explore the dossier toolsQuality and validation
Projects, versions, a chained audit trail and the IQ/OQ validation pack.
Explore validationIndex
Which CTD section or report each module writes
| Writes | Module | Follows |
|---|---|---|
| Small molecule | ||
| S.1 · P.1 | Composition & General Info | S.1 · S.3.1 · P.1 |
| S.2 · P.3 | Process & Controls Writer | ICH Q11 · S.2 · P.3 |
| P.2 | Development Studio | ICH Q8(R2) · Q9 · P.2 |
| S.4 · P.5 | Specification Builder | ICH Q6A · Q3A · Q3B · Q3C |
| S.3.2 · P.5.5 | Impurity & Risk Studio | ICH M7 · Q3D · FDA nitrosamine guidance |
| S.7 · P.8 | Stability Studio | ICH Q1A(R2) · Q1E |
| Biologics | ||
| S.2 | Biologics Process Writer | ICH Q5B · Q5D · Q5E · Q11 · S.2 |
| S.3 · S.4 · P.5 | Biologics Characterisation & Specification | ICH Q6B · S.3 · S.4 · P.5 · S.5 |
| A.2 | Viral Safety Studio | ICH Q5A(R2) · Q5D · 3.2.A.2 |
| P.2 · P.3 | Biologics Drug Product Writer | P.1 · P.2 · P.3 · Annex 1 |
| S.7 · P.8 | Biologics Stability Studio | ICH Q5C · Q1E · S.7 · P.8 |
| S.2.6 · ICH Q5E | Biologics Comparability | ICH Q5E · EMEA/CHMP/BMWP/101695/2006 |
| 3.2.R · similarity | Biosimilar Analytical Similarity | FDA CAA guidance (2019) · EMA/CHMP/BWP/247713/2012 |
| ATMP · 3.2.P.5 | Cell & Gene Therapy CMC | FDA gene therapy CMC (2020) · EU GMP Part IV · Ph. Eur. 5.14 |
| Used for both | ||
| S.4.4 · P.5.4 | Batch Analysis & CoA | S.4.4 · P.5.4 · S.5 · P.6 |
| S.6 · P.7 | Container Closure & E&L | S.6 · P.7 · P.2.4 |
| P.4 · A.3 | Excipients Writer | P.4 · 3.2.A.3 · Ph. Eur. 5.15 |
| A.1 | Facilities & Equipment Writer | 3.2.A.1 · EU GMP Annex 1 · 21 CFR 211 |
| S.4.3 · P.5.3 | Method Validation Studio | ICH Q2(R2) · Q14 · USP <1225> |
| S.4.3 · P.5.3 | Method Transfer Report | USP <1224> · EU GMP 6.37–6.41 |
| S.5 · P.6 | Reference Standard Qualification | ICH Q7 11.17–11.19 · USP <11> · Ph. Eur. 5.12 |
| S.3.2 · S.7 · P.8 | Forced Degradation & Photostability | ICH Q1A(R2) · Q1B · Q2(R2) |
| P.2.2 | Dissolution Profile Comparison | FDA SUPAC-IR · EMA BE guideline · ICH M9 |
| P.2.5 | Preservative Efficacy Test Report | USP <51> · Ph. Eur. 5.1.3 |
| GMP quality reports | ||
| OOS · CAPA | OOS, Deviation and CAPA | 21 CFR 211.192 · FDA OOS guidance (2022) · ICH Q10 |
| PPQ · CPV | Process Validation Report | FDA PV guidance (2011) · EU GMP Annex 15 |
| Cleaning · HBEL | Cleaning Validation Report | EU GMP Annex 15 · EMA HBEL · 21 CFR 211.67 |
| GMP change | Change Control | ICH Q10 · Q9(R1) · EU GMP Chapter 1 |
| APR · PQR | Annual Product Review | 21 CFR 211.180(e) · EU GMP 1.10 · ICH Q10 |
| S.2.5 · P.3.5 | Hold Time Study Report | WHO TRS 992 Annex 4 · EU GMP Annex 15 · 21 CFR 211.111 |
| GMP · Annex 15 | Equipment Qualification Report | EU GMP Annex 15 · 21 CFR 211.63/211.68 · ASTM E2500 |
| GMP · Annex 1 | Media Fill (APS) Report | EU GMP Annex 1 (2022) · FDA aseptic processing (2004) |
| GMP · GDP | Shipping Validation Report | EU GDP 9.2 · WHO TRS 961 Annex 9 · USP <1079> |
| GMP · ICH Q10 | Technology Transfer Report | ICH Q10 · WHO TRS 1044 Annex 4 |
| GMP · Annex 1 | Environmental Monitoring Trend Report | EU GMP Annex 1 (2022) · USP <1116> |
| GMP · Annex 16 | Batch Record Review & Release | EU GMP Annex 16 · 21 CFR 211.22, 211.192 |
| GMP · ICH Q7/Q10 | Supplier Qualification Report | ICH Q7 · ICH Q10 · EU GMP Chapter 5 · 21 CFR 211.84 |
