Training
Training guides
A step-by-step guide for every CMCfy module. Each one walks through the built-in example, explains every field, the checks and alerts, the preview and gap review, US and EU differences, common pitfalls, and ends with practice exercises. Every guide is also a PDF for your training records.
How every module works
- Open a module. Each opens with example data loaded, so you can see a finished result before entering anything. The bar under the title counts every network request the page makes; it stays at 0 because your data never leaves your computer. Download offline copy saves a single file that opens from your own computer with all network access blocked, for air-gapped PCs.
- Enter your data. Replace the example panel by panel. Tables take rows pasted from Excel, or press Load file for Excel, CSV, Word, PDF or a scanned page (text is read on your computer). Choose the Submission region: US, EU or both.
- Read the result and resolve alerts. Numbers and pass/fail come from fixed rules. Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record. Major alerts block the download until you fix them or type a justification and press Accept justification. Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
- Check the narrative. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.
- Preview, review and download. Every document opens in a preview with a review of gaps in the data, gaps in the report and differences from your protocol; then download Word or PDF.
- Bring it together. Download summary for QOS saves a small file that the QOS Composer & Dossier Assembler reads to write Module 2.3 and check that the sections agree. Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.
Module 3 sections
Composition & General Info
Write nomenclature, structure, general properties, structure elucidation and the drug product composition, with molecular weight, CAS number, elemental analysis, salt factor and unit weight checked by calculation.
3.2.S.1.1 · 3.2.S.1.2 · 3.2.S.1.3 · 3.2.S.3.1 · 3.2.P.1
Process & Controls Writer
Turn your process steps into the manufacture sections: manufacturers, batch formula, process description with a flow diagram, controls of critical steps and intermediates, and process validation.
3.2.S.2.1 · 3.2.S.2.2 · 3.2.S.2.3 · 3.2.S.2.4 · 3.2.S.2.5 · 3.2.P.3.1 · 3.2.P.3.2 · 3.2.P.3.3
Development Studio
Write pharmaceutical development (3.2.P.2) or drug substance process development (3.2.S.2.6) from your QTPP, critical quality attributes, FMEA risk assessment and studies.
3.2.P.2.1 · 3.2.P.2.2 · 3.2.P.2.3 · 3.2.P.2.5 · 3.2.P.2.6 · 3.2.S.2.6
Specification Builder
Set tests and acceptance criteria, check them against ICH Q6A and the impurity thresholds for your maximum daily dose, and write the specification, analytical procedures, justification and excipient sections.
3.2.S.4.1 · 3.2.S.4.2 · 3.2.S.4.5 · 3.2.P.4 · 3.2.P.5.1 · 3.2.P.5.2 · 3.2.P.5.6
Batch Analysis & CoA
Check every batch result against the specification, write the batch analysis and reference standard sections, and produce a certificate of analysis for any batch.
3.2.S.4.4 · 3.2.P.5.4 · 3.2.S.5 · 3.2.P.6
Impurity & Risk Studio
Assess organic, mutagenic (ICH M7), nitrosamine and elemental (ICH Q3D) impurities, with limits computed from your dose, duration and route, and write each as its CTD section and a standalone report.
3.2.S.3.2 · 3.2.P.5.5
Container Closure & E&L
Describe the container closure system and show it is suitable: protection, compatibility, safety and performance, with compendial tests, light and moisture protection, leachable thresholds and container closure integrity checked by rule.
3.2.S.6 · 3.2.P.7 · 3.2.P.2.4
Excipients Writer
Write the control of excipients: specifications and procedures for non-compendial excipients, justification, excipients of human or animal origin, and the full data set for a novel excipient (3.2.A.3).
3.2.P.4.1 · 3.2.P.4.2 · 3.2.P.4.3 · 3.2.P.4.4 · 3.2.P.4.5 · 3.2.P.4.6 · 3.2.A.3
Facilities & Equipment Writer
Describe the facility for 3.2.A.1: room classifications and pressure cascade, flows, shared and dedicated equipment, and cleaning validation with limits calculated from the PDE of each product on shared equipment.
3.2.A.1
Biologics
Biologics Process Writer
Write drug substance manufacture for a biotechnology product: sites, upstream and downstream process with a flow diagram, cell banks and raw materials, critical steps and hold times, process validation and comparability.
