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Use case · CTD Module 3 · Quality

Module 3, drafted from the batch record up.

Asthra consolidates BMRs, CoAs, specifications, validation reports, and stability data into structured CTD Module 3 narratives — drug substance and drug product. Every spec value, every method, every justification cites the source.

✦ CTD Module 3 progress
Project · drug-substance v2
3.2.SDrug Substance
3.2.S.1General informationDone
3.2.S.2ManufactureDone
3.2.S.3CharacterisationDone
3.2.S.4Control of drug substanceDrafting
3.2.S.5Reference standardsSpec gap
3.2.S.6Container closurePending
3.2.S.7StabilityPending
3.2.PDrug Product
3.2.P.1Description & compositionDone
3.2.P.2Pharmaceutical developmentDrafting
3.2.S+P
Full drug-substance and drug-product modules drafted to ICH M4Q.
~4×
Faster section-drafting cycle versus manual authoring in pilot CMC teams.
Cell-level
Citations for every specification value — to BMR, CoA, or method record.
Inputs

Manufacturing-floor evidence, indexed.

BMR

Batch manufacturing records

Process steps, parameters, in-process controls. Asthra extracts the procedural narrative for §3.2.S.2 and §3.2.P.3.

CoA

Certificates of analysis

Release results across batches. Asthra reconciles spec values against acceptance criteria with cell-level citations.

DOC

Method validation reports

HPLC, GC, dissolution, microbiological methods. Feed §3.2.S.4.3 and §3.2.P.5.3 with method summaries.

XLS

Stability data

Long-term, accelerated, and intermediate-condition data. Asthra constructs stability tables with statistical context preserved.

DOC

Specifications

Drug-substance and drug-product spec docs with justification trail. Mapped section-by-section into §3.2.S.4.1 / §3.2.P.5.1.

PDF

Prior submissions

For continuity with previously approved markets — keeps Module 3 narratives consistent across regulatory filings.

Workflow

From batch to filing.

01

Load the quality dossier

BMRs, CoAs, methods, specs, stability — Asthra ingests, classifies by CTD section, and surfaces any missing documents before drafting.

02

Approve the section map

Asthra proposes which document supports each Module 3 subsection. CMC SMEs swap in newer batches, exclude legacy data, and confirm the source set.

03

Draft Module 3 narratives

§3.2.S.1 through §3.2.P.8 drafted to ICH M4Q. Asthra constructs spec-comparison tables, manufacturing-step descriptions, and stability-data summaries with cell-level citations.

04

SME review & reconciliation

Quality, manufacturing, and analytical reviewers refine sections in Word — chat with Asthra to swap a method, integrate a new batch, or align with a prior submission.

05

Hand off to publishing

Final Module 3 sections ship to the publishing team in eCTD-ready form, with the audit ledger embedded — ready for FDA, EMA, or PMDA filing.

Manual vs. Asthra

What changes for the CMC writing team.

Manual Module 3 drafting

  • −12–20 weeks for full Module 3 first draft
  • −Spec-table assembly across batches: weeks of analyst time
  • −Method narratives rewritten for every filing region
  • −Stability data reconciled by hand against shelf-life claims
  • −Cross-section consistency depends on writer memory

Module 3 drafting with Asthra

  • +First draft in weeks; review parallelizes across SMEs
  • +Spec tables auto-generated from CoAs with cell-level provenance
  • +Method narratives reuse validated content across regions
  • +Stability claims tied to the underlying data points
  • +Citation graph keeps cross-section data consistent automatically

Pilot Asthra
on a real Module 3.

30-day pilot. One product, one region. We benchmark Asthra's draft against your existing process — batch record to eCTD.

Start a pilot →How Asthra works