Manager is accountable for ensuring that moisture content testing is carried out accurately and in accordance with this SOP. The Production Supervisor is responsible for ensuring that the correct samples are provided for testing. The QA Manager ensures that testing results are reviewed for compliance with regulatory standards.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that all necessary equipment, including moisture analyzers or ovens, is calibrated and functioning properly.
2. Review the batch record to determine the appropriate sampling points for moisture content testing. Samples should be taken at the final stage of formulation, before packaging.
3. Ensure that the laboratory environment is clean and suitable for testing, and that all necessary materials, such as drying vessels, balance, and moisture analyzers, are available.

5.2 Sample Collection

1. Collect a representative sample of the cream formulation. The sample should be homogeneous and free from contamination.
2. Label the sample with the batch number, sampling date, and sampling point to ensure traceability during testing.
3. Ensure that the sample is at the correct temperature (if applicable), as moisture content may vary with temperature. Allow the sample to equilibrate to room temperature before testing if needed.

5.3 Moisture Content Testing Procedure

1. For the moisture content test, use a moisture analyzer or oven drying method, depending on the available equipment:
   • Moisture Analyzer Method: Place a known weight of the sample in the moisture analyzer and start the test. Follow the manufacturer’s instructions to heat and measure the moisture content.
   • Oven Drying Method: Weigh the sample and place it in a preheated oven at 105°C for a specified period (typically 2 hours). After drying, cool the sample in a desiccator and reweigh it to determine the moisture content.
2. Record the weight of the sample before and after drying or heating. Calculate the moisture content as the difference in weight, expressed as a percentage.
3. If the moisture content is above or below the acceptable range, mark the result as “Fail” and investigate potential causes (e.g., improper formulation, ingredient issues, or improper storage conditions).
4. Document all results in the Moisture Content Testing Log (Annexure-1), including the batch number, test method, test conditions, and moisture content percentage.

5.4 Interpretation of Results

1. Compare the moisture content values obtained with the product specifications for acceptable moisture levels. The moisture content should fall within the defined range specified for the product.
2. If the moisture content is within the acceptable range, mark the result as “Pass” in the Moisture Content Testing Log (Annexure-1) and proceed with the next stage of production.
3. If the moisture content is outside the acceptable range, investigate the cause of the deviation. This could involve reviewing the formulation, manufacturing process, or storage conditions.

5.5 Post-Test Activities

1. Record all test results, including batch number, sample ID, moisture content percentage, and corrective actions taken (if applicable) in the Moisture Content Testing Log (Annexure-1).
2. Ensure that all records are reviewed and approved by the QA team to verify compliance with internal specifications and regulatory requirements.
3. If the test results indicate a failure, initiate corrective actions, such as adjusting the formulation or production process, and re-test the sample to confirm that the moisture content falls within the specified limits.

5.6 Documentation and Record-Keeping

1. Ensure that all moisture content testing records are complete, accurate, and securely stored. This includes the Moisture Content 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 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

7. Documents

1. Annexure-1: Moisture Content 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 Moisture Content 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: Moisture Content Testing Log

Batch Number	Sample ID	Sampling Date	Moisture Content (%)	Operator
12345	S-001	21/01/2026	25%	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Moisture content above specification	Adjusted formulation and 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