ICH Q7 – API GMP Compliance

Pure. Proven. Protected.

ICH Q7 – API GMP Compliance with V5

V5 from SG Systems Global makes ICH Q7 executable on the floor. Not guidance on a shelf—hard-gated behavior in real production. With connected MES, QMS, and WMS, V5 enforces API GMP requirements for materials management, in-process controls, validated operations, cleaning verification, equipment status, labeling, and release—with sealed electronic records and tamper-evident audit trails. Deviations generate quality events, holds propagate across inventory, and only approved documents and label revisions are available at the line. That’s what “controlled” looks like when an inspector asks where the evidence lives.

If you run intermediates and APIs in Pharmaceutical Manufacturing, supply components to Medical Devices or Dietary Supplements, or operate adjacent chemistries like Agricultural Chemical and Plastic & Resin, V5 gives you the same backbone: identity/quality at intake, validated process execution, in-process verification, segregation, status labeling, and forward/backward genealogy. It’s API GMP—digitized and enforced.

“Pure. Proven. Protected. V5 turned our API GMP plan into locked gates—materials, equipment, and people couldn’t bypass requirements. Our MHRA inspection went straight to the evidence.”
— Head of Quality, EU API Manufacturer

How V5 Maps to ICH Q7 Expectations

ICH Q7 is pragmatic: define and validate the process, control what matters, record what happened, and protect the product. V5 operationalizes those fundamentals across materials, equipment, procedures, and people—tying them into a single, defendable execution record. Articles like Electronic Batch Record Systems, eBMR, and BMR vs. MMR vs. eBR vs. eDHR show how those records come together in practice.

Materials & Supplier Control: Approved vendors, COA capture, quarantine, and status labels enforced in WMS with scan-based issue. See sector examples in Pharma and Ingredients & Dry Mixes.
Validated Process Execution: Step logic, parameters, timers, and witnesses in MES—captured to eBMR with device identity and calibration-at-time-of-use proof.
In-Process Controls: Pass/fail checks (pH, conductivity, temperature, sieve/filtration, visual inspection) block progression until acceptance criteria are met; deviations auto-generate quality events in QMS.
Cleaning & Segregation: Line clearance, equipment cleaning status, and area zoning captured against the batch, with optional photo evidence and dual witnesses where SOPs require.
Labeling & Status: Template control, version discipline, and print logs ensure what’s on the container matches the master data; outbound verification stops mismatched shipments (see Global Batch Traceability).

Materials: Identity, Quality, and Status That Can’t Be Skipped

Most API problems start with materials—mis-identified, expired, wrong grade, or released without COA verification. V5 WMS removes luck from the equation. At receiving, operators verify PO, supplier status, and COA; lots are quarantined until released by QA. Putaway is zoned; FEFO is enforced; allergen/hazard segregation (for mixed-mode sites) is hard-gated. When it’s time to issue, barcode checks prevent wrong-lot additions; on-hold material simply won’t scan to the order. If you run solvents or restricted chemicals, location rules and transport labels are part of the same process record (see Ag-Chem).

COA capture & checks: COA image and key attributes stored with the lot; failures route supplier CAPA in QMS.
Scan-enforced issue: Line picks validate item, lot, and quantity; substitutes require approved change control.
Serialization & ship blocks: Pallet/case IDs tied to order/customer; outbound verification blocks mis-ships (see Global Batch Traceability).

Process Execution & eBMR: Prove What Happened, As It Happened

ICH Q7 expects controlled execution and contemporaneous records. In V5 MES, each critical step is executable logic with setpoints, limits, witnesses, device checks, and timers. Readings (e.g., temperature profiles, pH, conductivity, torque) are captured with device identity and calibration status, then sealed to the eBMR. If a limit is breached, the batch holds; QA is pinged; rechecks and reasons are documented. No “we’ll tidy the paperwork later.”

Device attribution: Every reading carries the instrument ID and its verification at time of use.
Review by exception: Green batches clear quickly; QA focus goes to risk and deviations (see EBR Systems).
MMR & version control: Only effective master data (BOM, parameters, labels) can be used—enforced by QMS change control.

For teams comparing formats across sectors, see BMR vs. MMR vs. eBR vs. eDHR and this primer on Batch Manufacturing Records.

Cleaning, Cross-Contamination, and Changeover

For APIs, cleanliness isn’t housekeeping—it’s patient protection. V5 bakes cleaning verification and line clearance into the recipe: operators must complete configured checklists, confirm status labels, record inspection results (with optional photos), and capture dual witness sign-off where required. For shared equipment, differential cleaning procedures are enforced by product class; when the procedure changes, “read & acknowledge” is required before anyone can run it. Mixed-mode sites (e.g., Ingredients & Dry Mixes plus Consumer Products) can document zoning and material compatibility in the same system—one evidence trail.

Pre-op checks: Digitally verified line readiness before batch start; failed checks = batch hold.
Status labels that matter: Clean/dirty/under-maintenance recorded to equipment; blocked at runtime if not correct.
Changeover gates: Confirm removal, cleaning, inspection, and label logic before new product starts.

People, Training & Authorization—Gates, Not Guidelines

Competence is not a spreadsheet field—it’s a runtime decision. V5 QMS ties training requirements to roles, areas, and tasks; if aseptic, sampling, or hazardous-handling qualifications expire, access is denied. Supervisors and QA approvers are bound by the same rules. When SOPs or master data change, impacted users must “read & acknowledge” before executing. At audit time: who signed, their qualification status at that moment, and the procedure revision they followed is one click.

