Creams: SOP for Analytical Testing of New Cream Formulations – V 2.0

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Creams: SOP for Analytical Testing of New Cream Formulations – V 2.0

Standard Operating Procedure for Analytical Testing of New Cream Formulations

Department Creams
SOP No. SOP/CRM/026/2025
Supersedes SOP/CRM/026/2022
Page No. Page 1 of 6
Issue Date 05/07/2025
Effective Date 10/07/2025
Review Date 05/07/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for conducting analytical testing of new cream formulations. Analytical testing is essential to ensure that the cream formulations meet established quality standards, including potency, stability, safety, and efficacy.

2. Scope

This SOP applies to all new cream formulations developed within the Creams Department. It covers the analytical testing processes, including chemical, physical, and microbiological testing, to evaluate the quality and consistency of the cream formulations before approval for commercial production.

3. Responsibilities

  • Formulation Development Team: Responsible for providing the formulation details, ingredients, and any preliminary data required for analytical testing.
  • Quality Control (QC): Responsible for performing the analytical tests, including stability, chemical analysis, viscosity, pH, and microbial testing, on the cream formulations and ensuring that all results meet specified criteria.
  • Quality Assurance (QA): Oversees the testing process to ensure compliance with regulatory standards and internal quality systems. QA also reviews and approves the final test results.
  • Regulatory Affairs: Ensures that the testing protocols and results comply with the applicable regulatory requirements for the cream product’s intended markets.

4. Accountability

The Head of Creams Manufacturing is responsible for overseeing the analytical testing process. The QA Manager is accountable for ensuring that all tests are performed in compliance with GMP standards and that the results are thoroughly documented and reviewed.

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5. Procedure

5.1 Test Method Selection

  1. Based on the product type and formulation, select the appropriate analytical methods for testing. These methods may include:

    • Viscosity testing
    • pH testing
    • Active ingredient analysis (e.g., HPLC, spectrophotometry)
    • Stability testing (accelerated and real-time conditions)
    • Microbial testing (if applicable)
  2. Ensure that the selected test methods are validated and suitable for the specific formulation. Refer to pharmacopeial monographs or internal standard methods where applicable.
  3. Ensure that the equipment used for testing is calibrated and properly maintained as per the equipment SOPs.

5.2 Sample Preparation

  1. Prepare representative samples of the cream formulation for testing. Each sample should be taken according to the sampling protocol, ensuring it is fully representative of the batch.
  2. Samples should be properly labeled with relevant information, including the batch number, date of sampling, and any other pertinent data.
  3. Store the samples appropriately to prevent contamination or degradation before testing (e.g., maintaining required temperature conditions).

5.3 Analytical Testing

  1. Perform the analytical tests on the cream samples according to the pre-defined test methods. Key tests include:

    • Viscosity Testing: Measure the cream’s resistance to flow, ensuring the correct texture and consistency.
    • pH Testing: Ensure that the pH of the cream formulation falls within the acceptable range for the intended skin application.
    • Active Ingredient Analysis: Quantify the active ingredients (e.g., through High-Performance Liquid Chromatography or spectrophotometry) to ensure that the formulation contains the correct concentration.
    • Stability Testing: Evaluate how the formulation behaves under different storage conditions (e.g., temperature, humidity, light) over time.
    • Microbial Testing: Ensure that the product is free from microbial contamination or meets required microbial limits (if applicable).
  2. Record the results of each test and compare them with the established specifications for the formulation.
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5.4 Evaluation of Results

  1. Analyze the test results to determine whether the cream formulation meets the required specifications. This includes comparing the actual test results with the acceptable limits defined in the formulation’s specification sheet.
  2. If any of the test results fall outside the specified range, investigate the cause of the deviation and implement corrective actions. This may include adjusting the formulation or reviewing the production process for potential errors.
  3. Document any deviations and corrective actions in the test report for review and approval by the QA team.

5.5 Documentation and Reporting

  1. Prepare a detailed Analytical Testing Report that includes the following information:

    • Batch number and formulation details
    • Test methods used and equipment details
    • Test results and any deviations from specifications
    • Corrective actions taken (if applicable)
    • Final approval status from QA
  2. Submit the Analytical Testing Report for review and approval by the QA team. Ensure that the report is signed off by all relevant personnel before proceeding to the next stage of development or production.
  3. Store the Analytical Testing Report in the product’s development records for future reference and regulatory submissions.

5.6 Final Approval

  1. The final approval for the cream formulation is contingent upon the successful completion of all analytical tests and the satisfactory review of the test results by the QA team.
  2. Once approved, the formulation can proceed to the next phase of development, such as scale-up or commercialization, based on the results of the analytical testing.
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6. Abbreviations

  • QC: Quality Control
  • QA: Quality Assurance
  • GMP: Good Manufacturing Practices
  • HPLC: High-Performance Liquid Chromatography
  • API: Active Pharmaceutical Ingredient

7. Documents

  1. Analytical Testing Report (Annexure-1)
  2. Sample Testing Log (Annexure-2)
  3. Formulation Development Log (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
  • USP/NF Monographs for Cream Formulations

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Analytical Testing Report

Test Type Test Result Test Date Approval Status
Viscosity Within specification 05/07/2025 Approved

Annexure-2: Sample Testing Log

Sample Name Batch Number Testing Date Test Results
Moisturizing Cream 12345 05/07/2025 Passed all tests

Annexure-3: Formulation Development Log

Formulation Name Batch Number Ingredients Process Description Testing Outcome
Anti-Aging Cream 67890 Retinol, Aloe Vera Mixing, Heating, Homogenization Passed viscosity, stability, and microbial tests

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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