primary and secondary packaging materials being introduced for use in the packaging of injectable products manufactured at the facility, including but not limited to vials, ampoules, stoppers, flip-off seals, syringes, cartons, and labels.

3. Responsibilities

• Procurement Team: Initiates the request for evaluation of new packaging materials.
• QA Officer: Coordinates document collection and organizes sample review and testing.
• QC Department: Conducts analytical testing and compatibility studies.
• Packaging Development: Reviews material specifications and suitability for production equipment.
• Head QA: Final approval of the new packaging material based on evaluation outcomes.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that no new packaging material is used unless it has undergone complete evaluation and approval as per this SOP.

5. Procedure

5.1 Initiation

1. Procurement or R&D raises a Packaging Material Evaluation Request (PMER) form (Annexure-1).
2. QA assigns a unique Evaluation Reference Number (ERN) to the request.

5.2 Document Collection and Preliminary Evaluation

1. QA requests the following documents from the vendor:
   • Certificate of Analysis (CoA)
   • Material Safety Data Sheet (MSDS)
   • USP/EP compliance certification
   • DMF (if applicable)
   • Technical data sheet
2. Verify documents for completeness and authenticity.

5.3 Physical and Analytical Evaluation

1. QC performs:
   • Dimensional testing (as per specification)
   • Appearance and visual inspection
   • Extractables and leachables (if applicable)
   • Label adhesion, print clarity, and color fastness for printed materials
2. Results are documented in the Packaging Material Evaluation Report (Annexure-2).

5.4 Compatibility and Line Trial

1. Packaging Development conducts line trials using the new material under controlled batch or trial conditions.
2. Evaluate:
   • Machine compatibility
   • Filling and sealing performance
   • Any abnormal rejection or stoppages
3. Trial outcome is documented in the Line Trial Report (Annexure-3).

5.5 Final Approval

1. QA consolidates all findings and prepares the Packaging Material Approval Summary (Annexure-4).
2. Head QA reviews and approves the material for routine use.
3. Approved packaging materials are added to the Approved Vendor List and Packaging BOMs.

5.6 Re-evaluation and Rejection

1. Materials failing compatibility or specification criteria are rejected.
2. QA issues a Packaging Material Rejection Memo and communicates the decision to Procurement.
3. All materials shall be re-evaluated every 3 years or if a major change in formulation or specification occurs.

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• PMER: Packaging Material Evaluation Request
• MSDS: Material Safety Data Sheet
• DMF: Drug Master File
• USP/EP: United States Pharmacopeia/European Pharmacopoeia

7. Documents

1. Packaging Material Evaluation Request – Annexure-1
2. Packaging Material Evaluation Report – Annexure-2
3. Line Trial Report – Annexure-3
4. Packaging Material Approval Summary – Annexure-4

8. References

• ICH Q10: Pharmaceutical Quality System
• 21 CFR Part 211 – Subpart G: Packaging and Labeling Control
• 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	QA Executive	QA Manager	Head QA
Department	Quality Assurance	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Packaging Material Evaluation Request

Request ID	PMER-0625-01
Date	20/06/2025
Material	Glass Vial 10 mL Type I
Requested By	Sunita Reddy
Department	Procurement

Annexure-2: Packaging Material Evaluation Report

Test	Specification	Result	Remark
Height	45 mm ± 1 mm	45.2 mm	Pass
Visual Clarity	No defects	Clear	Pass

Annexure-3: Line Trial Report

Date	Machine	Batch	Observation	Status
21/06/2025	Vial Filler-01	Trial-GLV-01	No blockage or misalignment	Accepted

Annexure-4: Packaging Material Approval Summary

Material	Glass Vial 10 mL Type I
Supplier	Borosil Ltd.
Trial Outcome	Accepted
QC Result	Compliant
QA Approval	Approved on 23/06/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/04/2022	1.0	Initial version released	New SOP	Head QA
24/06/2025	2.0	Line trial section added	Annual review	Head QA