S.1 · P.1
Composition & General Info
Nomenclature, structure, properties and product composition.
- Formula, MW and salt factor checks
- Unit weight and IID checks
- S.1, S.3.1 and P.1
Follows S.1 · S.3.1 · P.1
Solutions / Small molecule
CTD Module 3 software for small molecule drug substances and products.
From nomenclature and the route of synthesis through specifications, M7 and nitrosamine risk, to shelf life under ICH Q1E. Each module checks your data against the guideline and writes the section for the US, the EU or both.
Written for small molecules
Specifications, impurities, process and stability for chemical drugs
S.2 · P.3
Process & Controls Writer
Manufacture, flow diagram, batch formula and process controls.
- Flow diagram drawn for you
- Batch formula from unit formula
- Starting materials per Q11
Follows ICH Q11 · S.2 · P.3
P.2
Development Studio
Pharmaceutical development with QTPP, CQAs and risk assessment.
- FMEA with risk priority numbers
- DoE ranges and design space
- Excipient compatibility
Follows ICH Q8(R2) · Q9 · P.2
S.4 · P.5
Specification Builder
Drug substance and drug product specifications with justification.
- Q6A tests by dosage form
- Impurity limits checked against Q3A/Q3B
- S.4 and P.5 sections in Word
Follows ICH Q6A · Q3A · Q3B · Q3C
S.3.2 · P.5.5
Impurity & Risk Studio
Characterisation, mutagenic impurities, nitrosamines and elemental impurities.
- M7 class and control option
- Nitrosamine CPCA and AI limits
- Q3D risk by route
Follows ICH M7 · Q3D · FDA nitrosamine guidance
S.7 · P.8
Stability Studio
Shelf-life estimation and stability reports from long-term data.
- Regression per batch and ANCOVA poolability
- 95% confidence bound and extrapolation limits
- Report with chart, tables and conclusion
Follows ICH Q1A(R2) · Q1E
Used for both
Method validation, batch analysis and packaging, shared with biologics
These modules apply to chemical and biological products. They switch their checks with the product type.
S.4.4 · P.5.4
Batch Analysis & CoA
Batch results tables, discussion and certificates of analysis.
- Results checked against the specification
- Reference standard retest dates
- CoA for any batch
Follows S.4.4 · P.5.4 · S.5 · P.6
S.6 · P.7
Container Closure & E&L
Packaging description, suitability and extractables and leachables.
- USP <661.1>, <660>, <381> checks
- SCT and AET calculation
- Container closure integrity
Follows S.6 · P.7 · P.2.4
P.4 · A.3
Excipients Writer
Control of excipients, from compendial grades to a full novel excipient package.
- Pharmacopoeia references checked for the region
- TSE and human or animal origin
- Novel excipient data (3.2.A.3)
Follows P.4 · 3.2.A.3 · Ph. Eur. 5.15
A.1
Facilities & Equipment Writer
Facilities, cleanroom grades and shared equipment for 3.2.A.1.
- EU GMP Annex 1 grades and pressure cascade
- Cleaning limits from PDE (MACO and swab)
- Beta-lactam and high-potency segregation
Follows 3.2.A.1 · EU GMP Annex 1 · 21 CFR 211
S.4.3 · P.5.3
Method Validation Studio
Validation protocols and reports for assay, impurity, dissolution and ID methods.
- Linearity, accuracy, precision, LOD/LOQ
- Protocol review against the guideline
- AI-drafted narrative with number checks
Follows ICH Q2(R2) · Q14 · USP <1225>
S.4.3 · P.5.3
Method Transfer Report
Analytical method transfer between laboratories, with the comparison worked out for you.
- Difference of means and %RSD for each laboratory
- 90% confidence interval of the difference (equivalence)
- Comparative testing, co-validation, revalidation or waiver
Follows USP <1224> · EU GMP 6.37–6.41
S.5 · P.6
Reference Standard Qualification
Qualify a primary or working reference standard and assign its content.
- Identity by orthogonal techniques
- Content by mass balance, confirmed by qNMR
- Secondary standard traced to the primary; requalification date
Follows ICH Q7 11.17–11.19 · USP <11> · Ph. Eur. 5.12
S.3.2 · S.7 · P.8
Forced Degradation & Photostability
Stress testing and ICH Q1B photostability, with the stability-indicating conclusion.
- Degradation and mass balance for each stress
- Peak purity and resolution checked
- Exposed vs dark control in each pack; light-protection statement
Follows ICH Q1A(R2) · Q1B · Q2(R2)
P.2.2
Dissolution Profile Comparison
f2 similarity for changes, additional strengths and BCS biowaivers.
- f2 over the right time points, with CV and unit checks
- Rapid (85% in 15 min) rule applied
- ICH M9 class I and III conditions
Follows FDA SUPAC-IR · EMA BE guideline · ICH M9
P.2.5
Preservative Efficacy Test Report
Antimicrobial effectiveness against USP <51> and Ph. Eur. 5.1.3.
- Log reductions for each organism and time
- USP category and Ph. Eur. criterion A or B
- Tested at the lowest specified preservative level
Follows USP <51> · Ph. Eur. 5.1.3
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.