Qualified Person (QP) Release – EU GMP Certification

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Pharmaceutical Batch Certification & Disposition • QA, Manufacturing, Regulatory

A Qualified Person (QP) is the EU‑mandated professional who certifies each medicinal product batch before it is released to market or further supply. QP certification is not a rubber stamp or a clerical step; it is a formal declaration that the batch was manufactured and tested in accordance with the Marketing Authorisation/IMPD, that facilities and equipment were under GMP control, that critical deviations are resolved, that sampling and testing demonstrate conformity, and that traceability and data integrity are complete from raw materials to finished goods. After certification, the organization proceeds to formal disposition in Lot Release / QA Disposition, enabling Finished Goods Release and shipment.

“QP release is the highest‑stakes signature in pharma: one signature, backed by evidence, that proves the entire system worked.”

1) What QP Release Covers—and What It Does Not

Covers: The QP ensures the batch complies with approved specifications, methods, and the Marketing Authorisation, that manufacturing was controlled under GxP, that critical changes followed MOC, that deviations were investigated and closed with appropriate CAPA, that starting materials and components met release requirements (Component Release), and that storage and distribution conditions support product quality (GDP).

Does not cover: The QP is not a substitute for robust system operation. QP certification cannot compensate for weak Document Control, missing raw data, or unvalidated systems. Nor does the QP perform every investigation personally—the QP evaluates the sufficiency and evidence of those investigations to decide whether release is defensible.

2) QP Release: Legal, System, and Data Integrity Anchors

QP certification rests on a fully controlled quality system. Electronic records must meet Part 11 and Annex 11 expectations, with validated software under CSV, attributed to unique users, and protected by immutable audit trails. Manufacturing and testing equipment must be in status (calibration, maintenance) and qualified per IQ/OQ/PQ. Procedural documents live in Document Control, and the pharmaceutical quality system aligns with ICH Q10. These anchors ensure the QP signs against trustworthy, reconstructable evidence.

3) The Evidence Pack for QP Certification

The QP examines a structured dossier—digital where possible—covering:

• eBMR and MBR/MMR lineage: The executed eBMR must trace to the effective MBR/MMR with controlled versioning and signatures.
• Material identity & status: Each input’s identity and status (released, quarantined, rejected) with scan‑based pedigree in Lot Traceability.
• Sampling & testing: Sampling plans, LIMS results, calculations, HPLC chromatograms, and ELN reasoning; OOS/OOT handled per SOP.
• Equipment & facilities: Calibration/maintenance status (Asset Calibration Status), cleaning status (Cleaning Validation), and relevant EM results.
• Deviations & CAPA: Linked Deviations/NCs, NCRs/NCMRs, MRB outcomes, and implemented CAPA.
• Validation state: Product/process validation (PV, PPQ), method validation/verification, and ongoing control via CPV/SPC limits.
• Labels & pack: Artwork/version, variable data, and scan checks per Labeling Control and Label Verification.
• Certificates & release: Supplier CoA reconciliation, and final QA disposition in Lot Release.

The QP’s judgment weighs the totality—not one perfect number but a coherent story from controlled instructions to compliant product ready for patients.

4) From Batch Completion to QP Certification—A Standard Path

1) Batch closes in MES. The MES finalizes execution; the eBMR assembles scans, entries, limits, and signatures tied to the effective MBR/MMR.
2) QA Review. QA confirms data integrity, verifies audit trails, checks deviations/OOS are closed, and ensures Document Control versions align.
3) QP assessment. The QP reviews the compiled evidence, asks clarifying questions, and determines whether certification criteria are fully met.
4) Certification & disposition. The QP certifies the batch; QA executes disposition in Lot Release; WMS inventory moves from Quarantine/Hold to shippable stock for Finished Goods Release.

If any step fails, the batch remains blocked until remediations—under MOC and CAPA—are verified and re‑reviewed.

5) Handling OOS, OOT, and Deviations Before Release

Nothing derails a certification like unresolved signals. OOS results trigger forensics from data integrity checks through hypothesis testing and MRB disposition; OOT trends challenge capability and may justify tightened controls before the next batch. Deviations with product impact require documented root cause and risk assessment. The QP does not need perfection; the QP needs proven cause, appropriate impact bounds, and implemented, effective CAPA where warranted.

