Production Environmental Control Specification

Specification ID: QC-ENV-002
Version: 1.0
Status: Approved
Effective Date: 2026-02-01
Owner: Quality Control (Quality Unit)
Approved By: Quality Control Operations (QCO)
Change Control: CC-2026-005

1. Purpose

This specification defines Quality Unit–approved environmental acceptance criteria for GMP-designated production areas to ensure controlled manufacturing conditions that protect product identity, purity, strength, composition, and safety.

2. Scope

This specification applies to all GMP-classified production areas where manufacturing, blending, encapsulation, tableting, or in-process handling of materials or product occurs.

3. Environmental Acceptance Criteria

The environmental acceptance criteria defined below represent Quality Unit–approved requirements governing production area conditions. These criteria establish the allowable operating limits used to support consistent process performance and product quality.

These values are authoritative and shall not be modified, reinterpreted, or duplicated in procedures, work instructions, or records outside this specification.

Controlled Parameter Approved Acceptance Criteria Decision Authority
Production Area Ambient Temperature 68°F to 77°F Quality Unit (QCO)
Production Area Relative Humidity ≤ 50% RH Quality Unit (QCO)
Approved Decision Scope and Enforcement:
The acceptance criteria listed above constitute the Quality Unit–approved environmental limits for GMP-designated production areas.

Environmental conditions outside these limits require documented evaluation in accordance with approved Quality Assurance procedures and may require escalation to the Quality Unit for assessment, disposition, or corrective action.

Any change to these acceptance criteria requires formal change control and approval by Quality Control Operations (QCO).

4. Execution & Evidence

Execution of environmental monitoring, alarm response, and documentation is performed by Quality Assurance and applicable Business Domains in accordance with approved procedures.

Records generated through monitoring systems and logs constitute objective evidence of compliance with this specification.

5. References