SOP Guide for Pharma

Tablets: SOP for Moisture Content Testing in Granules and Tablets – V 2.0

Auditor

Tablets: SOP for Moisture Content Testing in Granules and Tablets – V 2.0

Standard Operating Procedure for Moisture Content Testing in Granules and Tablets

Department Tablet
SOP No. SOP/TAB/085/2025
Supersedes SOP/TAB/085/2022
Page No. Page 1 of 7
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To outline the procedure for moisture content testing in granules and tablets to ensure the proper moisture levels are maintained, preventing issues with stability, dissolution, and shelf life.

2. Scope

This SOP applies to the moisture content testing of both granules and tablets at various stages of manufacturing to verify that moisture levels are within the acceptable limits specified in the batch record or pharmacopeial guidelines.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that moisture content testing is conducted in compliance with this SOP and for reporting the results. The QA Manager is responsible for reviewing the results and approving the batch for release.

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5. Procedure

5.1 Sample Collection

  1. Collect a representative sample of granules or tablets from the batch, as specified in the batch record.
  2. The sample should consist of 6 tablets or an appropriate amount of granules (or as specified in the batch record or pharmacopeial guidelines).
  3. Ensure that the tablets or granules are free from defects, contamination, or other visible issues.
  4. Label the sample appropriately for identification during testing.

5.2 Preparation of Moisture Content Testing Apparatus

  1. Ensure that the moisture content testing apparatus, such as a moisture analyzer or an oven, is calibrated and functioning properly.
  2. Prepare the sample holder or petri dish and ensure that the balance used for weighing is accurate and properly calibrated.

5.3 Performing Moisture Content Test

  1. Weigh the sample (e.g., 5–10 grams of granules or 6 tablets) and record the initial weight in the batch record (Annexure-1).
  2. If using a moisture analyzer, place the sample on the instrument’s platform and follow the instructions to test the moisture content, ensuring that the moisture analyzer’s temperature is set as per the method (typically 105°C to 110°C for tablets).
  3. If using an oven method, place the sample in a preheated oven at the designated temperature (typically 105°C) for the specified time (usually 2–4 hours) and then cool it in a desiccator before weighing it again.
  4. For both methods, the moisture content is calculated based on the weight loss after drying.
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5.4 Data Recording and Calculation

  1. Record the final weight of the sample after drying and calculate the moisture content as follows:
    • Moisture Content (%) = (Initial Weight – Final Weight) / Initial Weight × 100
  2. Ensure that the moisture content is within the acceptable range specified in the batch record or pharmacopeial guidelines (typically ≤ 2% for tablets, but this may vary).
  3. Document the calculated moisture content in the batch record (Annexure-1) along with the testing method and any observations.

5.5 Moisture Content Acceptance Criteria

  1. Ensure that the moisture content of the granules or tablets falls within the specified limits. The typical range for tablets is between 1–2%, but this may vary depending on the product.
  2. If the moisture content exceeds the specified limits, investigate the cause, and document the findings in the deviation report (Annexure-2). Corrective actions should be implemented as necessary.

5.6 Documentation and Record-Keeping

  1. Document the moisture content testing results, including the initial and final weights, moisture content, and method used, in the batch record (Annexure-1).
  2. Record any deviations from the moisture content specifications in the deviation report (Annexure-2), along with corrective actions taken.
  3. Ensure all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.

5.7 Post-Test Cleanup

  1. Clean the moisture content testing apparatus, including the moisture analyzer or oven, according to the manufacturer’s instructions and the company’s cleaning SOP.
  2. Ensure that all equipment is properly stored and maintained in good working condition for future use.
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6. Abbreviations

7. Documents

  1. Batch Record (Annexure-1)
  2. Deviation Report (Annexure-2)

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: Batch Record

Batch Number Tablet Sample Initial Weight (g) Final Weight (g) Moisture Content (%)
Batch 001 6 tablets 5.20 5.10 1.92%

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
10/12/2025 Batch 001 Moisture content exceeded specification Adjusted granulation and drying process John Doe

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated Moisture Testing Method Refined moisture testing parameters QA Head
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