Weighing & DispensingGlossary

Weighing & Dispensing – Component Control

Q: How tight should weigh tolerances be?

Set risk-based tolerances considering process sensitivity, scale capability (MSA/% readability), and TNE guardbanding. Tolerances must be both achievable and meaningful.

Q: When are assay or moisture corrections applied?

When the MBR specifies ‘as‑is’ vs ‘active’ basis. Pull assay/moisture from controlled sources, apply governed formulas, and record inputs and results in the eBMR.

Q: Do I need a second-person verification?

For high-risk components such as APIs or sensitizers, yes—either independent check or validated electronic verification per SOP.

Q: How are partial containers handled?

Print a residual label with a new ID, update quantity and status in WMS, and preserve genealogy; never return unlabelled partials to stock.

Q: How is cross-contamination prevented during weighing?

Use segregated weigh booths, dedicated tools, validated cleaning, controlled airflow, and enforced allergen/hazard segregation with PPE and line clearance logs.

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

Updated October 2025 • Material Identity, Status & Accuracy • Manufacturing, Warehouse, QA

Weighing & Dispensing is the controlled conversion of released inventory into right‑first‑time, traceable components for production. It proves that the right material (identity, lot, status, expiry), the right amount (net weight within tolerance and guardband), and the right unit (UoM, potency/assay adjusted where applicable) were prepared under clean, segregated conditions with calibrated equipment and attributable records. In modern operations this step binds WMS and MES logic via scanners, labels, and scale integrations to deliver a tamper‑evident trail into the eBMR.

“Every good batch starts with a good weigh: right material, right amount, right record—no exceptions, no estimates.”

TL;DR: Scan to prove release status, lot, and expiry (FEFO). Tare the container, weigh to target within SOP tolerance and TNE guardband, apply any UoM conversion/assay correction, and print a verified dispense label. Capture scale ID, calibration check, user, time, and environment into the eBMR. Residuals are relabeled and statused in the WMS; everything is audit‑trailed under Data Integrity and Part 11.

1) What Weighing & Dispensing Covers—and What It Does Not

Covers: identity/status verification, FEFO selection, environmental and segregation controls, scale qualification and checks, tare/net determination, assay or moisture corrections (where defined), labeling and containerization, reconciliation of consumed vs. issued, and real‑time traceability into the batch record. It is the control point that converts warehouse stock into production‑ready components.

Does not cover: supplier testing (CoA confirmation), method validation, or final product release. Those live in QC/QMS frameworks (QC, Component Release, CAPA), while weighing executes the approved recipe step from the MBR/MMR.

2) Legal, System & Data Integrity Anchors

Operate under GMP/GxP with controlled SOPs in Document Control, validated systems (CSV), Part 11/Annex 11 e‑records, named‑user UAM, and immutable audit trails. Scales must be qualified (IQ/OQ/PQ), kept in‑tolerance (calibration status) against NIST traceable weights, and statistically guarded using TNE/MSA.

3) The Evidence Pack for Audit‑Readiness

Maintain the executed MBR step with scans proving item/lot/expiry/status; FEFO pick logic; weigh‑booth line clearance and cleaning logs; environmental conditions (humidity/temperature as applicable); scale ID, daily verification and calibration due‑date; tare method and results; target/actual with tolerance and tare captured; assay/UoM conversions; dispense/return labels; container IDs; user IDs and e‑signatures; reconciliation to inventory; and linked deviations with disposition. Each element should be reconstructable from system records—not spreadsheets.

4) From Goods Receipt to Issue—A Standard Path

1) Verify source. Material arrives via Goods Receipt, undergoes Component Release, and is held under Quarantine/Hold/Release statuses.
2) Pick FEFO. WMS directs the bin pick following FEFO/FIFO and bin location rules.
3) Line clearance & setup. Perform line clearance, stage clean tools, verify scale readiness.
4) Identity & status scan. Scan item/lot to prove identity, release status, and expiry window.
5) Weigh & label. Tare, dispense to target within tolerance/guardband, print verified label, and close the eBMR step.
6) Reconcile & stage. Residuals get new labels/status; kitted components are staged for the job with genealogy preserved.

5) Identity, Status & Expiry Control

Before the first gram is moved, scanners must confirm catalog number, description, lot/serial, release status, and expiry/retest date. FEFO rules protect stability windows and are enforced by WMS, not memory. For regulated allergens or potent/hazard classes, identity drives segregation and PPE requirements, tying to Allergen Control and Cross‑Contamination Control.

6) Scales, Tare & Guardbanding

Use qualified balances sized for the job and verified at the point of use with traceable check weights. Capture tare explicitly; prevent negative or re‑used tares via system controls. Tolerances reflect process risk, scale capability, and TNE guardbanding so “in spec” at the scale remains in spec after error/rounding. Trend checks statistically (SPC control limits) and require re‑verification after moves, shocks, or environment changes.

7) UoM Consistency & Assay/Moisture Corrections

Convert units in governed tables (UoM) and apply assay or moisture content corrections where the MBR requires “as‑is” vs. “active” basis. The calculation must be transparent (inputs, formula, rounding) and captured in the record; unapproved overages are not a substitute for correction factors.

