SOP Guide for Pharma

Creams: SOP for Analyzing Preservative Levels in Creams – V 2.0

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Creams: SOP for Analyzing Preservative Levels in Creams – V 2.0

Standard Operating Procedure for Analyzing Preservative Levels in Creams

Department Creams
SOP No. SOP/CRM/151/2025
Supersedes SOP/CRM/151/2022
Page No. Page 1 of 5
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

The purpose of this SOP is to outline the procedure for analyzing preservative levels in cream formulations. Preservatives are used in cream products to prevent microbial growth and extend shelf life. This SOP ensures that preservatives are present in the correct concentrations to effectively preserve the product without compromising safety or efficacy.

2. Scope

This SOP applies to all cream formulations manufactured at the facility that contain preservatives. It covers the procedure for testing and analyzing the preservative content in creams to ensure compliance with regulatory standards and internal specifications.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that preservative level testing is conducted in accordance with this SOP. The Production Supervisor is responsible for ensuring that preservatives are added according to the formulation and manufacturing process. The QA Manager ensures that the results of the preservative testing are reviewed and approved.

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5. Procedure

5.1 Pre-Test Preparation

  1. Ensure that all necessary equipment for preservative level analysis is available, including HPLC (High-Performance Liquid Chromatography), UV-Vis spectrophotometer, or other relevant instruments for preservative analysis.
  2. Review the batch record to confirm that the correct preservatives were added during the manufacturing process and in the appropriate concentrations.
  3. Prepare the cream sample for analysis. Ensure that the sample is properly homogenized and free from contamination. Label the sample with batch number, sample ID, and testing date for traceability.

5.2 Analytical Procedure for Preservative Testing

  1. For the analysis, prepare the sample by accurately weighing a known quantity of cream and diluting it in an appropriate solvent (e.g., methanol, water, or acetonitrile), as required by the specific preservative being analyzed.
  2. Use the appropriate analytical technique to determine the concentration of preservatives:
    • HPLC: Set up the HPLC system with the appropriate column, mobile phase, and detector settings. Inject a known volume of the prepared sample and record the peak area corresponding to the preservative(s) of interest.
    • UV-Vis Spectrophotometry: Set up the UV spectrophotometer at the specific wavelength for the preservative being tested. Measure the absorbance of the sample and compare it with a standard calibration curve.
  3. Record the results for each test, including batch number, sample ID, test date, and the preservative concentration, in the Preservative Testing Log (Annexure-1).
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5.3 Data Analysis and Interpretation

  1. Calculate the preservative concentration from the test results using the appropriate calibration curve or standard method. Compare the obtained value with the required specifications for the preservative concentration in the cream formulation.
  2. If the preservative concentration is within the acceptable limits, mark the test result as “Pass” and proceed with the next stage of production or release.
  3. If the preservative concentration is outside the acceptable range, mark the test result as “Fail.” Investigate the potential causes of deviation, which may include improper formulation, handling, or testing errors. Implement corrective actions as necessary and re-test the sample if required.

5.4 Post-Test Activities

  1. Record all results, including batch number, sample ID, test date, preservative concentration, and any deviations from the specifications, in the Preservative Testing Log (Annexure-1).
  2. If any deviations are identified, initiate corrective actions, such as adjusting the formulation or manufacturing process, and re-test the sample after corrective actions have been implemented.
  3. Submit the test results for review and approval by the QA team to ensure compliance with internal and regulatory standards.

5.5 Documentation and Record-Keeping

  1. Ensure that all preservative testing records are complete, accurate, and securely stored. This includes the Preservative Testing Log (Annexure-1) and the Deviation Log (Annexure-2) for failed tests.
  2. Retain all records for a minimum of two years or as required by regulatory guidelines.
  3. Ensure that records are reviewed and approved by the Quality Assurance team to verify compliance with GMP standards and regulatory requirements.
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6. Abbreviations

7. Documents

  1. Annexure-1: Preservative Testing Log
  2. Annexure-2: Deviation Log

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Preservative Testing Log

Batch Number Sample ID Test Date Preservative Used Concentration (%) Operator
12345 S-001 21/01/2026 Phenoxyethanol 0.75% John Doe

Annexure-2: Deviation Log

Deviation Date Batch Number Deviation Description Corrective Action Taken Operator
21/01/2026 12345 Preservative level below specification Reformulated batch to increase preservative content Jane Smith

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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