Material Storage & Handling Acceptance Specification

This specification defines the Quality Unit–approved acceptance criteria and decision requirements governing the storage and handling condition of materials used in GMP operations.

Specification Type:
Authoritative Quality Control specification defining material storage and handling acceptance criteria and decision authority. This document does not define warehouse procedures, handling methods, or operational workflows.

1. Purpose

To establish Quality Unit–approved requirements for evaluating the condition of materials during storage and handling, ensuring that materials remain suitable for their intended GMP use and are protected from damage, contamination, or compromise.

2. Scope

This specification applies to all components, raw materials, in-process materials, and packaging components stored or handled within GMP-designated areas prior to use.

Applicable Business Domains include:

Warehouse Operations (WH)
Quality Assurance (QA)
Quality Control (QC)
Production (PROD)
Packaging (PKG)

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-MAT-004

Material storage and handling acceptance criteria defined in this specification shall not be modified outside approved QMS change control.

4. Storage & Handling Acceptance Criteria

Attribute	Acceptance Criteria	Applicability
Container Integrity	Containers shall be intact, sealed as appropriate, and free from damage, leakage, or evidence of tampering.	All stored and handled materials
Material Identification	Materials shall be clearly and correctly labeled to ensure traceability and prevent mix-ups.	All materials during storage and handling
Protection from Contamination	Materials shall be protected from environmental exposure, cross- contamination, and foreign matter during storage and handling.	All GMP-relevant materials
Segregation Status	Materials shall be appropriately segregated by status (e.g., quarantined, released, rejected) to prevent unintended use.	All materials subject to quality status control
Damage or Compromise	Materials exhibiting evidence of damage, deterioration, or compromise shall not be used unless evaluated and approved by the Quality Unit.	All materials

Acceptance of material storage and handling condition is based on documented assessment and, where applicable, inspection records. Absence of visible compromise is the minimum acceptance expectation.

5. Decision Logic

Materials meeting storage and handling acceptance criteria are considered conforming for condition.
Materials exhibiting minor or isolated deficiencies require Quality Assurance review prior to use.
Materials exhibiting significant damage, loss of integrity, or evidence of contamination shall not be used without Quality Unit approval.
Final determinations regarding material condition acceptance reside with the Quality Unit.

6. Escalation Requirements

Quality Assurance must escalate to Quality Control or QCO when any of the following occur:

Evidence of material damage, compromise, or contamination
Loss of container integrity or labeling discrepancies
Improper segregation or status control issues
Recurring storage or handling deficiencies

7. Records & Evidence

Records supporting compliance with this specification include, but are not limited to:

Material inspection and condition assessment records
Deviation and investigation documentation related to material condition
Quality Assurance reviews and escalation records
Quality Unit decisions regarding material usability

This specification defines material storage and handling acceptance criteria and decision authority only. Warehouse procedures, handling techniques, and operational controls are defined in separate controlled documents and shall not redefine the requirements herein.