ICH Q7 · EU GMP Part II · US DMF
API manufacturing software with ICH Q7 records from starting material to release — campaign batches, cleaning validation, DMF/CEP data.
Active Pharmaceutical Ingredient manufacturing under ICH Q7 (Good Manufacturing Practice for APIs) and EU GMP Part II — starting-material qualification, campaign batch records, in-process controls, cleaning validation, impurity and residual-solvent control, and stability — all evidenced as one dataset the DMF and the CEP will actually rest on. Written for API CMOs and integrated pharma tired of stitching campaigns together in Word.
Starting-Material Qualification
Campaign Batch Records
In-Process Controls in-Line
Cleaning validation (MACO / ADE)
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You're shopping because the last MHRA inspection challenged your starting-material designation and cleaning validation limits.
Starting-material designation is a memo, not a controlled record
Campaign batch records are Word documents reconstructed after execution
In-process controls (IPC) live in the QC LIMS, not in the batch record
Cleaning validation limits (MACO, ADE/PDE) are recalculated in Excel every campaign
Impurity and residual-solvent limits aren't tied to the ICH Q3A/Q3C update
DMF Module 3 assembly means pulling from five systems that don't agree
ICH Q7, top to bottom of the API tree.
Starting-Material Qualification
ICH Q7 §7 / §11 — starting-material designation, supplier qualification, specification, retest, and change control. The 'where does GMP start' question has a signed answer.
Campaign Batch Records
Multi-batch campaigns modeled as one production record with per-batch execution — no re-typing the same MBR ten times. IPC results, deviations and yield reconciliation attach to the batch, not the campaign template.
In-Process Controls in-Line
IPC methods, limits, and sampling points execute inside the batch record. LIMS results flow back to the batch — no side-channel Excel.
Cleaning validation (MACO / ADE)
MACO based on ADE/PDE per EMA cleaning-validation guidance. Worst-case product per equipment train recalculated when a new API is introduced — with the change-control trail.
Impurity + Residual-Solvent Control
ICH Q3A (impurities in new APIs), Q3C (residual solvents), Q3D (elemental impurities) limits enforced on release. Updates to the guideline propagate through specifications with an evidenced change.
DMF / CEP Module Assembly
US DMF Type II and EDQM CEP Module 3 sections (3.2.S.2 manufacture, 3.2.S.3 characterisation, 3.2.S.4 control) assemble from live data — not a Word file rewritten each submission.
What changes when ICH Q7 is one live system.
- Starting-material designation is a controlled record inspectors can pull
- Campaign batch records execute in the system, not on paper
- Impurity / residual-solvent spec updates propagate with a change record
- DMF Module 3 assembly drops from weeks to days
- MHRA / FDA inspection findings on documentation drop toward zero
Every framework an API QA director owns.
ICH Q7
Good Manufacturing Practice for Active Pharmaceutical Ingredients — §4 buildings, §5 process equipment, §6 documentation, §7 materials, §8 production, §9 packaging, §10 storage, §11 laboratory, §12 validation, §13 change control, §14 rejection, §15 complaints, §16 contract, §17 agents, §18 APIs by cell culture, §19 clinical APIs.
EU GMP Part II
European GMP Part II adopts ICH Q7 for APIs used as starting materials in medicinal products — inspected by EU competent authorities as the API GMP standard.
ICH Q3A / Q3C / Q3D / Q11
Impurities in new drug substances (Q3A), residual solvents (Q3C), elemental impurities (Q3D), and development / manufacture of drug substances (Q11) modeled as living specifications, not static documents.
21 CFR Part 11
§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.
EU GMP Annex 11
Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — software controls that support your Annex 11 approach; validation and procedures remain yours.
API manufacturing software, answered.
What is API manufacturing software?
API manufacturing software is the GMP platform that runs an Active Pharmaceutical Ingredient producer under ICH Q7 and EU GMP Part II — starting-material qualification, campaign batch records, in-process controls, cleaning validation, impurity control, and release — with the evidence base the US DMF, EU CEP and inspection dossier all rest on. It replaces the Word-MBR-plus-LIMS-plus-Excel combination most API sites inherit.
How does V5 handle the ICH Q7 starting-material question?
Starting-material designation is a controlled record: which chemical or biological material is the 'API starting material' under ICH Q7 §11.1, the justification, the supplier qualification, the specification and the change history. When an inspector asks 'where does GMP start on this synthesis?', there's a signed answer with revision history.
Does V5 support campaign batch records?
Yes. A campaign is modeled as one production plan with N execution batches. The Master Batch Record is authored once and versioned; each batch execution captures its own IPC, deviations, yields and release without re-typing the MBR.
How is cleaning validation handled?
MACO / ADE-PDE calculations run against the current product mix per equipment train.
Can V5 produce DMF / CEP submission content?
Yes. Module 3.2.S sections (S.2 manufacture, S.3 characterisation, S.4 control of drug substance) assemble from live process, specification, batch, stability and validation data. Submission is a curated export, not a document-authoring project from scratch.
How long does implementation take?
Existing paper MBRs migrate through a structured template import.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Run ICH Q7 as one dataset the DMF actually rests on.
Free trial. Real API campaign evidence.