6) Contract Manufacturing, Importation & Oversight

QP responsibility extends along the supply chain. For third‑country manufacturing, the QP must ensure equivalent GMP oversight and that shipped batches maintain identity and conditions (e.g., temperature) under GDP. Documentation flows—CoAs, batch summaries, stability commitments—must be verified against the importing site’s quality system. Where serialization applies, the QP should confirm the integrity of serialized identities and aggregation trees (Serialization, GTIN and, if relevant, SSCC on logistics units) from pack to pallet.

7) Data Integrity—Proving the Proof

The eBMR, LIMS results, and WMS records must tell a consistent story. That means ALCOA(+) principles via Data Integrity, with audit trails that capture who/what/when/why, e‑signatures bound to real users per Part 11/Annex 11, and validated integrations under CSV. The QP must be able to reconstruct critical events (e.g., a rework step, a hold lift) by reading records—not by interviewing operators after the fact.

8) Sampling, Methods, and Laboratory Controls

Sampling and testing underpin certification. The QP should see evidence that sampling plans were justified and followed, methods validated or verified, and calculations correct. Chromatographic data (e.g., HPLC) should include system suitability and integration rules; LIMS and ELN records should show peer review and second‑person verification where required. Where PAT is used, demonstrate that models are validated, monitored, and version‑controlled under Document Control.

9) Facilities, Equipment & Cleaning Status

Before certification, the QP verifies that equipment was fit for use (calibration and maintenance current), utilities met specs, and cleaning status supported product integrity. Link these checks to qualification records, pre‑use checks in the eBMR, Cleaning Validation holds, and relevant Environmental Monitoring excursions. If an asset was out‑of‑tolerance mid‑run, the investigation must bound impact and justify fate of the batch (retest, rework, or reject).

10) Packaging, Labeling & Serialized Identity

Mislabeling is a critical risk. The QP examines how labels were controlled and verified: template version, variable data (lot, expiry), and barcodes validated at pack per Label Verification. If serial numbers are used, the QP should confirm correct commissioning, aggregation, and any decommission/rework events in the packaging record, with product identifiers aligned to GTIN and logistics units labeled with SSCC for downstream traceability in the WMS.

11) Warehouse Status, Holds & Distribution Readiness

QP certification is only meaningful if the physical stock is controlled. The QP checks that finished goods are under Quarantine/Hold until disposition, that WMS statuses prevent premature picks, and that expiry and storage conditions (FEFO vs. FIFO) are enforced. After certification and Lot Release, the system must flip inventory to shippable and feed compliant labels and documents into Pack & Ship flows without manual workarounds.

12) Validation Lifecycle—PV, PPQ, and CPV

The QP signs against a validated state. That requires demonstrable Process Validation (including PPQ), method validation/verification, and ongoing CPV with SPC control limits. If CPV signals drift (e.g., towards an OOT boundary), the QP may still certify a conforming batch but should demand heightened oversight and timely CAPA to protect future consistency.

13) Metrics That Demonstrate QP Control

• Time to Certification: median days from eBMR completion to QP sign‑off—shortened by clean data and integrated systems.
• Rework/Block Rate: percent of batches blocked at QP step due to unresolved deviations or documentation gaps.
• OOS/OOT Closure Time: cycle time from detection to QP‑acceptable closure.
• Audit‑Ready Completeness: percentage of certification packs that pass internal Internal Audit without finding.
• Release Holds Avoided: holds prevented by early signal capture (e.g., PAT or MES interlocks).
• APR Linkage: degree to which QP findings flow into APR and drive improvements.

These KPIs build confidence that certification is both rigorous and efficient, and that lessons learned feed back into the system.

