SOP Guide for Pharma

Creams: SOP for Conducting Heavy Metal Testing in Creams – V 2.0

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Creams: SOP for Conducting Heavy Metal Testing in Creams – V 2.0

Standard Operating Procedure for Conducting Heavy Metal Testing in Creams

Department Creams
SOP No. SOP/CRM/142/2025
Supersedes SOP/CRM/142/2022
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 define the procedure for conducting heavy metal testing in cream formulations. Heavy metals, such as lead, arsenic, cadmium, and mercury, can be toxic even at low concentrations, making their presence in cosmetic products a critical quality and safety concern. This SOP ensures that creams are tested for heavy metals to meet regulatory standards and protect consumer health.

2. Scope

This SOP applies to all cream formulations produced at the facility, particularly those intended for direct consumer use. It includes procedures for testing cream samples for the presence of heavy metals during the production process and after the formulation is completed.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that heavy metal testing is performed in accordance with this SOP. The Production Supervisor is responsible for ensuring that the cream formulations are produced according to the established specifications to minimize contamination. The QA Manager ensures that the test results are reviewed and approved in compliance with GMP and regulatory standards.

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5. Procedure

5.1 Pre-Test Preparation

  1. Ensure that the necessary equipment for heavy metal testing is available, including an atomic absorption spectrophotometer (AAS), inductively coupled plasma mass spectrometer (ICP-MS), or any other suitable instruments for detecting heavy metals in cream formulations.
  2. Prepare the necessary reagents and calibration standards according to the testing method. Use certified reference materials (CRMs) for calibration.
  3. Review the batch record to confirm the ingredients used in the cream formulation and ensure that they meet safety standards with regard to heavy metal content.

5.2 Sample Collection

  1. Collect a representative sample of the finished cream formulation for heavy metal testing. Ensure the sample is homogenous and free from contamination.
  2. Label each sample with the batch number, sample ID, sampling date, and other relevant details to ensure traceability during testing.
  3. Ensure that the sample is taken from sealed containers to maintain the integrity of the formulation and prevent contamination during testing.

5.3 Heavy Metal Testing Procedure

  1. Prepare the sample for testing by diluting or digesting the cream formulation as required by the testing method. Follow the manufacturer’s instructions for sample preparation.
  2. Perform the heavy metal test using the appropriate method (e.g., AAS, ICP-MS, or others) to detect and quantify heavy metals such as lead, arsenic, cadmium, and mercury in the cream sample.
  3. For each sample, perform the test in triplicate to ensure consistency and reliability of the results.
  4. Record the results of the heavy metal test, including the concentration of each detected heavy metal, in the Heavy Metal Testing Log (Annexure-1).
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5.4 Interpretation of Results

  1. Compare the results of the heavy metal testing with the specified limits for each heavy metal. The acceptable limits for heavy metals are typically defined by regulatory agencies (e.g., FDA, EMA) and should be within the permissible thresholds.
  2. For example, the FDA specifies that the maximum allowable concentration for lead in cosmetic products should be less than 10 ppm (parts per million).
  3. If the heavy metal concentrations are within the acceptable range, mark the test as “Pass” in the Heavy Metal Testing Log (Annexure-1) and proceed with the next stage of production or release.
  4. If the heavy metal concentrations exceed the specified limits, mark the test as “Fail.” Investigate the cause of the contamination, which may include ingredient sourcing, equipment contamination, or improper handling practices.

5.5 Post-Test Activities

  1. Record all test results, including batch number, sample ID, heavy metal concentrations, and any corrective actions taken, in the Heavy Metal Testing Log (Annexure-1).
  2. If the heavy metal test fails, initiate corrective actions, such as revisiting the sourcing of ingredients, reworking the batch, or adjusting the formulation to minimize heavy metal contamination. Re-test the sample after corrective actions.
  3. Submit the test results for review and approval by the QA team to ensure compliance with internal and regulatory standards.

5.6 Documentation and Record-Keeping

  1. Ensure that all heavy metal testing records are complete, accurate, and securely stored. This includes the Heavy Metal 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: Heavy Metal 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: Heavy Metal Testing Log

Batch Number Sample ID Test Date Heavy Metal Concentration (ppm) Operator
12345 S-001 21/01/2026 Lead: 2 ppm, Arsenic: 0.5 ppm John Doe

Annexure-2: Deviation Log

Deviation Date Batch Number Deviation Description Corrective Action Taken Operator
21/01/2026 12345 Lead content exceeded permissible limits Re-sourced raw material, reprocessed the batch 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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