2.3 · eCTD
QOS Composer & Dossier
Quality Overall Summary and cross-checks across every section.
- Finds inconsistencies between sections
- Shows missing Module 3 sections
- eCTD folder zip
Follows Module 2.3 · eCTD v3.2.2
Solutions / Dossier and review
Write the QOS, review any CMC section, and keep the GMP reports in step.
The QOS Composer builds Module 2.3 from the other modules and finds facts that disagree between sections. The Report Reviewer checks any report or section, wherever it was written. Post-approval changes and the GMP quality reports are here too: process and cleaning validation, investigations, change control and the annual product review.
Modules
Quality Overall Summary, regional sections, IND/IMPD and post-approval filings
3.2.R · Module 1
Regional Information
US and EU regional information and the CMC items of Module 1.
- Executed batch records, method validation package, 356h sites
- Categorical exclusion (EIC) and EU ERA (PECsw) calculated
- EEA batch release, QP declaration, Article 117 device opinion
Follows 3.2.R · 21 CFR 25 · EMEA/CHMP/SWP/4447/00
IND · IMPD
IND & IMPD Quality
Phase-appropriate CMC for an IND or an EU IMPD.
- Clinical impurities compared with the tox batch
- Tests expected for the phase and dosage form
- EU shelf-life extrapolation rule
Follows 21 CFR 312.23(a)(7) · EMA/CHMP/QWP/545525/2017
DMF · ASMF
DMF & ASMF
US drug master file and EU active substance master file, with letters of access.
- Applicant's and restricted parts checked
- Same version on both parts
- Annual update and customer letters
Follows 21 CFR 314.420 · CHMP/QWP/227/02 Rev. 4
Any section
Report Reviewer
Upload any CMC section or report and get a list of what is missing.
- Checks against the section checklist
- Tells you what to add and why
- Optional AI review
Follows Module 3 · 2.3 · lab reports
After approval
Post-approval Change Classifier
Sorts each planned change into the US filing type and the EU variation type.
- Annual report, CBE-0, CBE-30 or PAS
- EU Type IA, IAIN, IB or II with the code
- Sections to update and data to provide
Follows ICH Q12 · 21 CFR 314.70 · 601.12 · 2013/C 223/01
AR · CBE · variations
Post-approval Filings
US annual report CMC section, supplements, and EU variation present/proposed tables.
- Annual report due date from the approval anniversary
- Type IA timing and IB/II before approval flagged
- Present, proposed, conditions and documentation
Follows 21 CFR 314.70 · 314.81 · Regulation 1234/2008
GMP quality reports
PPQ, cleaning validation, OOS and APR: the GMP reports behind the dossier
Process and cleaning validation, investigations, change control and the annual product review. Each one checks your data against its predefined criteria and the GMP rules for the US, the EU or both.
OOS · CAPA
OOS, Deviation and CAPA
Structured investigations from first lab check to CAPA effectiveness.
- Phase I and Phase II OOS workflow
- Root cause analysis and impact on other batches
- CAPA plan and effectiveness check
Follows 21 CFR 211.192 · FDA OOS guidance (2022) · ICH Q10
PPQ · CPV
Process Validation Report
Stage 2 PPQ report from your batch data, with the stage 3 verification plan.
- Every result against its predefined criterion
- Ppk per attribute and within-batch spread
- Process parameter excursions flagged
Follows FDA PV guidance (2011) · EU GMP Annex 15
Cleaning · HBEL
Cleaning Validation Report
Cleaning validation report with limits from the health-based exposure limit.
- MACO, swab and rinse limits from the PDE
- Recovery applied to every result
- Runs, hold times and worst case checked
Follows EU GMP Annex 15 · EMA HBEL · 21 CFR 211.67
GMP change
Change Control
Change control record with impact assessment, risk score and regulatory route.
- Impact across quality, validation, methods and systems
- Flags a registered change with no filing
- Actions, owners and effectiveness check
Follows ICH Q10 · Q9(R1) · EU GMP Chapter 1
APR · PQR
Annual Product Review
US annual product review and EU product quality review in one report.
- Ppk and trend rules for each attribute
- OOS, deviations, complaints and recalls counted
- Every 211.180(e) and EU GMP 1.10 item checked
Follows 21 CFR 211.180(e) · EU GMP 1.10 · ICH Q10
S.2.5 · P.3.5
Hold Time Study Report
Maximum hold times for intermediates and bulk, from your time-point data.
- Longest time with every result passing
- Proposed vs supported hold time
- Change from initial and microbiological checks
Follows WHO TRS 992 Annex 4 · EU GMP Annex 15 · 21 CFR 211.111
GMP · Annex 15
Equipment Qualification Report
IQ, OQ and PQ report traced to the user requirements.
- Every test against its acceptance criterion
- Requirements traceability matrix
- Deviations, calibration and data-integrity checks
Follows EU GMP Annex 15 · 21 CFR 211.63/211.68 · ASTM E2500
GMP · Annex 1
Media Fill (APS) Report
Aseptic process simulation report with run-by-run acceptance.
- EU zero-contamination and FDA run-size criteria
- Interventions, duration and incubation checked
- Initial (3 runs) or periodic requalification
Follows EU GMP Annex 1 (2022) · FDA aseptic processing (2004)
GMP · GDP
Shipping Validation Report
Qualification of shipping lanes and containers from logger data.
- Lane × season × load coverage
- Excursions against the stability budget
- Freeze protection and product testing
Follows EU GDP 9.2 · WHO TRS 961 Annex 9 · USP <1079>
GMP · ICH Q10
Technology Transfer Report
Site-to-site transfer with process, batch and analytical comparison.
- Transfer package items tracked to completion
- Process differences justified
- Receiving-site batches against the sending-site range
Follows ICH Q10 · WHO TRS 1044 Annex 4
GMP · Annex 1
Environmental Monitoring Trend Report
Periodic EM trend report by grade, with alert and action levels.
- Annex 1 action limits by grade and sample type
- Recovery rates, organisms and repeat locations
- Excursions and investigations
Follows EU GMP Annex 1 (2022) · USP <1116>
GMP · Annex 16
Batch Record Review & Release
Batch record review, CoA check and release or QP certification.
- Every result against the specification
- Review checklist and deviations
- US QU release and EU QP certification
Follows EU GMP Annex 16 · 21 CFR 211.22, 211.192
GMP · ICH Q7/Q10
Supplier Qualification Report
Risk-based supplier qualification with audit, CoA verification and agreement.
- Risk rating and audit outcome
- Findings with CAPA status
- Quality agreement and requalification date
Follows ICH Q7 · ICH Q10 · EU GMP Chapter 5 · 21 CFR 211.84
ICH Q9(R1)
Quality Risk Assessment (FMEA)
FMEA with RPN before and after actions and a Pareto chart.
- RPN and severity thresholds
- Actions, owners and residual risk
- Pareto chart of failure modes
Follows ICH Q9(R1)
The QOS
A Quality Overall Summary (Module 2.3) that agrees with Module 3
Each module saves a small summary file with your data. The QOS Composer reads all of them, writes Module 2.3, lists the Module 3 sections that are still missing, and puts your files into the eCTD folder structure.
Post-approval changes under ICH Q12
The Change Classifier sorts planned changes by ICH Q12, 21 CFR 314.70 and the EU variations regulation.
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.