Creams: SOP for Adding Active Ingredients in Cream Manufacturing – V 2.0

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Creams: SOP for Adding Active Ingredients in Cream Manufacturing – V 2.0

Standard Operating Procedure for Adding Active Ingredients in Cream Manufacturing

Department Creams
SOP No. SOP/CRM/043/2025
Supersedes SOP/CRM/043/2022
Page No. Page 1 of 6
Issue Date 28/09/2025
Effective Date 03/10/2025
Review Date 28/09/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for adding active ingredients into cream formulations during the manufacturing process. This procedure ensures that active ingredients are incorporated in the correct sequence, concentration, and under appropriate conditions to preserve their efficacy and stability in the final product.

2. Scope

This SOP applies to all cream formulations in the Creams Department where active ingredients are added to the emulsion base or final cream. It covers the procedure from the moment the cream base is prepared until the active ingredients are thoroughly mixed into the formulation.

3. Responsibilities

  • Formulation Development Team: Responsible for selecting appropriate active ingredients for each cream formulation and defining the correct concentrations and timing for their addition.
  • Quality Control (QC): Responsible for verifying the quality and concentration of the active ingredients and ensuring that they are within specification before addition to the formulation.
  • Quality Assurance (QA): Ensures that the process for adding active ingredients is followed as per this SOP and that the final product meets regulatory and quality standards.
  • Production Team: Responsible for carrying out the addition of active ingredients, ensuring that they are added at the correct stages and under the proper conditions to maintain the integrity of the formulation.

4. Accountability

The Head of Creams Manufacturing is responsible for overseeing the process of adding active ingredients in cream manufacturing. The QA Manager is accountable for ensuring compliance with this SOP and that the final cream product meets the required quality standards.

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5. Procedure

5.1 Preparation of Active Ingredients

  1. Confirm that all active ingredients to be added to the cream formulation are available, correctly weighed, and within their specified shelf life. These may include:

    • Vitamins (e.g., Vitamin E, Vitamin C)
    • Herbal extracts
    • Anti-aging compounds
    • Moisturizing agents (e.g., Hyaluronic Acid, Glycerin)
    • Preservatives (if required)
  2. Inspect the active ingredients for integrity, ensuring they are free from contamination and stored correctly before use.
  3. Ensure the active ingredients are mixed or prepared according to the manufacturer’s guidelines (e.g., solubilized in a suitable carrier or dissolved in a compatible solvent).

5.2 Verifying Active Ingredients with Master Formula Record (MFR)

  1. Review the Master Formula Record (MFR) to confirm the correct active ingredients, quantities, and method of addition to the cream formulation.
  2. The MFR should outline the sequence of addition (i.e., whether the active ingredients should be added to the oil phase, water phase, or after emulsification) to avoid compromising their efficacy.
  3. Ensure that the active ingredients are within the specified concentration limits and check for any special handling instructions, such as temperature restrictions or solubility requirements.

5.3 Timing and Sequence of Addition

  1. Determine the correct stage of the manufacturing process to add the active ingredients. For most cream formulations, active ingredients are added after emulsification when the mixture has cooled to an appropriate temperature to prevent degradation of heat-sensitive compounds.
  2. If any heat-sensitive ingredients are included (e.g., vitamins, antioxidants), ensure that they are added at the appropriate stage, typically after cooling the emulsion base to prevent degradation.
  3. Follow the MFR to ensure the correct order of ingredient addition, especially if there are multiple active ingredients that need to be incorporated in different phases of the process.

5.4 Addition of Active Ingredients

  1. Add the active ingredients to the cream formulation in small, controlled amounts, ensuring uniform distribution throughout the mixture. Use high-shear mixing or homogenization if necessary to ensure thorough dispersion.
  2. Maintain the temperature of the mixture within the specified range during the addition of active ingredients to prevent any damage to the ingredients.
  3. Stir or mix continuously while adding the active ingredients to ensure uniform incorporation and prevent clumping or localized concentrations of the active ingredients.
  4. Monitor and document the addition process, including the quantity of active ingredients added, the time of addition, and any observations.
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5.5 Mixing and Homogenization

  1. After all active ingredients have been added, continue mixing the formulation to ensure even distribution of the ingredients throughout the cream base.
  2. Use a homogenizer or high-shear mixer to ensure that the active ingredients are completely blended with the emulsion base, particularly if the active ingredients are hydrophobic or have limited solubility.
  3. Monitor the viscosity of the mixture during mixing to ensure it remains within the specified range for the final product.

5.6 Quality Control Testing of Final Cream

  1. Once the active ingredients have been fully incorporated, conduct the following quality control tests on the cream formulation:

    • Viscosity: Ensure the cream meets the specified viscosity for the desired texture.
    • pH: Verify that the pH of the cream falls within the desired range, usually between 4.5 and 6.5, depending on the formulation.
    • Microbial Testing: Conduct microbial testing to confirm that the cream is free from harmful microorganisms.
    • Stability Testing: Perform stability tests to ensure that the active ingredients remain stable over time and under varying conditions (e.g., temperature, light exposure).
  2. If the cream passes the quality control tests, it is ready for packaging. If any issues arise during testing, further adjustments must be made to the formulation, and a new batch must be prepared.

5.7 Documentation and Reporting

  1. Document the entire process of adding active ingredients, including the batch number, list of active ingredients, quantities used, the time and method of addition, and any deviations from the standard process.
  2. Prepare a batch record and quality control report summarizing the process, testing results, and any actions taken during the formulation process.
  3. Submit the batch record and quality control report for review and approval by the QA team.
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5.8 Final Approval and Packaging

  1. Once the formulation passes all quality control tests and the batch record is approved by QA, the cream is ready for the final packaging process.
  2. The packaging team should follow the appropriate packaging procedures as outlined in the MFR and ensure that the product is sealed and labeled according to regulatory requirements.

6. Abbreviations

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

7. Documents

  1. Active Ingredient Addition Log (Annexure-1)
  2. Batch Record (Annexure-2)
  3. Quality Control Test Report (Annexure-3)

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: Active Ingredient Addition Log

Batch Number Active Ingredient Quantity Added Time of Addition Remarks
12345 Vitamin E 10 mg 09:00 AM Added after emulsification

Annexure-2: Batch Record

Batch Number Process Step Time Operator
12345 Adding Active Ingredients 09:15 AM Jane Doe

Annexure-3: Quality Control Test Report

Test Parameter Result Specification Remarks
Viscosity 3200 cP 3000-3500 cP Pass

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
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