QC Manager is accountable for ensuring that active ingredient testing is carried out accurately and in accordance with this SOP. The Production Supervisor is responsible for ensuring that samples are collected from the correct production stages. The QA Manager ensures the integrity and compliance of test results with regulatory requirements.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that all necessary equipment for active ingredient content testing is available, including analytical balances, HPLC (High-Performance Liquid Chromatography) system, and reagents for sample preparation.
2. Ensure that the HPLC system is calibrated and operating correctly, following the manufacturer’s instructions for validation.
3. Review the batch record to identify the appropriate sampling points for active ingredient testing, typically post-manufacturing and prior to packaging.

5.2 Sample Collection

1. Collect representative samples of the cream formulation from the batch at the designated sampling points. The sample size should be adequate for testing and should be free from contamination.
2. Label the sample with the batch number, sample ID, sampling date, and sampling point to ensure traceability during testing.
3. Ensure that the sample is homogenous, and take precautions to avoid cross-contamination when handling the sample.

5.3 Active Ingredient Testing Procedure

1. Prepare the sample by dissolving the cream formulation in a suitable solvent to extract the active ingredient. This may include using solvents such as ethanol or methanol depending on the active ingredient.
2. Filter the sample to remove any insoluble material, ensuring that only the active ingredient in solution is measured.
3. Perform the active ingredient quantification using a validated method such as:
   • High-Performance Liquid Chromatography (HPLC): Use the appropriate HPLC method and column for the active ingredient being tested. Ensure that the solvent, flow rate, and detector are set according to the test specifications.
   • UV Spectrophotometry: If applicable, use UV spectrophotometry for the quantification of active ingredients that absorb light at a specific wavelength.
   • Titration: If required, use a suitable titration method to quantify the active ingredient, based on its chemical properties.
4. Record the concentration of the active ingredient in the sample and compare it with the specification for the product. Ensure that the results are reproducible and accurate by performing the test in triplicate if necessary.

5.4 Interpretation of Results

1. Compare the test results with the product specifications for the active ingredient content. The active ingredient concentration should be within the acceptable range defined by the formulation requirements and regulatory guidelines.
2. If the active ingredient content falls outside the acceptable range, mark the test as “Fail.” Investigate the cause of the deviation and review the formulation and production process for any potential errors.
3. If the test results meet the required specifications, mark the test as “Pass” in the Active Ingredient Testing Log (Annexure-1) and proceed with the next stage of production or release.

5.5 Post-Test Activities

1. Record all test results, including batch number, sample ID, active ingredient content, and any corrective actions taken, in the Active Ingredient Testing Log (Annexure-1).
2. If the active ingredient content does not meet specifications, initiate corrective actions, such as reviewing raw material quality, formulation adjustments, or process optimization, and re-test the sample.
3. Submit the test results for review and approval by the QA team to ensure compliance with regulatory and internal standards before product release.

5.6 Documentation and Record-Keeping

1. Ensure that all records related to active ingredient content testing are complete, accurate, and securely stored. This includes the Active Ingredient 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
• HPLC: High-Performance Liquid Chromatography

7. Documents

1. Annexure-1: Active Ingredient Testing Log
2. Annexure-2: Deviation Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Pharmacopeial Monographs for Active Ingredient Testing

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 Testing Log

Batch Number	Sample ID	Sampling Date	Active Ingredient Content (%)	Operator
12345	S-001	21/01/2026	5%	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Low active ingredient content	Adjusted formulation, re-tested	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