Standard Operating Procedure for Approval of Packaging Material Specifications
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/213/2025 |
| Supersedes | SOP/TAB/213/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
This SOP outlines the procedure for the approval of packaging material specifications used in tablet production. The purpose is to ensure that all packaging materials meet regulatory requirements, product quality standards, and are suitable for their intended use.
2. Scope
This SOP applies to the approval of all packaging materials used in the tablet manufacturing process, including primary and secondary packaging materials such as bottles, blister packs, labels, and carton boxes.
3. Responsibilities
- Quality Assurance (QA) Manager: Responsible for overseeing the approval process for packaging material specifications and ensuring that materials comply with quality standards and regulatory requirements.
- Packaging Development Team: Responsible for preparing packaging material specifications and coordinating with suppliers to ensure compliance with required standards.
- Regulatory Affairs Team: Ensures that packaging materials comply with FDA, GMP, and other relevant regulations.
- Procurement Team: Responsible for sourcing approved packaging materials from authorized suppliers and ensuring timely delivery.
4. Accountability
The QA Manager is accountable for ensuring that packaging materials meet regulatory and quality standards and for approving packaging material specifications. The Packaging Development and Procurement Teams are responsible for preparing and sourcing packaging materials.
5. Procedure
5.1 Submission of Packaging Material Specifications
- The Packaging Development Team submits the proposed packaging material specifications to the QA Manager for approval.
- Specifications should include:
- Material type and grade (e.g., plastic, glass, paperboard)
- Dimensions, weight, and tolerances
- Compatibility with tablet formulation (e.g., moisture protection, oxygen permeability)
- Printing and labeling requirements
- Ensure that packaging materials meet product requirements, including stability, safety, and regulatory compliance (Annexure-1).
5.2 Review of Packaging Material Specifications
- The QA Manager reviews the submitted packaging material specifications to ensure they comply with FDA guidelines, GMP, and company standards.
- The following factors should be reviewed:
- Material safety and suitability for contact with the tablet product
- Compliance with regulatory labeling and printing requirements
- Stability and protective properties of the packaging material
- Consult with Regulatory Affairs to ensure packaging material compliance with all applicable regulations (e.g., FDA, EU, etc.).
5.3 Approval or Rejection of Packaging Material Specifications
- If the packaging material specifications meet all requirements, the QA Manager approves the specifications for use in tablet production (Annexure-2).
- If the specifications do not meet requirements, the Packaging Development Team is required to modify the specifications and resubmit for review.
- Record the approval or rejection of specifications in the Packaging Material Approval Log (Annexure-3).
5.4 Supplier Qualification
- Once packaging material specifications are approved, the Procurement Team will engage with approved suppliers to source the material.
- Verify that suppliers meet all quality and regulatory requirements for the packaging materials (Annexure-4).
- Conduct supplier audits and review performance to ensure ongoing compliance with specifications.
5.5 Documentation and Record Keeping
- Maintain records of all approved packaging material specifications, including technical data sheets, compliance documentation, and approval signatures (Annexure-5).
- Ensure that records are accessible for future audits and inspections and kept for a minimum of 5 years or as required by regulatory authorities.
5.6 Periodic Review of Packaging Material Specifications
- Review packaging material specifications periodically to ensure they remain in compliance with evolving regulatory requirements and product needs.
- Update specifications as necessary and re-submit for approval if changes are made (Annexure-6).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- FDA: Food and Drug Administration
- Packaging Development: Team responsible for packaging material specifications
- CAPA: Corrective and Preventive Action
7. Documents
- Packaging Material Specifications (Annexure-1)
- Packaging Material Approval Log (Annexure-2)
- Supplier Qualification Records (Annexure-3)
- Packaging Material Compliance Documentation (Annexure-4)
- Packaging Material Approval Records (Annexure-5)
- Updated Packaging Material Specifications (Annexure-6)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- USP <661> – Plastic Materials of Construction
- ISO 15378 – Primary Packaging Materials for Medicinal Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Packaging Material Specifications
| Material Type | Specifications | Compliance Status |
|---|---|---|
| Plastic Bottles | High-density polyethylene (HDPE), 50 ml | Compliant |
Annexure-2: Packaging Material Approval Log
| Material Type | Approval Status | Approval Date |
|---|---|---|
| Plastic Bottles | Approved | 01/03/2026 |
Annexure-3: Supplier Qualification Records
| Supplier Name | Material Supplied | Qualification Date | Audit Result |
|---|---|---|---|
| ABC Packaging | Plastic Bottles | 01/02/2026 | Pass |
Annexure-4: Packaging Material Compliance Documentation
| Material Type | Compliance Document | Expiration Date |
|---|---|---|
| Plastic Bottles | Certificate of Compliance | 01/03/2027 |
Annexure-5: Packaging Material Approval Records
| Approval Date | Material Type | Approval Status |
|---|---|---|
| 01/03/2026 | Plastic Bottles | Approved |
Annexure-6: Updated Packaging Material Specifications
| Material Type | Updated Specifications | Approval Date |
|---|---|---|
| Plastic Bottles | HDPE, 100 ml, Food-grade | 02/03/2026 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated approval process | Clarified responsibilities | QA Head |