3.2.S.2.1 · 3.2.S.2.2 · 3.2.S.2.3 · 3.2.S.2.4 · 3.2.S.2.5 · 3.2.S.2.6
Biologics Characterisation & Specification
Write characterisation, impurities, specification and justification, and reference standards for a protein or antibody, with impurity levels per dose and the endotoxin limit calculated from the dose.
3.2.S.3.1 · 3.2.S.3.2 · 3.2.S.4.1 · 3.2.S.4.5 · 3.2.P.5.1 · 3.2.P.5.6 · 3.2.S.5
Viral Safety Studio
Write the adventitious agents safety evaluation (3.2.A.2): viral clearance totalled per model virus by ICH Q5A(R2) rules and the retrovirus safety margin calculated from particles, titre, yield and dose.
3.2.A.2
Biologics Drug Product Writer
Write the drug product sections for a protein injectable: composition, formulation development, fill volume and overfill, compatibility, devices, the fill-finish process with a flow diagram, and sterility assurance.
3.2.P.1 · 3.2.P.2 · 3.2.P.3.2 · 3.2.P.3.3 · 3.2.P.3.4 · 3.2.P.3.5
Biologics Stability Studio
Write the stability sections for a protein product: each stability-indicating attribute trended by ICH Q1E regression, the shelf life limited to the real-time data as ICH Q5C expects, and the supporting studies checked.
3.2.S.7.1 · 3.2.S.7.2 · 3.2.S.7.3 · 3.2.P.8.1 · 3.2.P.8.2 · 3.2.P.8.3
Biologics Comparability (ICH Q5E)
Write the ICH Q5E comparability report for a manufacturing change: each quality attribute of the post-change batches compared with a range from the pre-change batches, the stability comparison, and the impact of any difference.
3.2.S.2.6 · 3.2.R · Report
Biosimilar Analytical Similarity
Write the comparative analytical assessment of a proposed biosimilar against its reference product: quality ranges from the reference lots, the share of biosimilar lots inside them, profile comparisons, and the residual uncertainty.
3.2.R · 3.2.S.3.1 · Report
Cell & Gene Therapy CMC
Write the CMC control section for a cell or gene therapy: the release panel and lot results, starting and ancillary materials, potency, replication-competent virus testing, chain of identity, stability and shipping.
3.2.S · 3.2.P · 3.2.P.5
Reports behind the sections
Stability Studio
Estimate shelf life from long-term data by ICH Q1E regression with batch poolability testing, and write a stability report with chart, tables, conclusion and the post-approval commitment.
3.2.S.7 · 3.2.P.8 · Stability report
Method Validation Studio
Write a validation protocol, then calculate linearity, accuracy, precision, LOD/LOQ, specificity and robustness from your data and write the validation report against ICH Q2(R2).
3.2.S.4.3 · 3.2.P.5.3 · Validation protocol and report
Investigation Studio (OOS, deviation, CAPA)
Run an out-of-specification, out-of-trend or deviation investigation from the first laboratory check to CAPA and closure, with the rules of the FDA OOS guidance and EU GMP built in.
OOS / OOT report · Deviation report · CAPA plan
Method Transfer Report
Write the analytical method transfer report: the receiving laboratory's results compared with the sending laboratory's against the criteria set in the protocol, with the statistics done for you.
Report · 3.2.S.4.3 · 3.2.P.5.3
Reference Standard Qualification
Qualify a primary or secondary (working) reference standard: identity, purity, the assigned content and the requalification date.
Report · 3.2.S.5 · 3.2.P.6
Forced Degradation & Photostability
Write the forced degradation (stress testing) report and the ICH Q1B confirmatory photostability report, and conclude whether the procedure is stability-indicating and whether the product needs protection from light.
3.2.S.3.2 · 3.2.S.7 · 3.2.P.5.5 · 3.2.P.8
Dissolution Profile Comparison
Compare the dissolution profiles of a test and a reference batch with the f2 similarity factor, for a change, an additional strength or a BCS-based biowaiver.
3.2.P.2.2 · Report
Preservative Efficacy Test Report
Write the antimicrobial effectiveness test report: log reductions for each organism checked against USP <51> for the product category and Ph. Eur. 5.1.3 criterion A or B.
3.2.P.2.5 · Report
GMP quality reports
Process Validation Report
Write the stage 2 process performance qualification (PPQ) report from your batch data: every result against its predefined criterion, capability (Ppk) per attribute, process parameters against their ranges, deviations, and the stage 3 continued process verification plan.
