GMP vs. Non-GMP Setting in Materials & Equipment

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  • 更新日 Mar 12, 2026
  • 公開日 Mar 12, 2026
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GMP vs. Non-GMP Setting in Materials & Equipment

Overview

In Tempo, both Materials and Equipment can be designated as GMP or Non-GMP.

Although the setting appears similar in the configuration screen, the system behavior differs significantly between Materials and Equipment.

This article explains what the GMP designation does — and does not do — in each case.

Equipment: GMP Setting

When an Equipment instance is marked as GMP:

  • The setting functions as an identifier only

  • It does not trigger additional workflows

  • It does not require additional signatures

  • It does not enforce compliance controls in the background

Important

Selecting GMP for Equipment does not change system behavior.
It is informational and can be used for classification or reporting purposes only.

Materials: GMP Setting

When a Material is marked as GMP, the setting actively impacts execution behavior.

What Changes When a Material is GMP?

1. Dual Signature Enforcement

GMP materials require a second signature when performing material-related actions.

This includes:

  • Dispensing material

  • Consuming material

  • Creating output lots

2. Output Lot Creation

When creating output lots from a GMP material, a second signature is mandatory before completion.

Side-by-Side Comparison

Setting Applied To

System Enforcement

Signature Impact

Equipment

Identifier only

No additional signatures

Material

Compliance enforced

Requires second signature

Key Takeaway

  • Equipment GMP = Informational flag

  • Material GMP = Compliance control (dual signature required)

If your goal is to enforce GMP-compliant execution workflows, ensure the GMP designation is applied at the Material level.