performed. Reviews drying time data and approves the batch for further processing.

Maintenance Personnel: Ensures that drying equipment is calibrated, well-maintained, and functioning correctly to ensure accurate drying times and uniformity in results.

4. Accountability

The Production Manager is accountable for ensuring that the drying process is executed correctly and that the drying times meet the required specifications. The QA Manager is responsible for validating the drying time data and approving the batch for the next phase of production.

5. Procedure

5.1 Pre-Validation Setup

1. Ensure that the drying equipment is calibrated and functioning properly. Verify that all required temperature and humidity controls are set according to the batch record.
2. Prepare the tablet granules for drying and ensure that the moisture content prior to drying is within the acceptable range as specified in the formulation.
3. Ensure that all necessary equipment, including drying ovens, moisture analyzers, and sampling tools, are available and in working condition.
4. Review the batch record to ensure that the drying time parameters (temperature, humidity, and time) are correctly specified.

5.2 Determining Drying Time

1. Start the drying process by loading the tablet granules into the drying equipment. Set the drying temperature and airflow according to the predefined process parameters.
2. Monitor the drying process and periodically check the moisture content of the granules using a moisture analyzer at regular intervals (e.g., every 15 minutes).
3. Record the moisture content at each interval and compare the readings to the required moisture content specification for the granules. If the moisture content is above the specified range, extend the drying time.
4. Once the granules reach the desired moisture content, stop the drying process and document the total drying time.
5. For validation purposes, test multiple samples from different areas of the batch to ensure uniform drying and consistency in moisture content across the batch.

5.3 Validating Drying Time

1. After completing the drying process, verify the final moisture content of the granules by testing at multiple points in the batch. Ensure that the moisture content is within the acceptable range specified in the batch record.
2. If the moisture content is within the required range, document the results and finalize the drying time validation. The batch is now approved for the next stage of production.
3. If the moisture content is not within specification, repeat the drying process by adjusting the drying time, temperature, or humidity settings, and perform another set of moisture content tests.
4. For each validation run, ensure that all parameters are thoroughly documented, including drying time, temperature, humidity, and moisture content data (Annexure-1).

5.4 Post-Validation Review

1. After the drying time has been validated, conduct a review of the process to determine if any adjustments are needed for future production runs. This includes assessing the drying time consistency and efficiency.
2. Ensure that the drying time parameters are stable and that any changes in equipment or process conditions do not affect the tablet quality or drying time.
3. Document the results of the validation, including any corrective actions taken, in the batch record (Annexure-1).

5.5 Calibration and Maintenance of Drying Equipment

1. Perform regular calibration of drying equipment to ensure accuracy in temperature and humidity control. This ensures that the drying process operates within the specified parameters for each batch.
2. Inspect and clean the drying equipment after each production run to ensure optimal performance and prevent contamination from previous batches.
3. Document all calibration and maintenance activities in the equipment maintenance log (Annexure-2).

5.6 Documentation and Record-Keeping

1. Maintain detailed records of the drying time validation process, including initial moisture content, drying time, temperature, humidity settings, and final moisture content (Annexure-1).
2. Ensure that any deviations from the prescribed drying time parameters are documented in the deviation report (Annexure-3) and that corrective actions are recorded.
3. Store all records in compliance with the company’s document retention policy and ensure they are accessible for future audits or inspections.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

1. Batch Record (Annexure-1)
2. Equipment Maintenance Log (Annexure-2)
3. Deviation Report (Annexure-3)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – Good Manufacturing Practice Guide 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: Batch Record

Batch Number	Initial Moisture Content	Drying Time	Final Moisture Content	Comments
Batch 001	10%	45 minutes	3%	No deviations

Annexure-2: Equipment Maintenance Log

Maintenance Date	Equipment	Maintenance Performed	Performed By	Comments
01/12/2025	Drying Oven	Calibration and Cleaning	John Doe	Oven calibrated, no issues found

Annexure-3: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
12/12/2025	Batch 003	Moisture content above target	Extended drying time by 15 minutes	Jane Smith

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 Drying Time Parameters	Improved Efficiency	QA Head