Packaging Environmental Control Specification
This specification defines the Quality Unit–approved environmental acceptance criteria and decision requirements for GMP-designated packaging areas.
Authoritative Quality Control specification defining environmental acceptance criteria and decision logic. This document does not define execution steps, monitoring methods, or procedural instructions.
1. Purpose
To establish Quality Unit–approved temperature and relative humidity acceptance criteria for packaging operations, ensuring that environmental conditions do not adversely impact product quality, packaging integrity, or labeling throughout GMP packaging activities.
2. Scope
This specification applies to all GMP-designated packaging areas where finished products, components, labels, or packaging materials are exposed during packaging, labeling, or related handling activities.
Applicable Business Domains include:
- Packaging Operations (PKG)
- Quality Assurance (QA)
- Quality Control (QC)
- Production (PROD), when packaging activities occur within controlled areas
3. Ownership & Governance
- Owner: Quality Control (Quality Unit)
- Approver: Quality Control Operations (QCO)
- Change Control: Quality Management System (QMS)
- Requirement Authority: QC-REQ-IDX
- QC-REQ-IDX Reference: QC-ENV-003
Environmental acceptance criteria and decision thresholds defined in this specification shall not be modified outside approved QMS change control.
4. Environmental Acceptance Criteria
| Parameter | Acceptance Criteria | Applicability |
|---|---|---|
| Temperature | 15°C – 25°C | All GMP-designated packaging areas |
| Relative Humidity | ≤ 60% RH | All GMP-designated packaging areas unless otherwise specified by product- or material-specific requirements |
5. Decision Logic
- Environmental conditions maintained within acceptance criteria are considered conforming.
- Single, brief excursions outside acceptance criteria require documented review by Quality Assurance.
- Repeated, extended, or trending excursions — or excursions occurring during active packaging operations — require escalation to Quality Control.
- Final product disposition decisions are made by the Quality Unit based on documented review, risk assessment, and material impact evaluation.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following conditions are met:
- Environmental parameters exceed acceptance criteria beyond defined tolerances
- Recurring or adverse environmental trends are identified
- Excursions occur during active packaging or labeling operations
- Environmental conditions may impact product quality, labeling, or packaging integrity
- Monitoring reliability or data integrity concerns are identified
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Environmental monitoring data for packaging areas
- Deviation or excursion reviews and investigations
- Quality Assurance assessments and escalation records
- Quality Unit disposition decisions and supporting rationale