Standard Operating Procedure for Packaging Material Selection for Granules

1) Purpose

The purpose of this SOP is to outline the procedure for selecting appropriate packaging materials for granules in the pharmaceutical industry to ensure compatibility, stability, and integrity of the packaged product.

2) Scope

This SOP applies to all personnel involved in the selection of packaging materials for granules within the pharmaceutical manufacturing department.

3) Responsibilities

Quality Assurance (QA) Specialist: Responsible for approving packaging material specifications.
Production Manager: Responsible for ensuring that selected packaging materials meet regulatory and quality standards.

4) Procedure

1. Review Requirements:
   1. Review the formulation and physical properties of the granules.
   2. Identify specific requirements such as moisture barrier, light protection, and chemical resistance.
2. Evaluate Material Options:
   1. Identify potential packaging materials based on the requirements.
   2. Evaluate materials for compatibility with the granules, considering interactions that may affect stability.
3. Perform Compatibility Testing:
   1. Conduct compatibility studies between selected packaging materials and granules.
   2. Assess physical and chemical stability of the granules over time in the selected packaging.
4. Assess Regulatory Compliance:
   1. Verify compliance of selected packaging materials with relevant regulatory standards (e.g., FDA, EMA).
   2. Ensure materials meet requirements for safety, labeling, and environmental impact.
5. Documentation:
   1. Document the selection process, including rationale for material choices and results of compatibility testing.
   2. Maintain records of packaging material specifications and approvals.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
FDA: Food and Drug Administration
EMA: European Medicines Agency

6) Documents, if any

Packaging Material Specifications, Compatibility Testing Reports, Regulatory Compliance Certificates

7) Reference, if any

Pharmacopeial guidelines and regulatory requirements for pharmaceutical packaging materials.

8) SOP Version

Version 1.0