Matrix enforcement: Role → competency → permission. Expired training = blocked step.
4-eyes where needed: Dual witness/approver enforced for high-risk tasks and key identity checks.
Audit pack: Exportable training proofs and sign-off histories aligned to specific eBMR records.

Label Governance & Shipment—What Leaves the Gate Is Proven

Label errors in API handling cause expensive rework and risk. V5 treats labeling as a controlled manufacturing step. Templates and code rules are approved in QMS; in MES, only the correct version is selectable for the active product/SKU; and every print event is logged with operator, time, line, and batch context. At dispatch, outbound verification in WMS blocks shipments that don’t match order/customer, protecting customers and release status.

Template control: Approved labels only; revision history and effective dating maintained.
Print logs: Complete chain: who printed what, when, on which line, for which batch.
Proof chain: “What was printed” ties to “what shipped” in Global Batch Traceability.

For packaging-heavy operations, see examples in Consumer Products and Medical Devices—the same governance applies to API intermediates and finished goods going downstream.

Deviation → CAPA → Change—A Closed Loop the Inspector Can Follow

ICH Q7 expects structured reaction, not ad-hoc fixes. When a limit fails in MES, V5 opens a deviation in QMS; containment holds/blocks propagate to WMS; root cause (Ishikawa, 5-Whys) and CAPA tasks (with owners/dates) are recorded; and effectiveness checks are scheduled. If a procedure or parameter must change, change control enforces impact assessment, approvals, effective dates, and training prerequisites—only the new version is available at the line. Evidence of reduction in recurrence is visible in trend dashboards (see Global Batch Traceability metrics).

Immediate containment: Batch holds and inventory quarantine are automatic and visible.
Supplier CAPA: Intake failures route to supplier tasks and blocks further receipts until resolved.
Effectiveness checks: Scheduled, documented, and trended—no “closed on paper” CAPAs.

Performance: Live, Drillable, Defensible

Management review shouldn’t be a backward-looking PDF pack. V5 exposes live KPIs: deviation density, CAPA aging, first-pass yield, right-first-time, batch cycle time, internal audit status, supplier defect trends, and release lead time. Drill from the KPI to the exact batch, step, operator, reading, and device (with verification at time of use). That’s how you move from anecdotes to action—and why inspectors stop asking speculative questions.

SPC & trending: Capability by product, vessel/line, and shift; review-by-exception removes noise.
Supplier scorecards: COA fails, on-time delivery, defect paretos—linked to supplier CAPAs.
Audit trail analytics: Who changed what and why; outlier patterns stand out before audits.

For context on end-to-end trace, explore Global Batch Traceability and practical comparisons in BMR vs. MMR vs. eBR vs. eDHR.

Adjacent Requirements: When APIs Feed Other Regimes

API plants rarely live in a vacuum. Many supply intermediates to finished-dose facilities under 21 CFR 210/211, or provide actives to device-drug combos. V5 uses the same enforcement model across industries, keeping your records coherent as materials flow downstream. See Pharma, Medical Devices, and even Supplements for how eBMR/eDHR discipline carries across operations.

Mixed-mode sites: Use zoning, equipment status, and work-center rules to separate API, device, and consumer lines.
Label/claims protection: Label governance and print logs keep downstream customers aligned to the right revision (see Consumer Products).
Process validation trail: How you validated becomes part of how you run—inspectors see the thread in EBR Systems and eBMR evidence.

Integration, Validation & Scale

Quality breaks when systems are islands. V5 connects execution, quality, inventory, and ERP through V5 Connect (API) so orders, specs, results, labels, and genealogy flow without re-typing. Deploy on-prem or cloud, single site or multi-site, with validation artifacts aligned to GAMP thinking (see GAMP 5 Software Validation). As you scale, you reuse the same enforced rules; local exceptions are controlled changes—not tribal knowledge.

ERP & devices: Integrate LIMS, balances, coders, printers, PLCs—capturing pass/fail and measurements directly into the batch record.
Validation-ready: Configuration specs, IQ/OQ-style documentation, and UAT templates reduce validation drag.
Multi-site rollout: Copy core models; adjust via change control; retain one evidence style across the network.

Want to see what a disciplined execution record looks like in practice? Start with Electronic Batch Record Systems and the eBMR explainer.

What Inspectors Will See with V5

Instant genealogy: Forward/back trace, rework paths, and mass-balance where relevant—visible in Global Batch Traceability.
Proved controls: CCP/IPC checks, cleaning verification, equipment status labels, and status at time-of-use.
Data integrity: Immutable audit trails, attributable e-signatures, access control, and reason codes.
Competence proof: Who signed, their training status at that moment, and the procedure revision followed.
CAPA effectiveness: Trend reductions, recurrence checks, and linked change records in QMS.

Modules That Power ICH Q7 with V5

MES – Enforced, parameterized steps with device attribution, timers, witnesses, and e-signatures (eBMR).
QMS – Deviations→CAPA, change control, training matrix, document control, internal audits.
WMS – Supplier status, intake inspections, FEFO/expiry, zoning, quarantine, serialization, and ship verification.
V5 Connect (API) – ERP/LIMS/devices integration for a single source of truth.

Bottom line: ICH Q7 isn’t a narrative—it’s a set of behaviors. V5 builds those behaviors into daily work so you don’t “prepare for audits”; you run to standard and let the system prove it. Pure. Proven. Protected.

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