process for selected packaging materials.

Regulatory Affairs: Ensures that the packaging materials meet all applicable regulatory requirements and standards for the intended market(s).

4. Accountability

The Head of Creams Manufacturing is responsible for overseeing the selection and testing of packaging materials. The QA Manager is accountable for ensuring that all packaging materials comply with quality standards, regulatory requirements, and are suitable for the intended cream formulation.

5. Procedure

5.1 Packaging Material Selection Criteria

1. Packaging materials must be selected based on the following key criteria:
   • Compatibility with the formulation: Ensure that the packaging material does not react with the cream formulation or alter its efficacy, texture, or stability over time.
   • Protection from external factors: Choose materials that protect the cream from light, oxygen, moisture, and contaminants, all of which can degrade the product.
   • Regulatory compliance: Packaging materials must comply with relevant regulatory requirements, including food and drug regulations for the intended market.
   • Functionality: Ensure that the packaging allows for easy dispensing, proper storage, and does not cause product wastage.
   • Aesthetics and branding: The packaging should align with the brand’s identity and appeal to the target consumer.
2. Consider the cost-effectiveness of the packaging materials, ensuring that they are within the budget without compromising quality or functionality.

5.2 Selection of Primary Packaging Materials

1. Primary packaging materials directly come into contact with the cream product, such as tubes, jars, or pumps. Select materials that provide an adequate barrier to preserve the quality of the cream formulation. Options may include:
   • Plastic containers (e.g., HDPE, PET)
   • Glass containers
   • Aluminum tubes
   • Airless pumps or squeeze tubes for creams sensitive to contamination
2. Ensure that the selected primary packaging is compatible with the cream’s formulation, and that it preserves the product’s integrity throughout its shelf life.
3. Test packaging materials for:
   • Chemical compatibility
   • Moisture permeability
   • Light resistance
   • Physical integrity (e.g., breakage or leakage during handling)

5.3 Selection of Secondary Packaging Materials

1. Secondary packaging materials protect the primary packaging and provide additional branding and product information. Options may include:
   • Cardboard cartons
   • Blister packs
   • Shrink wraps or labels
   • Display packaging for retail
2. Ensure that secondary packaging protects the product during transit, storage, and handling, and that it provides clear and accurate labeling for the consumer.
3. Test the secondary packaging for:
   • Structural integrity (ability to protect the primary packaging)
   • Print quality (legibility of labels and instructions)
   • Compliance with regulatory labeling requirements (e.g., ingredient list, batch number, expiry date)

5.4 Packaging Material Testing

1. All selected packaging materials must undergo testing to ensure that they do not negatively impact the cream formulation. This testing includes:
   • Compatibility testing: Evaluate whether the packaging material interacts with the cream, such as leaching of chemicals into the product.
   • Stability testing: Ensure that the packaging maintains the product’s quality over time under various storage conditions (e.g., temperature, humidity, light exposure).
   • Migration testing: Test for any migration of substances from the packaging material into the cream.
2. Conduct testing on both primary and secondary packaging materials, and document the results in the Packaging Testing Report (Annexure-1).

5.5 Regulatory Compliance

1. Ensure that all packaging materials selected for use in cream formulations comply with local and international regulatory standards, such as:
   • Food and Drug Administration (FDA) regulations
   • European Medicines Agency (EMA) guidelines
   • ISO standards for packaging materials
2. Review packaging material specifications and documentation for any regulatory certifications required for the intended market.
3. Submit packaging material specifications to regulatory authorities, if necessary, for approval before commercialization.

5.6 Packaging Material Approval

1. Upon successful testing and regulatory review, prepare a Packaging Material Approval Report (Annexure-2) for the selected primary and secondary packaging materials.
2. Submit the report to the QA team for final review and approval. Once approved, the materials can be procured for commercial production.
3. Keep a record of all approved packaging materials for future reference and regulatory audits.

5.7 Packaging Material Procurement and Usage

1. After approval, initiate procurement of the selected packaging materials through the procurement department.
2. Ensure that the materials are stored properly in a clean, dry environment to avoid contamination or degradation before use in production.
3. Regularly monitor packaging material inventory to ensure availability and prevent stockouts that could delay production.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practices
• FDA: Food and Drug Administration
• EMA: European Medicines Agency

7. Documents

1. Packaging Testing Report (Annexure-1)
2. Packaging Material Approval Report (Annexure-2)
3. Packaging Material Specifications (Annexure-3)

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• FDA Regulations on Packaging Materials for Pharmaceutical Products
• ISO 9001:2015 – Quality Management Systems

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 Testing Report

Test Type	Test Result	Test Date	Approval Status
Compatibility Test	Pass	12/07/2025	Approved

Annexure-2: Packaging Material Approval Report

Packaging Material	Approval Status	Approval Date	Comments
Plastic Tubes (HDPE)	Approved	15/07/2025	No issues, meets specifications
Aluminum Jars	Approved	15/07/2025	Meets regulatory standards, no migration

Annexure-3: Packaging Material Specifications

Material Type	Specifications	Supplier	Batch No.	Compliance
HDPE Tube	Light-resistant, 50g capacity	ABC Packaging	Tube-101	Compliant with FDA regulations
Aluminum Jar	Leak-proof, 100g capacity	XYZ Packaging	Jar-202	Compliant with European Medicines Agency (EMA) guidelines

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head