14) Common Pitfalls & How to Avoid Them

• eBMR gaps and post‑hoc edits. Avoid by enforcing role‑based entries, contemporaneous recording, and audit trails that block raw‑data overwrites.
• Unclear deviation impact. Require standardized product impact assessments and MRB documentation tied to discrete lots via genealogy.
• Method or equipment out of validated state. Track version and qualification status in the eBMR; block steps if assets are overdue (calibration status checks).
• Label/pack mismatches. Use verification at pack; treat mismatches as deviations not operator fixes.
• Weak integration across MES/LIMS/WMS. Validate interfaces under CSV; reconcile item/lot identities with scanner‑based checks end‑to‑end.
• QP as last‑minute gatekeeper. Involve the QP perspective earlier through batch review checkpoints, reducing end‑stage surprises and delays.

15) What Goes in the QP Certification Record

The certification record should identify the batch and product, reference the MBR/MMR and eBMR IDs, list major linked records (deviations, OOS/OOT, MRB, CAPA), confirm validation and equipment status, and state any post‑release commitments (e.g., stability trending). It must include the QP’s name, qualification, date/time, and a statement of certification. Ideally, this is generated from the same system that governs execution so cross‑references are clickable and immutable under Document Control.

16) How This Fits with V5 by SG Systems Global

V5 Solution Overview. The V5 platform is built to make QP certification defendable and fast. Configuration is versioned, evidence is attributable, and cross‑module interlocks (identity, status, signatures) are testable and reportable—ideal for GMP and life‑cycle control.

V5 MES. The V5 MES drives right‑first‑time execution: effective‑dated MBR/MMR, device integrations, in‑process limits, and eBMR with audit trails. Batch review by exception highlights QP‑relevant gaps before final close.

V5 QMS. Within the V5 QMS, deviations, OOS, MRB, CAPA, and MOC are orchestrated under Document Control, yielding a complete certification dossier without spreadsheet patchwork.

V5 WMS. The V5 WMS enforces status discipline (Quarantine, Hold, Released), aligns labels with item/lot identity (Label Verification, GTIN, SSCC), and prevents picks until QA disposition flips stock to shippable.

Bottom line: V5 turns QP certification from a manual chase into a click‑through narrative—every control you prove during operation becomes evidence the QP can sign with confidence.

17) FAQ

Q1. Does the QP personally review every raw datum?
No. The QP relies on validated systems and independent QA reviews. However, the QP must be able to access and understand raw data, audit trails, and investigation summaries when needed, and must be satisfied that controls assure data integrity.

Q2. Can a batch with a closed deviation be certified?
Yes, if the deviation’s root cause and product impact are fully understood, corrective actions are implemented, and risk is acceptably mitigated. The QP’s judgment—supported by MRB records and CAPA status—determines whether certification remains defensible.

Q3. How does serialization affect QP release?
The QP should verify correct commissioning, aggregation, and reconciliation of serial numbers (Serialization) and alignment of product identifiers (GTIN) and logistics labels (SSCC) to prevent downstream traceability gaps.

Q4. What happens if EM or cleaning status is out at time of manufacture?
Impact assessment is required. If product risk cannot be bounded or is unacceptable, the QP should not certify the batch. Where risk is bounded and mitigated, the QP may certify with documented rationale—often alongside CAPA and enhanced monitoring.

Q5. Is QP certification the same as Lot Release?
No. QP certification is the regulatory attestation under EU GMP. Lot Release is the internal QA disposition step that updates inventory status and triggers Finished Goods Release. Certification is necessary; disposition executes the operational change of state.

Q6. How are QP certifications audited?
Inspectors trace the certification back to the eBMR, deviations/OOS, validation, and labeling controls, checking that records are attributable, contemporaneous, and immutable. Internal audits and APR trending prepare organizations for this scrutiny.

Related Reading
• Core GMP & Systems: GMP | ICH Q10 | Annex 11 | 21 CFR Part 11 | CSV | Document Control
• Execution & Records: MES | eBMR | LIMS | ELN | Audit Trail | Data Integrity
• Decisions & Disposition: Lot Release | Finished Goods Release | MRB | CAPA | MOC
• Validation & Control: Process Validation | PPQ | CPV | SPC Control Limits
• Packaging & Traceability: Label Verification | GS1 GTIN | SSCC | Serialization