results of allergen testing to ensure compliance with internal specifications and regulatory requirements.

4. Accountability

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

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that the necessary equipment for allergen testing is available, including suitable test kits (e.g., ELISA kits) and a properly calibrated laboratory balance for sample preparation.
2. Prepare the necessary reagents and calibration standards according to the testing method. Use certified reference materials (CRMs) for allergen calibration.
3. Review the batch record to confirm the formulation details, including the ingredients used, and identify potential allergens that need to be tested for.

5.2 Sample Collection

1. Collect a representative sample of the finished cream product. Ensure the sample is homogeneous 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 cross-contamination during testing.

5.3 Allergen Testing Procedure

1. Prepare the sample for allergen testing by following the manufacturer’s instructions for the specific test method (e.g., ELISA or PCR for allergens such as peanuts, tree nuts, dairy, gluten, etc.).
2. Perform the allergen test in triplicate to ensure consistency and reliability of the results. The sample should be prepared and tested under controlled conditions to avoid contamination.
3. Record the allergen content results for each test sample, noting the concentration of each allergen tested, in the Allergen Testing Log (Annexure-1).

5.4 Interpretation of Results

1. Compare the allergen test results with the specified limits for each allergen. The permissible levels for allergens are typically defined by regulatory agencies (e.g., FDA, EMA) and should be within the thresholds established for consumer safety.
2. For example, the FDA recommends that the maximum allowable concentration for peanuts or other allergens in cosmetics should be non-detectable or below the threshold level for allergic reactions.
3. If the test results show that the allergen concentration is within the acceptable range, mark the test as “Pass” in the Allergen Testing Log (Annexure-1) and proceed with the next stage of production or release.
4. If the test results show that the allergen concentration exceeds the specified limit, mark the test as “Fail.” Investigate the source of the contamination, which may include ingredients, equipment contamination, or cross-contamination during production.

5.5 Post-Test Activities

1. Record all test results, including batch number, sample ID, allergen concentrations, and any corrective actions taken, in the Allergen Testing Log (Annexure-1).
2. If the allergen test fails, initiate corrective actions such as revisiting the sourcing of ingredients, revising the formulation, or improving production processes to ensure that allergens are minimized or removed. 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 allergen testing records are complete, accurate, and securely stored. This includes the Allergen 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.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• ELISA: Enzyme-Linked Immunosorbent Assay

7. Documents

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

8. References

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

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Allergen Testing Log

Batch Number	Sample ID	Test Date	Allergen Concentration (ppm)	Operator
12345	S-001	21/01/2026	Peanuts: 0 ppm, Gluten: 0.2 ppm	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Gluten 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