| ICH Q9(R1) | Quality Risk Assessment (FMEA) | ICH Q9(R1) |
| Dossier and review | ||
| 2.3 · eCTD | QOS Composer & Dossier | Module 2.3 · eCTD v3.2.2 |
| 3.2.R · Module 1 | Regional Information | 3.2.R · 21 CFR 25 · EMEA/CHMP/SWP/4447/00 |
| IND · IMPD | IND & IMPD Quality | 21 CFR 312.23(a)(7) · EMA/CHMP/QWP/545525/2017 |
| DMF · ASMF | DMF & ASMF | 21 CFR 314.420 · CHMP/QWP/227/02 Rev. 4 |
| Any section | Report Reviewer | Module 3 · 2.3 · lab reports |
| After approval | Post-approval Change Classifier | ICH Q12 · 21 CFR 314.70 · 601.12 · 2013/C 223/01 |
| AR · CBE · variations | Post-approval Filings | 21 CFR 314.70 · 314.81 · Regulation 1234/2008 |
Module 3 map
The CTD Module 3 map: which module writes each section
Drug substance
3.2.S
S.1General informationComposition & General InfoS.2Manufacture, route, starting materialsProcess & Controls WriterS.2Manufacture, cell banks, process validation, comparabilityBiologics Process WriterS.3Structure and impuritiesComposition · Impurity & Risk StudioS.3Characterisation (Q6B) and impuritiesBiologics CharacterisationS.4Specification and justificationSpecification BuilderS.4Specification with potency and K/M endotoxinBiologics CharacterisationS.4.2–4.3Procedures and validationMethod Validation StudioS.4.4 · S.5Batch analyses, reference standardsBatch Analysis & CoAS.6Container closureContainer Closure & E&LS.7StabilityStability StudioS.7Stability by Q5C: potency, aggregates, freeze-thawBiologics Stability Studio
Drug product
3.2.P
P.1Description and compositionComposition & General InfoP.2Pharmaceutical developmentDevelopment StudioP.3Manufacture, batch formula, flow diagramProcess & Controls WriterP.2 · P.3Formulation, fill-finish, media fills, devicesBiologics Drug Product WriterP.4Control of excipients, animal origin, novel excipientsExcipients WriterP.5Specification, procedures, batchesSpecification Builder · Batch AnalysisP.5Specification with particles, sterility, potencyBiologics CharacterisationP.7Container closure and E&LContainer Closure & E&LP.8Stability and commitmentsStability StudioP.8Stability, in-use and shipping studiesBiologics Stability Studio
Appendices and regional
3.2.A · 3.2.R
A.1Facilities, cleanroom grades, cleaning limitsFacilities & Equipment WriterA.2TSE/BSE statement for excipientsReport Reviewer checks itA.2Viral safety: Q5A(R2) clearance and retrovirus marginViral Safety StudioA.3Novel excipients: full data setExcipients WriterR · USExecuted batch records, method validation packageQOS ComposerR · EUProcess validation scheme, CEP/ASMF, deviceQOS Composer
Summary and checks
Module 2.3 · any report
2.3Quality Overall Summary from every tool's summary fileQOS ComposerZipeCTD folder structure with all sectionsQOS ComposerCheckUpload any section, PDF or scan and see what is missingReport ReviewerReportsStability, validation, OOS, deviation, CAPAStudiosChangesPost-approval changes: US supplement or EU variation typeChange Classifier
Sections in amber use the biologics rules: ICH Q5A(R2), Q5B, Q5C, Q5D, Q5E and Q6B.
Sections in amber use the biologics rules: ICH Q5A(R2), Q5B, Q5C, Q5D, Q5E and Q6B.
Judge it on a section you already wrote
Paste a section into the Report Reviewer and read what it finds. Nothing you paste leaves your computer.