8) Segregation, Weigh Booths & Cleaning

Operate in designated weigh booths with airflow and dust capture appropriate to the risk. Enforce material segregation (e.g., allergens, APIs, sensitizers), dedicated utensils, and validated Cleaning between materials. Link booth status and environmental checks to the eBMR so the record proves conditions were fit‑for‑use.

9) Labeling, Containerization & Kitting

Labels include material name, part number, lot, sub‑lot/dispense ID, net weight & UoM, date/time, operator, expiry/ret test date, and barcodes verified by Barcode Validation. Components are sealed, tamper‑evident where required, and staged to the job via Kitting with genealogy preserved.

10) Exceptions, Rework & Disposition

Over‑ or under‑weighs beyond tolerance trigger system interlocks: scrap and reweigh, or MRB evaluation if the MBR allows blending. Mis‑scans, expired lots, or out‑of‑calibration instruments should block progress, open a Deviation/NC, and route to MRB disposition with labels and inventory corrected automatically.

11) People, PPE & Training

Only trained operators can execute weigh steps; the system should check competency against the Training Matrix and enforce PPE by hazard class. Dual verification or independent checks may be mandated for actives or high‑risk components; log second‑person sign‑off where required.

12) Data Capture & Integration

Capture signals directly from scales (gravimetric integration), block manual entry where interfaces exist, and retain native files where applicable. All transactions should post to inventory in real time, updating bin, status, and quantities with batch‑to‑bin traceability intact.

13) Metrics That Demonstrate Control

Right‑first‑time dispense rate and over/under‑tolerance rate.
Scale verification compliance and calibration on‑time %.
Scan compliance (identity/lot/expiry) and label verification pass‑rate.
Residual reconciliation accuracy and inventory sync latency.
Deviation rate per thousand dispenses and closure cycle time.

These indicators prove the step is accurate, repeatable, and digitally synchronized with inventory and batch records.

14) Common Pitfalls & How to Avoid Them

Rounding into tolerance. Lock rounding rules; never let rounding mask true results.
Shared scale logins. Enforce named users with UAM.
Uncontrolled tare practice. Force tare capture and container ID linkage.
Spreadsheet drift. Replace offline sheets with validated interfaces and audit trails.
Poor segregation. Use dedicated booths/tools and validated cleaning to prevent carryover.
Missing assay corrections. Encode and enforce correction logic in the eBMR.

15) What Belongs in the Weigh/Dispense Record

Material identifier and description; lot and status; expiry/retest date; bin/location; target and tolerance; scale ID and verification; container ID and tare; actual net with UoM; any assay/moisture corrections with formula inputs; operator and (if applicable) verifier; date/time; environmental checks; dispense/return labels; genealogy links to batch/operation; inventory postings; and linked deviations/MRB outcomes. Store under controlled retention with searchable cross‑references.

16) How This Fits with V5 by SG Systems Global

V5 MES + WMS, one flow. The V5 platform unifies MES weigh steps with WMS inventory so FEFO picks, identity scans, and status checks happen before the scale is enabled. The step won’t proceed if the lot is not released, expired, or mis‑picked.

Direct scale integration & guardbands. V5 reads weight from connected balances, enforces TNE guardbands and SOP tolerances, and blocks “keyboard weight.” It logs scale ID, verification checks, and drift monitoring, feeding SPC on check‑weights to catch issues early.

UoM & assay intelligence. Central conversion tables and recipe rules apply UoM and assay/moisture corrections automatically, showing operators the adjusted target and preserving the math in the eBMR for auditability.

Labeling & genealogy by design. V5 prints verified 1D/2D dispense labels, updates residuals with new IDs and statuses, and maintains genealogy from supplier lot to batch operation without manual reconciliation.

Interlocks, exceptions & QA visibility. Mis‑scan, out‑of‑calibration, or out‑of‑tolerance events open controlled exceptions, route to Deviation/MRB, and are visible to QA in real time—no after‑the‑fact cleanup.

Bottom line: V5 makes weighing & dispensing error‑proof and inspection‑ready—scan‑to‑scale‑to‑label with governed math and live inventory control.

17) FAQ

Q1. How tight should weigh tolerances be?
Risk‑based: consider process sensitivity, scale capability (MSA/% readability), and TNE. Tolerance must be achievable and meaningful—not just traditional.

Q2. Can I round weights?
Only per SOP with declared precision. Never round across a tolerance boundary; store the unrounded raw value and the displayed value.

Q3. When do I apply assay or moisture corrections?
When the MBR specifies “as‑is” vs. “active” basis. Pull the assay/moisture from controlled sources, apply governed formulas, and store inputs and results.

Q4. Do I need a second‑person verification?
For high‑risk components (e.g., APIs), yes—either independent check or validated electronic verification per SOP.

Q5. How are partial containers handled?
Print a residual label with new ID, update quantity and status in WMS, and preserve genealogy; never return unlabelled partials to stock.

Q6. What prevents cross‑contamination?
Segregated booths, dedicated tools, validated cleaning, controlled airflow, and enforced allergen/hazard segregation with PPE and line clearance logs.