Hold Time Studies

This topic is part of the SG Systems Global Guides library for regulated manufacturing teams evaluating eBMR, MES, and QMS controls.

Updated December 2025 • hold time studies, WIP holds, intermediate stability, time limits, humidity/temperature controls, sampling plans, release gating, audit trails • Dietary Supplements (USA)

Hold time studies establish how long an in-process material, bulk intermediate, or finished product can be held between steps without compromising quality. In dietary supplements, hold times are not academic. They are one of the most common “quiet drift” failure modes in real plants: a blend sits too long, a granulation step pauses overnight, bulk capsules wait in totes for days, or packaged goods sit in staging under uncontrolled conditions. Nothing looks wrong until uniformity, potency, moisture, or microbial risk drifts—then QA has to explain why the timeline was acceptable.

Buyers searching for hold time studies are usually trying to reduce two costs at once: (1) operational delays caused by conservative “we always scrap after X hours” rules, and (2) investigation delays caused by weak evidence about what was held, where it was held, and under what conditions. A mature approach treats hold time as a controlled parameter—like a critical process parameter (CPP)—with defined limits, documented conditions, and system-enforced gates.

“If you can’t prove how long it sat and under what conditions, you can’t prove the hold was acceptable.”

1) What buyers mean by hold time studies

Operational buyers mean: “How long can we stop without creating risk?” QA buyers mean: “How do we prove it was safe when we stopped?” Hold time studies bridge those realities. They define time limits between steps and the conditions required for the material to remain conforming. They are often the missing link between process validation thinking and real-world production scheduling.

Hold time studies also enable faster decisions under pressure. When a line stops, the team shouldn’t debate whether a blend is “still good.” The system should know the limit, record the conditions, and show whether the hold is within bounds. That reduces the number of discretionary decisions that later become deviations.

2) Why hold time failures happen (and why they’re hard to see)

Hold time failures happen because time is invisible in paper records and informal workflows. A tote sits in staging and nobody records when it was filled. A blender finishes at 2:00 AM and the next step starts “sometime tomorrow.” A WIP lot is split and some of it continues while the rest pauses. The record still looks complete, but the evidence is weak.

They’re hard to see because the drift is subtle. Potency may remain within spec but trend toward the edge. Moisture pickup may not show until compression issues appear. Micro risk may increase under poor humidity control but not trigger until later. Without time-and-condition evidence, you can’t do meaningful root cause analysis (RCA) and you can’t defend release decisions.

3) Scope: what requires hold times in supplement manufacturing

Hold times should be defined anywhere a material state can sit between controlled steps. Typical supplement examples:

• Weighed/dispensed ingredients staged before blending (staging/kitting)
• Blends held before encapsulation/tableting
• Granulation/wet mass held before drying or milling
• Bulk capsules/tablets held before packaging
• Packaged finished goods held before QA release (release status)
• Sampling holds while waiting for lab results (LIMS integration environments)

The scope should be risk-based; you don’t need a complex study for every minor pause. But you do need defined limits for intermediates that are sensitive to moisture, segregation, microbial growth, oxidation, or potency drift.

4) Risk model: which intermediates are most sensitive

Hold time risk is driven by material properties and environment. A practical risk model considers:

This risk model informs how conservative your time limits must be and what conditions you must enforce (sealed containers, nitrogen purge, temperature/humidity ranges, etc.).

5) Study design: conditions, sampling, and acceptance criteria

A hold time study should be designed to answer one question: “Does the intermediate remain within acceptable limits under defined conditions for the proposed time?” That requires three elements:

• Defined conditions (container type, closure, temperature/humidity, light exposure).
• Sampling plan that makes sense for risk and variability (sampling plans).
• Acceptance criteria tied to real specifications, not preferences (QC release evidence).

For blends, this might include assay and uniformity proxies; for moisture-sensitive intermediates, it might focus on moisture content and flow behavior; for micro-sensitive materials, it may include microbial indicators. The output should be a clear, enforceable rule: “Hold time limit is X hours/days under Y conditions.”

6) Storage conditions: temperature, humidity, light, and container effects

Many plants do hold time studies but fail because they don’t control conditions. “Held in the warehouse” is not a condition. A good program defines storage requirements as part of the hold rule—often tied to temperature mapping and environmental monitoring expectations.

Container and closure matter. A sealed drum with a liner behaves differently than an open tote. A nitrogen-flushed container behaves differently than a vented bin. Your hold rules should specify the allowed container types and sealing requirements. Otherwise, operators will choose whatever is available, and the study won’t match reality.

