Process Performance Qualification (PPQ) – Proving the Process at Intended Scale

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

Updated October 2025 • Lifecycle Validation & Commercial Readiness • QA, Manufacturing, Engineering

Process Performance Qualification (PPQ) is the decisive demonstration that your commercial process—run by trained people, on qualified equipment, with controlled materials—can deliver conforming product consistently at intended scale. PPQ sits within the modern lifecycle: the process is defined in design, its controls are proven functionally during equipment IQ/OQ/PQ, and then PPQ shows that the integrated manufacturing system actually works with real variability across lots, operators, and shifts. After that, CPV keeps watch. A credible PPQ uses the live MES/eBMR, enforces material identity and movement via the WMS, and confirms quality decisions in LIMS—because the only defensible proof is the same evidence you’ll rely on tomorrow.

“PPQ is not theater. If your PPQ run doesn’t look like next Tuesday’s production, it isn’t proof—it’s a rehearsal with different lines.”

1) What PPQ Proves—and Where It Sits in the Lifecycle

PPQ is the bridge between development claims and commercial reality. It proves that the configured and qualified system can repeatedly hit targets with the real noise of supply, environment, and people. In the lifecycle view, process design defines the control strategy, equipment IQ/OQ/PQ verifies functional readiness, PPQ demonstrates at-scale performance, and CPV sustains capability with ongoing data and SPC. PPQ is not a paperwork gate; it’s the first time your process has to prove it can defend itself under inspection, day after day.

2) Preconditions: Equipment, Methods, People, and Records

PPQ demands a steady platform. Equipment must have completed IQ/OQ and, where appropriate, equipment-level PQ; calibration windows and maintenance are enforced via Asset Calibration Status. Analytical methods used for acceptance are validated and governed in LIMS, with calculations implemented under CSV. Procedures, label templates, and specifications are effective-dated under Document Control. People are trained, roles and e-signature meanings align to Part 11/Annex 11, and all records (including Audit Trails) are retained per Data Retention & Archival. If any of these anchors wobble, the PPQ result is just a lucky day.

3) Designing the PPQ Protocol—Risk-Based and Defensible

A strong PPQ protocol reads like a contract with your future self. It lists the products, scales, lines, and formats covered; the MMR/MBR versions; and critical parameters with their rationales. It defines acceptance criteria for process capability and product quality, lays out sampling plans and locations, and explains how Deviations/NCs will be handled. Crucially, it specifies which interlocks and alarms must fire—and be captured in the eBMR. For labeling and traceability, challenge Label Verification and scan-backs to prove the “right item, right lot” controls work under pressure. The protocol should tie each test and measurement back to risk and intended use so auditors see design logic, not superstition.

4) Sampling Plans, MSA, and Statistical Expectations

Capability conclusions are only as strong as the measurements behind them. Start with MSA to verify that instruments, methods, and human reads can discriminate within tolerated error. Then define sampling that represents the process across time and space: beginning/middle/end pulls, across cavities or lanes, across tanks and totes, and across shifts and operators. Use SPC Control Limits for in-process parameters where trending matters; treat finished attributes with capability indexes and defect metrics. The protocol should describe exactly how OOT will be identified during PPQ, not just after, so the team knows what triggers investigation before a spec breaks into OOS.

5) Materials, Identity, and Movement—No Right-Process/Wrong-Lot

Most PPQs fail quietly through identity mistakes. Control inbound via the WMS with Directed Picking and Bin Location Management, and enforce FIFO/FEFO to remove human judgment from shelf-life decisions. Quarantine until Hold/Release is satisfied. At kitting and addition, scan-and-verify with Barcode Validation inside the MES. PPQ must demonstrate that if an operator reaches for the wrong lot, the system prevents it—and that the eBMR keeps the evidence of the prevented error.

6) Executing PPQ in the MES/eBMR—Make Truth Frictionless

Run PPQ exactly as you will run production. Effective-dated MMR/MBR control the sequence, limits, and signatures. Device links (balances for gravimetric weighing, vision systems for machine vision) record raw readings with timestamps and user attribution. In-Process Controls (IPC) fire SPC alerts as designed; interlocks block or require dual verification before progressing. The eBMR should read like a forensic narrative: who, what, when, where, why—plus attached labels, scans, and audit trail extracts. If your PPQ evidence lives in side spreadsheets, you’re proving a different system than the one you’ll actually run.

7) Laboratory Confirmation—Methods, LIMS, and Data Integrity

Where PPQ requires laboratory confirmation, results and decisions belong to LIMS. Methods, specifications, and calculations are versioned and validated under CSV; instruments are in-status via Asset Calibration Status; chromatographic results (e.g., HPLC) are linked with run IDs and operator context. Review flows capture Audit Trail events, and outliers follow the staged OOS pathway. The goal is simple: PPQ lab data must be indistinguishable in structure and integrity from routine release testing.

8) Data Integrity—E-Signatures, Audit Trails, and Retention

PPQ proves the process; data integrity proves the proof. Enforce unique users and e-sign meanings per Part 11; maintain immutable, time-synchronized Audit Trails across MES, LIMS, and WMS; and store evidence per Data Retention & Archival. In PPQ, include negative tests: attempt to progress with expired lots, attempt edits on critical fields without reason codes, disconnect a device mid-weigh—then show the system’s blocks and audit entries. If your records can be rewritten, your validation can be rewritten—regulators won’t buy it.