Report · 3.2.P.3.5 · 3.2.S.2.5
Cleaning Validation Report
Write the cleaning validation report with acceptance limits calculated from the health-based exposure limit (PDE) of the product cleaned, and every swab, rinse, visual, TOC, bioburden and endotoxin result checked against its limit with recovery applied.
Report · 3.2.A.1
Change Control
Write the GMP change control record: the change and its reason, current and proposed states, an impact assessment across ten areas, a risk score, the US and EU regulatory route, actions with owners and dates, and the effectiveness check.
Report
Annual Product Review
Write the US annual product review (21 CFR 211.180(e)) or the EU product quality review (EU GMP 1.10), or both in one report: batches and yields, capability and trend rules for each critical attribute, quality events by type, and every review item the regulations name.
Report
Hold Time Study Report
Establish the maximum hold times for intermediates, bulk product and process pools from your time-point data, and compare them with the hold times you propose for the batch record.
3.2.S.2.5 · 3.2.P.3.5 · Report
Equipment Qualification Report
Write the IQ, OQ and PQ report for a piece of equipment or a utility, with every test traced to the user requirements and a conclusion on release for GMP use.
GMP · 3.2.A.1
Media Fill (APS) Report
Write the aseptic process simulation report: units filled, incubated and contaminated in each run, the interventions simulated and the outcome against EU Annex 1 and the FDA aseptic processing guidance.
GMP · 3.2.P.3.5 · 3.2.A.1
Shipping Validation Report
Qualify shipping lanes and containers from logger data: summer and winter profiles, minimum and maximum loads, and excursions against the stability budget.
GMP · 3.2.P.3.5 · 3.2.P.8
Technology Transfer Report
Write the site-to-site technology transfer report: the transfer package, process and equipment differences, receiving-site batches against the sending-site range, and the filings for the site change.
GMP · 3.2.P.3 · 3.2.S.2
Environmental Monitoring Trend Report
Write the periodic environmental monitoring trend report: results by grade and sample type against Annex 1 action limits and your alert levels, recovery rates, organisms and adverse trends.
GMP · 3.2.A.1
Batch Record Review & Release
Document the batch record review and the release decision: every result against the specification, the review checklist, deviations, and US quality unit release or EU QP certification.
GMP
Supplier Qualification Report
Write the supplier qualification report: risk rating, audit outcome and findings, quality agreement, CoA verification by in-house testing and the requalification date.
GMP · 3.2.S.2.3 · 3.2.P.4
Quality Risk Assessment (FMEA)
Write a quality risk assessment by FMEA: severity, occurrence and detection for each failure mode, the RPN before and after actions, residual risk and a Pareto chart.
GMP · 3.2.P.2 · 3.2.S.2.6
Dossier assembly and review
QOS Composer & Dossier Assembler
Bring the summary files from every module together: write the Quality Overall Summary (Module 2.3) and 3.2.R, check that the same facts agree across sections, see which Module 3 sections are still missing, and build the eCTD folder.
2.3 · 3.2.R
Report Reviewer
Upload any CMC section or report written anywhere and get a list of what a reviewer would find missing, with the guidance that asks for it and what to add.
3.2.S · 3.2.P · 3.2.A · 3.2.R · 2.3 · OOS, validation, stability, nitrosamine and Q3D reports
Post-approval Change Classifier
List your planned CMC changes and get the suggested US reporting category and EU variation type for each, with the CTD sections to update and the data to provide, taking ICH Q12 established conditions and approved protocols into account.
Report
Regional Information (3.2.R and Module 1)
Write the US and EU regional information (3.2.R) and the CMC items of Module 1: the manufacturing establishments, the environmental assessment or categorical exclusion, the EU environmental risk assessment, the manufacturers in the application form and the QP declaration.
3.2.R · Module 1
IND & IMPD Quality
Write the quality part of an IND or an EU investigational medicinal product dossier (IMPD), appropriate to the phase: drug substance and drug product summaries, impurities compared with the toxicology batch, the specification, and a shelf life that covers the trial.
IND/IMPD 2.1.S · IND/IMPD 2.1.P
Post-approval Filings
Write the CMC section of the US annual report and the supplement summaries, and the EU variation present/proposed tables, from one list of implemented and planned changes.
Report
DMF & ASMF
Prepare a US drug master file or an EU active substance master file: allocate each section to the applicant's or restricted part, check the versions, the annual update and the letters of access.
Report · 3.2.S