Pure Monograph Intelligence

ICH Q10 · 15 Sections

Tech Transfer Wizard

Answer the questions below — PureMonograph generates your complete ICH Q10 package

1

Product

2

Sites

3

Manufacturing

4

Analytical

5

Regulatory

6

Confirm

Product identity — FDA/USP standards

INN / non-proprietary name (WHO INN)

Dosage form (FDA CDER — auto-filtered)

Strength (FDA-approved — auto-suggested)

BCS classification (USP <1088> / FDA)

RLD / Reference Listed Drug (FDA Orange Book)

Reason for transfer

Step 1 of 6

Source site GMP certifications

Health Canada GMP Certificate FDA 21 CFR Part 211 (Drug Products) EMA EU GMP Certificate (Annex 1) WHO GMP (prequalification) ICH Q7 GMP for APIs ISO 13485 (device combination product) FDA 21 CFR Part 600 (Biologics License) DSCSA / EU FMD Serialization

Target site GMP certifications

Health Canada GMP Certificate FDA 21 CFR Part 211 EMA EU GMP Certificate (Annex 1) WHO GMP ICH Q7 GMP for APIs ISO 13485 FDA 21 CFR Part 600 (Biologics) DSCSA / EU FMD Serialization

Source batch size

Target batch size

Scale factor (auto-calculated)

Source cleanroom class (ISO)

Target cleanroom class (ISO)

Target site compliance history

Step 2 of 6

Manufacturing — we build the process package from your answers

How this works Select your process type and critical operations. PureMonograph generates the full BMR structure, CPP/CQA matrix, scale-up risk assessment, and equipment qualification requirements using ICH Q8R2, USP, and FDA guidance. You do not need to write any process narrative.

Step 3 of 6

Analytical methods — validated at source site (USP / ICH Q2R2)

Assay — HPLC-UV (USP <621>) Impurities / related substances — HPLC Dissolution — USP <711> / <724> Content uniformity — USP <905> Identification — IR / UV / XRPD Water content — Karl Fischer USP <921> Residual solvents — GC-HS (ICH Q3C) Particle size — laser diffraction USP <429> Microbial limits — USP <61> / <62> Elemental impurities — ICP-MS (ICH Q3D) Sterility — USP <71> Endotoxin / LAL — USP <85> Hardness / friability — USP <1217> Disintegration — USP <701> Chiral purity — chiral HPLC Bioassay — USP <111> (biologics) Protein characterization — SEC / CEX / icIEF Extractables / leachables — ISO 10993

Method transfer protocol

Reference standard source

Known analytical challenges (optional)

Step 4 of 6

Regulatory strategy

Target submission type

Regulatory change category

Target submission date

Target commercial launch date

PPQ batches required

Overall transfer risk level

Low
Standard transfer, same equipment, proven process

Medium
Scale change, equipment differences, or new site

High
Sterile, biological, novel process, or compliance history

Additional sections to include

FMEA risk assessment (ICH Q9) Cleaning validation — MACO (FDA 2024) PPQ protocol (FDA 2011 guidance) Stability bridging plan (ICH Q1A R2) Equipment DQ/IQ/OQ/PQ matrix E&L study plan (USP <1663> / ISO 10993) Bioequivalence / biowaiver strategy GMP training records plan Milestone timeline and Gantt Comparability protocol (ICH Q5E / biologics)

Specific regulatory concerns (optional)

Step 5 of 6

✓

Ready — click Generate Package

PureMonograph will generate your complete 15-section ICH Q10 tech transfer dossier — 3,000–5,000 words with all tables, CPP/CQA matrix, FMEA, cleaning validation, and regulatory strategy. Click any step above to edit.

Package contents confirmed

Step 6 of 6

TT

Tech Transfer Package

Fill in details to build your package

Molecule—

Dosage form—

Strength—

BCS class—

Scale-up—

Regulatory path—

Change type—

Risk level—

15 sections included

✓Pre-transfer assessment

✓Tech transfer protocol

✓BMR & process documentation

✓Analytical method transfer

✓Equipment qualification matrix

✓Raw material qualification

✓PPQ validation protocol

✓Cleaning validation (MACO)

✓Stability bridging plan

✓Regulatory strategy memo

✓FMEA risk assessment

✓Change control plan

✓GMP training records plan

✓Milestone timeline & Gantt

✓Post-transfer monitoring