quality standards.

Quality Assurance (QA): Ensures that the antioxidant addition process is compliant with this SOP and that all documentation related to antioxidant use is complete and accurate.

R&D/Technical Team: Provides guidance on the appropriate type and concentration of antioxidants for specific cream formulations and assists in troubleshooting any formulation issues related to antioxidants.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that antioxidants are used correctly according to this SOP. The QA Manager is accountable for ensuring compliance and verifying that antioxidants are correctly documented and that final products meet the required specifications.

5. Procedure

5.1 Selection of Antioxidants

1. Select antioxidants based on the requirements of the cream formulation, considering factors such as the expected shelf life of the product, the type of active ingredients, and the sensitivity to oxidation.
2. Common antioxidants used in creams include Vitamin E, butylated hydroxyToluene (BHT), ascorbic acid, and rosemary extract. The choice of antioxidant should be based on the formulation’s specific needs.
3. Ensure that the selected antioxidant is approved for use in cosmetics or pharmaceutical products and complies with relevant regulatory standards (e.g., FDA, EU).
4. The R&D or Technical Team should provide guidelines on the appropriate concentration of antioxidants to be used in the formulation, as excessive concentrations may affect product texture or stability.

5.2 Preparation for Adding Antioxidants

1. Before adding antioxidants, ensure that the cream formulation is in the correct phase (usually after emulsification and before the cooling stage) and that the temperature is below the threshold that could degrade the antioxidant (typically less than 40°C).
2. Measure the required amount of antioxidant accurately, using calibrated weighing equipment to ensure proper dosage.
3. If the antioxidant is in a solid form, ensure it is fully dissolved or dispersed in a suitable solvent or base before addition. For liquid antioxidants, ensure that they are homogeneously mixed into the cream.

5.3 Addition of Antioxidants

1. Add the antioxidant to the cream formulation slowly and gently to avoid air entrainment or over-shear mixing, which may degrade the antioxidant.
2. Ensure that the antioxidant is thoroughly mixed into the cream without causing phase separation or affecting the texture of the formulation.
3. Use low shear mixing equipment to incorporate the antioxidant to prevent any damage or degradation of the active ingredient.
4. Monitor the temperature of the mixture during the addition to ensure it remains within the specified range for antioxidant stability.

5.4 Monitoring and Testing

1. After the addition of antioxidants, conduct initial testing to verify that the cream remains stable and does not exhibit any signs of instability, such as separation or discoloration.
2. Perform routine quality control tests such as pH measurement, viscosity testing, and appearance checks to ensure that the addition of the antioxidant has not altered the formulation in an undesirable way.
3. The QC team should test for oxidative stability periodically during the cream’s shelf life, as part of the stability testing, to ensure that the antioxidant is effectively preventing oxidation.

5.5 Documentation

1. Document the entire process of adding antioxidants in the batch record, including the type and amount of antioxidant used, the batch number, the temperature at the time of addition, and any observations during the process.
2. Include any QC testing results related to antioxidant efficacy, such as stability testing or visual inspections, in the batch record.
3. Ensure that the batch record is reviewed and signed off by the QA team before the cream moves to the next stage of production or packaging.

5.6 Final Approval and Use of the Cream

1. Once the antioxidant is incorporated and the cream passes all required tests, the formulation is ready for the next stage of production or packaging.
2. Ensure that all batch documentation is complete and that the cream is labeled with the appropriate batch number and antioxidant information for traceability purposes.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practices
• API: Active Pharmaceutical Ingredient
• MFR: Master Formula Record

7. Documents

1. Batch Record (Annexure-1)
2. Viscosity Test Report (Annexure-2)
3. pH Test Report (Annexure-3)
4. Antioxidant Efficacy Test Report (Annexure-4)

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidelines for Cosmetics Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number	Ingredient	Quantity Used	Time of Addition	Operator
12345	Vitamin E	1.0 g	10:00 AM	John Doe

Annexure-2: Viscosity Test Report

Batch Number	Viscosity	Specification	Remarks
12345	1500 cP	1000 – 2000 cP	Pass

Annexure-3: pH Test Report

Batch Number	pH	Specification	Remarks
12345	5.2	4.5 – 6.5	Pass

Annexure-4: Antioxidant Efficacy Test Report

Batch Number	Antioxidant	Efficacy Test Result	Specification	Remarks
12345	Vitamin E	Pass	≥ 95% effectiveness	Effective in preventing oxidation

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