9) Handling Signals—Deviations, OOT, and OOS without Drama

PPQ is not a “no-issues” fantasy. It is a realistic trial of your controls. When IPC triggers or results drift into OOT, the system should open a Deviation/NC with clear scope and impact. If a specification fails, follow the OOS path—Phase 1 integrity checks, then hypothesis-driven retests where justified. Root causes lead to CAPA and are implemented via MOC. What matters in PPQ is transparency: all results (good and bad) remain in the record; all overrides and waivers are visible; and the final conclusion weighs the totality of evidence, not the most favorable rerun.

10) Release Logic—From PPQ Batches to Routine Lots

Some organizations restrict PPQ batches from market release until criteria are met; others release if predefined conditions are satisfied. Either way, your logic should be explicit in the protocol and enforced by systems. QA disposition is posted through Lot Release; WMS shipment should be impossible until that disposition exists. Where certificates are used, the eBMR and LIMS results support the Finished-Goods Release. If PPQ proves capability but your warehouse can ship without QA approval, your “validated state” fails at the last mile.

11) Documentation—What a Defensible PPQ Package Looks Like

A PPQ package should reconstruct the story without interpretation. It includes: process design summary and risk assessment; references to equipment IQ/OQ/PQ; the PPQ protocol with acceptance criteria; executed eBMRs; LIMS results with method/spec versions; labeling controls and Label Verification evidence; investigations (Deviations/NC, OOT/OOS); statistics (capability, yields, defect rates); and the final conclusion with any CAPA/MOC actions. Store the lot under Document Control so auditors can drill down to the exact timestamped screen that proves a stop or signature occurred.

12) Common PPQ Failure Modes—and the Antidotes

• Happy-path PPQ. Antidote: write fail-intent tests into the protocol (expired lot, wrong label, out-of-tolerance add) and prove interlocks stop the process.
• Shadow spreadsheets. Antidote: implement calculations in MES/LIMS under CSV; treat exports as read-only evidence.
• Drifting masters. Antidote: effective-dated MMR/MBR, specs, and label templates under Document Control; strict release to production.
• Weak measurement systems. Antidote: run MSA before capability claims; otherwise your chart is fiction.
• Equipment suitability assumed. Antidote: enforce Asset Calibration Status checks and lockouts; show the block in evidence.
• Release before disposition. Antidote: hard-stop shipments in WMS until Lot Release is posted.
• Label mismatches. Antidote: govern templates and run online Label Verification with scan-back to master.
• Protocol that doesn’t match reality. Antidote: author with the system owner; dry-run steps; remove ceremonial steps that operators will never perform in production.

13) Metrics that Demonstrate Readiness

Prove that PPQ wasn’t luck. Track: first-pass yield across PPQ runs; deviation density; proportion of fail-intent tests executed and blocked; time-to-QA disposition; percentage of IPC signals addressed within takt; labeling non-read rate; identity-block events at kitting; and capability indices for critical attributes. After launch, connect PPQ rigor to outcomes: fewer NCRs, shorter disposition cycles (Lot Release), and improved service measures like order-to-ship lead time. If the numbers don’t move, the process wasn’t truly proven—or the controls aren’t truly used.

14) How This Fits with V5 by SG Systems Global

V5 Solution Overview. The V5 platform treats PPQ as production with the training wheels off. Configuration is versioned; evidence is attributable; and cross-module interlocks—identity, equipment status, signatures, and label checks—are first-class, making PPQ defensible and repeatable.

V5 MES. In the V5 MES, PPQ runs use the same effective MMR/MBR that drive routine batches. Sequencing, tolerances, device captures (e.g., gravimetric weighing), and IPC/SPC stops are enforced and recorded in the eBMR with e-signatures and Audit Trails.

V5 QMS. Within the V5 QMS, Document Control, Change Control, and MOC govern protocols, deviations, CAPA, and requalification triggers. Periodic reviews use the same data created by production, not curated copies.

V5 WMS. The V5 WMS enforces receiving, quarantine, Directed Picking, bin/location rules, and shelf-life logic (FIFO/FEFO); pack-line Label Verification and QA disposition gates shipment.

Bottom line: V5 makes PPQ indistinguishable from compliant production: same masters, same interlocks, same evidence—so the capability you prove is the capability you keep.

15) FAQ

Q1. How many PPQ runs are needed?
Enough to represent intended variability—materials, equipment, shifts, and operators—and to support statistical confidence backed by MSA and trended with SPC. The count is justified in the protocol, not guessed.

Q2. Can we use development batches as PPQ?
Only if they were executed with commercial masters (MMR/MBR), on qualified equipment with production interlocks, and under full data integrity controls. Otherwise, they’re prior knowledge—not PPQ.

Q3. What triggers re-PPQ or supplemental PPQ?
Significant changes to process, materials, equipment, software interlocks, label templates, or site; recurring OOT/OOS; or negative trends in CPV—assessed via MOC and routed through Change Control.

Q4. How does PPQ interact with data integrity requirements?
PPQ must be executed with unique users, e-sign meanings per Part 11, immutable Audit Trails, validated calculations (CSV), and governed storage via Data Retention & Archival—the same way routine will run.

Q5. How do we connect PPQ to CPV?
Use PPQ findings to choose CPV metrics and limits. Embed SPC in the live process, trend through CPV, and feed actions into CAPA with implementation under MOC.

Related Reading
• Lifecycle & Capability: CPV | MSA | SPC Control Limits
• Equipment & Records: Equipment Qualification (IQ/OQ/PQ) | IQ | OQ | Audit Trail (GxP) | Data Retention & Archival
• Systems & Execution: MES | LIMS | WMS | eBMR
• Governance & Actions: Document Control | Change Control | MOC | Deviation / Nonconformance | OOT | OOS | CAPA