7) Data integrity: proving time, location, and condition

Hold time compliance depends on reliable timestamps and traceable movements. If time is entered manually, it will be wrong under pressure. A defensible approach:

• Auto-stamp hold start/stop events with user and time (attributable, contemporaneous).
• Link holds to lot/container identity (chain of custody).
• Capture location history (where it was held, not where it “should have been”).
• Preserve audit trails for any changes with reason-for-change.

This is where eBMR/MES/WMS integration pays off. If your WIP movements are scan-verified (bin/location management) and holds are tracked as status events, QA can prove compliance quickly without reconstructing timelines.

8) Enforcement: system gates, holds, and disposition when limits are exceeded

The point of a hold time study is not to create a binder. It’s to create an enforceable limit. When a hold exceeds the limit, the system should automatically:

• Place the lot on hold/quarantine
• Block consumption or progression via hard gating
• Route the event into deviation management and require a documented disposition (QA disposition)
• Trigger additional testing or review based on the defined escalation model

9) WIP holds, split/merge events, and lot genealogy impacts

Hold time becomes more complex when WIP is split or merged. A blend lot may be split across two packaging runs, with one half held longer. If your genealogy doesn’t track those splits, you can’t prove which finished lots were exposed to extended holds. This is why hold time rules should be attached to the lot/container level, not only to the “batch” concept.

Link hold events to end-to-end lot genealogy so impact assessments are fast. This is the difference between “we think it was fine” and “we can prove which units were impacted.”

10) Change control: when hold time limits must be revisited

Hold time limits are not permanent. They should be revisited when:

• Supplier changes affect material properties (Supplier Change Notifications)
• Process parameters or equipment change (change control)
• Packaging/container types change
• Environmental controls change (warehouse HVAC, humidity control)
• Trending shows drift toward spec edges (OOT)

When these triggers occur, the hold time rule becomes a controlled document revision with effective dating. This protects you from using old hold time assumptions after the system has changed.

11) KPIs that show payback

The business payoff is that validated hold limits reduce unnecessary scrap while system enforcement reduces hidden drift. Both improve release confidence and shorten QA review time.

12) Copy/paste demo script and selection scorecard

Use this demo script to evaluate whether a system can enforce hold times without manual policing.

13) Selection pitfalls (how “studies” become opinions)

• Manual timestamps. If holds rely on handwritten times, your evidence will degrade under pressure.
• No location history. If you can’t show where it was held, you can’t defend condition assumptions.
• Warning-only limits. If the system doesn’t block use when limits are exceeded, limits aren’t real.
• Rules not tied to identity. If the hold rule applies to “the batch” but not containers, split lots create ambiguity.
• No change control triggers. Hold time limits stay static while materials/process change.
• No trending. Repeated holds become normal because nobody sees the pattern early.
• Study doesn’t match operations. Conditions tested (container, humidity) don’t match what the plant actually does.

14) How this maps to V5 by SG Systems Global

V5 supports hold time studies by connecting lot identity, WIP movement, and quality governance—so holds are time-stamped, enforceable, and traceable to release decisions.

• Execution: V5 MES supports step-level execution and gates that can enforce hold limits before work continues.
• Quality governance: V5 QMS supports deviations, dispositions, approvals, and audit-ready records tied to hold events.
• Inventory enforcement: V5 WMS supports scan-verified movements, location history, and hold/quarantine enforcement.
• Integration: V5 Connect API supports connectivity to lab systems and environmental data where required.
• Industry fit: Dietary Supplements Manufacturing shows how these controls map to supplement operations.
• Platform view: V5 solution overview.

15) Extended FAQ

Q1. What is a hold time study?
It’s evidence that an intermediate or product remains within acceptable limits for a defined time under defined storage conditions between steps.

Q2. What should we test in a hold time study?
Test what is most likely to drift for that intermediate: potency/uniformity proxies, moisture, micro indicators, physical properties, or known risk attributes.

Q3. Do hold times apply to finished goods too?
Yes—especially when finished goods are staged before release or shipped under condition-sensitive requirements. Time and condition still matter.

Q4. What happens if a hold time limit is exceeded?
The lot should be held/quarantined, blocked from use, and routed into deviation/disposition with defined escalation testing or review as required.

Q5. What’s the fastest way to improve hold time compliance?
Remove manual timestamps, enforce scan-verified holds, hard-gate exceedances, and trend where scheduling/environment creates repeat holds.

Related Reading
• Supplements Industry: Dietary Supplements Manufacturing
• Core Guides: eBMR for Supplements | Batch Release Software | Deviation Management | CAPA for Dietary Supplements
• Adjacent Guides: Inventory Quarantine System | Raw Material Traceability | Review by Exception
• Glossary: Process Validation | Quarantine / Hold Status | Lot Genealogy | Out of Trend (OOT)
• V5 Products: V5 Solution Overview | V5 MES | V5 QMS | V5 WMS | V5 Connect API